SlideShare a Scribd company logo

INA104_570_Protocol Deviation Log_08DEC2020.doc

•Download as DOC, PDF•
•
F
faisal992205

protocol

Healthcare
1 of 33
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702043 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/JUL/ 2018 23/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702044 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/JUL/ 2018 23/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702045 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/JUL/ 2018 24/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702046 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/JUL/ 2018 24/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702047 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/JUL/ 2018 25/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702048 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 30/JUL/ 2018 30/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702049 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 30/JUL/ 2018 30/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702050 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 31/JUL/ 2018 31/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702051 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 31/JUL/ 2018 31/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702052 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 01/AUG/ 2018 01/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702053 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702054 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702055 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702056 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 07/AUG/ 2018 07/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702057 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 08/AUG/ 2018 08/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702058 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/AUG/ 2018 13/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702059 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/AUG/ 2018 13/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702060 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 14/AUG/ 2018 14/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702061 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 14/AUG/ 2018 14/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702062 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 15/AUG/ 2018 15/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702063 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 20/AUG/ 2018 20/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702064 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 20/AUG/ 2018 20/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702065 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 21/AUG/ 2018 21/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702066 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 21/AUG/ 2018 21/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702067 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/AUG/ 2018 23/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702068 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 27/AUG/ 2018 27/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702069 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 27/AUG/ 2018 27/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702070 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 28/AUG/ 2018 28/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702071 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 28/AUG/ 2018 28/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702072 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 29/AUG/ 2018 29/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702073 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 03/SEP/ 2018 03/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702074 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 03/SEP/ 2018 03/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702075 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 04/SEP/ 2018 04/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702076 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 04/SEP/ 2018 04/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702077 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 05/SEP/ 2018 05/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702078 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 10/SEP/ 2018 10/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702079 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 10/SEP/ 2018 10/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702080 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 12/SEP/ 2018 12/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702081 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/SEP/ 2018 13/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702082 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/SEP/ 2018 13/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702083 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702084 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702085 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702086 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 18/SEP/ 2018 18/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702087 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 19/SEP/ 2018 19/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702088 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/SEP/ 2018 24/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702089 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/SEP/ 2018 24/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702090 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/SEP/ 2018 25/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702091 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/SEP/ 2018 25/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702092 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 26/SEP/ 2018 26/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702022 Subjek salah menulis bulan pada lembar ICF, seharusnya 06/JUN/2018, tertulis 06/MEI/2018 06/JUN/ 2018 19/DEC/ 2018 N 11 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW dan melakukan koreksi pada lembar ICF disertai keterangan initial dan tanggal 1045702029 Subjek salah menulis bulan pada lembar ICF, seharusnya 02/JUL/2018, tertulis 02/JUN/2018 02/JUL/ 2018 19/DEC/ 2018 N 11 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW dan melakukan koreksi pada lembar ICF disertai keterangan initial dan tanggal 1045702059 Melakukan pengulangan pemeriksaan CD4 dengan alat PIMA sebanyak 2 kali tanpa berkoordinasi dengan pihak sekretariat terlebih dahulu 22/APR/ 2019 03/SEP/ 2019 N 61 Koreksi : melengkapi protocol deviasi minor form pada SDW dan protocol deviation log Pencegahan : melakukan koordinasi dengan CRSS bila didapatkan 2x error pada pemeriksaan CD4 1045702077 Tidak didapatkan hasil CD4 karena dari 2x pemeriksaan hasil error dengan kode 205. Berdasarkan buku manual PIMA, tindakan untuk error kode 205 adalah “contact your local distributor” karena alat mengalami kerusakan 26/APR/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702228 Tidak didapatkan hasil CD4 karena dari 2x pemeriksaan hasil error dengan kode 205. Berdasarkan buku manual PIMA, tindakan untuk error kode 205 adalah “contact your local distributor” karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702063 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702096 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702229 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702057 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702024 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702132 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702144 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702230 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702231 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702039 Pada pemeriksaan pertama PIMA CD4 didapatkan error. Kemudian dilakukan pemeriksaan ulangan (kedua) didapatkan error. Tidak dilakukan pemeriksaan ulangan (ketiga) karena sampel darah kurang. [Informasi tertera dalam lampiran email judul: INA104 : Protocol Deviation Site 570 tanggal 03/OCT/2019] 20/SEP/ 2019 20/SEP/ 2019 N 61 1. RA mengikuti refresher training PIMA Analyzer dari INA-RESPOND Reference Lab Team pada tanggal 02/OCT/2019 melalui teleconference 2. Site team berdiskusi dengan Co-PI Sp.PK dan menyepakati bahwa LT memisahkan >100µL whole blood untuk pemeriksaan PIMA CD4 agar mencukupi pemeriksaan CD4 maksimal 3x * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702021 Pada pemeriksaan pertama PIMA CD4 didapatkan cartridge tidak dapat terisi penuh. Pemeriksaan ulangan (kedua) didapatkan error. Pemeriksaan ulangan (ketiga) juga didapatkan error (Pemeriksaan ulangan ketiga setelah mendapatkan persetujuan sekretariat) 30/SEP/ 2019 30/SEP/ 2019 N 61 1. Merekam video pengerjaan PIMA yang dilakukan oleh LT dan menguploadnya di portal EDMS untuk direview oleh INA-RESPOND Reference Lab Team 2. LT mengikuti Refresher training PIMA Analyzer dari INA-RESPOND Reference Lab Team melalui TC 1045702243 Hasil viral load invalid, dilakukan pengulangan 1x tapi hasil tidak bisa dilihat karena hard disk rusak. Alat tidak bisa digunakan untuk pengulangan yang kedua. 21/MAY/ 2019 30/JAN /2020 N 33 Menghubungi petugas teknisi pada tanggal 21/MAY/2019, petugas datang pada tanggal 22/ MAY/2019. Kemudian alat dapat berfungsi kembali pada tanggal 28/MAY/2019. 1045702026 Pada saat kunjungan FUM 06 (06/MAR/2019), dilakukan proses reconsent pada subyek, setelah diberikan penjelasan dan waktu untuk membaca, subyek menyatakan setuju melanjutkan keikutsertaan dalam studi ini. Subyek menandatangani 2 rangkap ICF, namun ada satu copy yang peneliti (RA) terlewat melengkapi dan menandatangani informed consent (copy yang disimpan di SDW) 06/MAR/ 2019 29/JUL/ 2019 N 19 1. Membuat NTF 2. Melengkapi SDW versi 2.0 PD Log * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702029 Subyek dan RA salah menulis bulan, seharusnya 02/JUL/2018, tertulisnya 02/JUN/2018 02/JUL/ 2018 19/DEC/ 2018 N 11 1. Menulis di atas ICF atas kesalahan tersebut diberi inisial dan tanggal. 2. Mengisi PD Log, keduanya dengan kode 11 (Berdasarkan arahan CRA). 3. Melengkapi halaman PD di SDW 1045702244 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 22/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler. 1045702042 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 22/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702072 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702049 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702048 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702007 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 24/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702120 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 24/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702245 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 27/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702067 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 27/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702246 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 28/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702076 Pengulangan pemeriksaan viral load (hasil awal berupa “no result”) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi piham vendor untuk memaintain alat GeneXpert 1045702151 Pengulangan pemeriksaan viral load (hasil awal berupa “no result”) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi piham vendor untuk memaintain alat GeneXpert 1045702003 04/JUN/20 20 04/JUN/20 20 N 33 * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702003 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702006 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702234 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702247 Pemeriksaan CD4 tidak dilakukan di hari yang sama dengan pengambilan darah karena alat pima CD4 mengalami kerusakan dan membutuhkan penggantian sparepart. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log 1045702249 Pemeriksaan CD4 tidak dilakukan di hari yang sama dengan pengambilan darah karena alat pima CD4 mengalami kerusakan dan membutuhkan penggantian sparepart. 04/JUN/20 20 05/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702135 CD4 test is not done due to the PIMA instrument is out of order. 06/MAY/ 2019 29/JUN/ 2019 N 33 CORRECTIVE ACTION: Completing PD Form and PD Log PREVENTIVE ACTION: Periodic maintenance for the PIMA instrument 1045702045 Pengulangan pemeriksaan viral load (hasil awal berupa no result) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi pihak vendor untuk memaintain alat genexpert 1045702034 Pada kunjungan FUM 24, sifilis dites ulang oleh LT dengan hasil reaktif, walaupun pada kunjungan sebelumnya (FUM 06) hasil tes sifilis adalah positif 07/AUG/ 2020 07/AUG/ 2020 N 33 RA melengkapi PD log SDW page 1300 dan melakukan data entry ke OC. RA menulis keterangan tentang kejadian ini pada lembar INA Respond lab result halaman ke2. RA akan mengingatkan LT tentang hasil sifilis tes pada kunjungan terakhir. RA dapat membuat catatan pada post it rangkuman hasil tes sifilis pada setiap kunjungan lalu ditaruh pada SDW 1045702262 Sampel darah lisis lipemik, pemeriksaan VL I hasil invalid, sudah lapor sekretariat. Tanggal 25/AUG/2020, dr. Dona menyarankan untuk dilakukan pemeriksaan VL II dan keluar hasil 24/AUG/ 2020 24/AUG/ 2020 N 33 Memberitahukan ke pasien untuk mencoba periksa kolesterol. Mengingatkan pasien untuk mengurangi konsumsi makanan kolesterol tinggi ± 1 minggu sebelum pemeriksaan darah lagi. Mengisi PD Form dan PD log 1045702161 Pemeriksaan VL dikerjakan >24 jam dari pengambilan darah karena kesalahan memaknai NTF 14 Sep 2020. Pemeriksaan VL I hasil invalid, lalu diulang di hari yang sama dengan keluar hasil 21/SEP/ 2020 22/SEP/ 2020 N 33 Mengisi PD form dan PD log. Membaca dan memahami ulang isi NTF 14 Sep 2020, dan bertanya ke sekretariat jika ada yang belum dipahami 1045702272 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 23/SEP/ 2020 23/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702272 - - - - - VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702263 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 23/SEP/ 2020 23/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702166 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702304 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702307 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702182 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702183 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702185 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702187 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 28/SEP/ 2020 28/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702275 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702043 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702189 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702198 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 02/OCT/ 2020 02/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702040 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 05/OCT/ 2020 05/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702184 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 05/OCT/ 2020 05/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702060 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 06OCT/ 2020 06/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045802059 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702167 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702186 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 06/OCT/ 2020 06/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702171 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702068 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 13/OCT/ 2020 13/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702069 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 13/OCT/ 2020 13/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702086 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 14/OCT/ 2020 14/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702179 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 14/OCT/ 2020 14/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702048 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 15/OCT/ 2020 15/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702065 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 15/OCT/ 2020 15/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702057 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702067 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702188 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702221 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702079 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702191 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 02/NOV/ 2020 02/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702190 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702206 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702219 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702203 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 10/NOV/ 2020 10/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045701001 Pemeriksaan CD4 menghabiskan 3 cartridge. Running I hasil testnot finished error 200. Running II hasil invalid test error 910. Running III (atas izin sekretariat) hasil invalid test error 910 08/DEC/ 2020 08/DEC/ 2020 N 33 Melengkapi PD Form SDW page 1300 dan PD log. Mengentry open clinica 1045701001 Tidak didapatkan hasil cd4 pada follow up 30 karena sampai 3x pemeriksaan cd4 hasil eror semua 08/DEC/ 2020 08/DEC/ 2020 N 33 Melengkapi PD Form SDW page 1300 dan PD log. Mengentry open clinica VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL

Recommended

SCORE Exchange 2023 for international student
SCORE Exchange 2023 for international studentSCORE Exchange 2023 for international student
SCORE Exchange 2023 for international studentfaisal992205
 
Maintaining Momentum: Project, Time, and Self-Management
Maintaining Momentum: Project, Time, and Self-ManagementMaintaining Momentum: Project, Time, and Self-Management
Maintaining Momentum: Project, Time, and Self-Managementfaisal992205
 
2024 State of Marketing Report – by Hubspot
2024 State of Marketing Report – by Hubspot2024 State of Marketing Report – by Hubspot
2024 State of Marketing Report – by HubspotMarius Sescu
 
Everything You Need To Know About ChatGPT
Everything You Need To Know About ChatGPTEverything You Need To Know About ChatGPT
Everything You Need To Know About ChatGPTExpeed Software
 
Product Design Trends in 2024 | Teenage Engineerings
Product Design Trends in 2024 | Teenage EngineeringsProduct Design Trends in 2024 | Teenage Engineerings
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
 
How Race, Age and Gender Shape Attitudes Towards Mental Health
How Race, Age and Gender Shape Attitudes Towards Mental HealthHow Race, Age and Gender Shape Attitudes Towards Mental Health
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
 
AI Trends in Creative Operations 2024 by Artwork Flow.pdf
AI Trends in Creative Operations 2024 by Artwork Flow.pdfAI Trends in Creative Operations 2024 by Artwork Flow.pdf
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
 
Skeleton Culture Code
Skeleton Culture CodeSkeleton Culture Code
Skeleton Culture CodeSkeleton Technologies
 

Recommended

SCORE Exchange 2023 for international student
SCORE Exchange 2023 for international studentSCORE Exchange 2023 for international student
SCORE Exchange 2023 for international studentfaisal992205
 
Maintaining Momentum: Project, Time, and Self-Management
Maintaining Momentum: Project, Time, and Self-ManagementMaintaining Momentum: Project, Time, and Self-Management
Maintaining Momentum: Project, Time, and Self-Managementfaisal992205
 
2024 State of Marketing Report – by Hubspot
2024 State of Marketing Report – by Hubspot2024 State of Marketing Report – by Hubspot
2024 State of Marketing Report – by HubspotMarius Sescu
 
Everything You Need To Know About ChatGPT
Everything You Need To Know About ChatGPTEverything You Need To Know About ChatGPT
Everything You Need To Know About ChatGPTExpeed Software
 
Product Design Trends in 2024 | Teenage Engineerings
Product Design Trends in 2024 | Teenage EngineeringsProduct Design Trends in 2024 | Teenage Engineerings
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
 
How Race, Age and Gender Shape Attitudes Towards Mental Health
How Race, Age and Gender Shape Attitudes Towards Mental HealthHow Race, Age and Gender Shape Attitudes Towards Mental Health
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
 
AI Trends in Creative Operations 2024 by Artwork Flow.pdf
AI Trends in Creative Operations 2024 by Artwork Flow.pdfAI Trends in Creative Operations 2024 by Artwork Flow.pdf
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
 
Skeleton Culture Code
Skeleton Culture CodeSkeleton Culture Code
Skeleton Culture CodeSkeleton Technologies
 
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetJalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in LahoreBest Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in LahoreDeny Daniel
 
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetHubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetraisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun UttrakhandDehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhandindiancallgirl4rent
 
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...Ahmedabad Call Girls
 
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetNanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance PaymentsEscorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance PaymentsAhmedabad Call Girls
 
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetBareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMalda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetErnakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Chandigarh
 
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real MeetVip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real MeetAhmedabad Call Girls
 
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetThoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetTirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...Joya Singh
 
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali PunjabCall Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali PunjabSheetaleventcompany
 
PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024Neil Kimberley
 
Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)contently
 

More Related Content

Recently uploaded

Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetJalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in LahoreBest Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in LahoreDeny Daniel
 
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetHubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetraisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun UttrakhandDehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhandindiancallgirl4rent
 
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...Ahmedabad Call Girls
 
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetNanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance PaymentsEscorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance PaymentsAhmedabad Call Girls
 
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetBareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMalda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetErnakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Chandigarh
 
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real MeetVip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real MeetAhmedabad Call Girls
 
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetThoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetTirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...Joya Singh
 
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetCall Girls Service
 
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali PunjabCall Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali PunjabSheetaleventcompany
 

Recently uploaded (20)

Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetJalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Jalna Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in LahoreBest Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
Best Lahore Escorts 😮‍💨03250114445 || VIP escorts in Lahore
 
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetHubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Hubli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetraisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
raisen Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meetooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
ooty Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun UttrakhandDehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
 
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
(Deeksha) 💓 9920725232 💓High Profile Call Girls Navi Mumbai You Can Get The S...
 
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetNanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Nanded Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance PaymentsEscorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
Escorts Service Ahmedabad🌹6367187148 🌹 No Need For Advance Payments
 
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetBareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Bareilly Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetMalda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Malda Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetErnakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Ernakulam Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real MeetVip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
Vip Call Girls Makarba 👙 6367187148 👙 Genuine WhatsApp Number for Real Meet
 
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetThoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Thoothukudi Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sangli Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetTirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Tirupati Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
(Big Boobs Indian Girls) 💓 9257276172 💓High Profile Call Girls Jaipur You Can...
 
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real MeetSambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Sambalpur Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
 
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali PunjabCall Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
Call Girls Service Mohali {7435815124} ❤️VVIP PALAK Call Girl in Mohali Punjab
 

Featured

PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024Neil Kimberley
 
Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)contently
 
How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024Albert Qian
 
Social Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsSocial Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsKurio // The Social Media Age(ncy)
 
Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
 
5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summarySpeakerHub
 
ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
 
Getting into the tech field. what next
Getting into the tech field. what next Getting into the tech field. what next
Getting into the tech field. what next Tessa Mero
 
Google's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentGoogle's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentLily Ray
 
Time Management & Productivity - Best Practices
Time Management & Productivity - Best PracticesTime Management & Productivity - Best Practices
Time Management & Productivity - Best PracticesVit Horky
 
The six step guide to practical project management
The six step guide to practical project managementThe six step guide to practical project management
The six step guide to practical project managementMindGenius
 
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...RachelPearson36
 
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Applitools
 
12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at WorkGetSmarter
 
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...DevGAMM Conference
 
Barbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationBarbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationErica Santiago
 

Featured (20)

PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024PEPSICO Presentation to CAGNY Conference Feb 2024
PEPSICO Presentation to CAGNY Conference Feb 2024
 
Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)Content Methodology: A Best Practices Report (Webinar)
Content Methodology: A Best Practices Report (Webinar)
 
How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024
 
Social Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsSocial Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie Insights
 
Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024
 
5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary
 
ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd
 
Getting into the tech field. what next
Getting into the tech field. what next Getting into the tech field. what next
Getting into the tech field. what next
 
Google's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentGoogle's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search Intent
 
How to have difficult conversations
How to have difficult conversations How to have difficult conversations
How to have difficult conversations
 
Introduction to Data Science
Introduction to Data ScienceIntroduction to Data Science
Introduction to Data Science
 
Time Management & Productivity - Best Practices
Time Management & Productivity - Best PracticesTime Management & Productivity - Best Practices
Time Management & Productivity - Best Practices
 
The six step guide to practical project management
The six step guide to practical project managementThe six step guide to practical project management
The six step guide to practical project management
 
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
 
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
 
12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work
 
ChatGPT webinar slides
ChatGPT webinar slidesChatGPT webinar slides
ChatGPT webinar slides
 
More than Just Lines on a Map: Best Practices for U.S Bike Routes
More than Just Lines on a Map: Best Practices for U.S Bike RoutesMore than Just Lines on a Map: Best Practices for U.S Bike Routes
More than Just Lines on a Map: Best Practices for U.S Bike Routes
 
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
 
Barbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationBarbie - Brand Strategy Presentation
Barbie - Brand Strategy Presentation
 

INA104_570_Protocol Deviation Log_08DEC2020.doc

  • 1. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702043 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/JUL/ 2018 23/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702044 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/JUL/ 2018 23/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702045 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/JUL/ 2018 24/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702046 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/JUL/ 2018 24/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702047 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/JUL/ 2018 25/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702048 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 30/JUL/ 2018 30/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 2. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702049 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 30/JUL/ 2018 30/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702050 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 31/JUL/ 2018 31/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702051 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 31/JUL/ 2018 31/JUL/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702052 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 01/AUG/ 2018 01/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702053 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702054 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 3. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702055 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 06/AUG/ 2018 06/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702056 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 07/AUG/ 2018 07/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702057 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 08/AUG/ 2018 08/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702058 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/AUG/ 2018 13/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702059 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/AUG/ 2018 13/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702060 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 14/AUG/ 2018 14/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 4. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702061 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 14/AUG/ 2018 14/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702062 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 15/AUG/ 2018 15/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702063 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 20/AUG/ 2018 20/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702064 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 20/AUG/ 2018 20/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702065 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 21/AUG/ 2018 21/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702066 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 21/AUG/ 2018 21/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 5. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702067 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 23/AUG/ 2018 23/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702068 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 27/AUG/ 2018 27/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702069 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 27/AUG/ 2018 27/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702070 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 28/AUG/ 2018 28/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702071 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 28/AUG/ 2018 28/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702072 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 29/AUG/ 2018 29/AUG/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 6. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702073 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 03/SEP/ 2018 03/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702074 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 03/SEP/ 2018 03/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702075 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 04/SEP/ 2018 04/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702076 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 04/SEP/ 2018 04/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702077 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 05/SEP/ 2018 05/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702078 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 10/SEP/ 2018 10/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 7. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702079 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 10/SEP/ 2018 10/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702080 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 12/SEP/ 2018 12/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702081 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/SEP/ 2018 13/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702082 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 13/SEP/ 2018 13/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702083 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702084 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 8. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702085 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 17/SEP/ 2018 17/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702086 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 18/SEP/ 2018 18/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702087 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 19/SEP/ 2018 19/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702088 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/SEP/ 2018 24/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702089 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 24/SEP/ 2018 24/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702090 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/SEP/ 2018 25/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 9. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702091 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 25/SEP/ 2018 25/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702092 Pada tanggal 23 Juli 2018, Protocol Versi 2.0 sudah diimplementasikan, tetapi pemeriksaan CD4 belum dilakukan karena alat belum sampai 26/SEP/ 2018 26/SEP/ 2018 N 33 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW 1045702022 Subjek salah menulis bulan pada lembar ICF, seharusnya 06/JUN/2018, tertulis 06/MEI/2018 06/JUN/ 2018 19/DEC/ 2018 N 11 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW dan melakukan koreksi pada lembar ICF disertai keterangan initial dan tanggal 1045702029 Subjek salah menulis bulan pada lembar ICF, seharusnya 02/JUL/2018, tertulis 02/JUN/2018 02/JUL/ 2018 19/DEC/ 2018 N 11 Melengkapi protocol deviasi minor pada CRF halaman 1300 dan log pada SDW dan melakukan koreksi pada lembar ICF disertai keterangan initial dan tanggal 1045702059 Melakukan pengulangan pemeriksaan CD4 dengan alat PIMA sebanyak 2 kali tanpa berkoordinasi dengan pihak sekretariat terlebih dahulu 22/APR/ 2019 03/SEP/ 2019 N 61 Koreksi : melengkapi protocol deviasi minor form pada SDW dan protocol deviation log Pencegahan : melakukan koordinasi dengan CRSS bila didapatkan 2x error pada pemeriksaan CD4 1045702077 Tidak didapatkan hasil CD4 karena dari 2x pemeriksaan hasil error dengan kode 205. Berdasarkan buku manual PIMA, tindakan untuk error kode 205 adalah “contact your local distributor” karena alat mengalami kerusakan 26/APR/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 10. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702228 Tidak didapatkan hasil CD4 karena dari 2x pemeriksaan hasil error dengan kode 205. Berdasarkan buku manual PIMA, tindakan untuk error kode 205 adalah “contact your local distributor” karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702063 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702096 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702229 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 02/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702057 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702024 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 11. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702132 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702144 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702230 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702231 Tidak dilakukan pemeriksaan CD4 dengan alat PIMA karena alat mengalami kerusakan 06/MAY/ 2019 03/SEP/ 2019 N 33 Koreksi : melengkapi PD Form pada SDW dan PD Log Pencegahan : melakukan maintenance alat PIMA 1045702039 Pada pemeriksaan pertama PIMA CD4 didapatkan error. Kemudian dilakukan pemeriksaan ulangan (kedua) didapatkan error. Tidak dilakukan pemeriksaan ulangan (ketiga) karena sampel darah kurang. [Informasi tertera dalam lampiran email judul: INA104 : Protocol Deviation Site 570 tanggal 03/OCT/2019] 20/SEP/ 2019 20/SEP/ 2019 N 61 1. RA mengikuti refresher training PIMA Analyzer dari INA-RESPOND Reference Lab Team pada tanggal 02/OCT/2019 melalui teleconference 2. Site team berdiskusi dengan Co-PI Sp.PK dan menyepakati bahwa LT memisahkan >100µL whole blood untuk pemeriksaan PIMA CD4 agar mencukupi pemeriksaan CD4 maksimal 3x * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 12. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702021 Pada pemeriksaan pertama PIMA CD4 didapatkan cartridge tidak dapat terisi penuh. Pemeriksaan ulangan (kedua) didapatkan error. Pemeriksaan ulangan (ketiga) juga didapatkan error (Pemeriksaan ulangan ketiga setelah mendapatkan persetujuan sekretariat) 30/SEP/ 2019 30/SEP/ 2019 N 61 1. Merekam video pengerjaan PIMA yang dilakukan oleh LT dan menguploadnya di portal EDMS untuk direview oleh INA-RESPOND Reference Lab Team 2. LT mengikuti Refresher training PIMA Analyzer dari INA-RESPOND Reference Lab Team melalui TC 1045702243 Hasil viral load invalid, dilakukan pengulangan 1x tapi hasil tidak bisa dilihat karena hard disk rusak. Alat tidak bisa digunakan untuk pengulangan yang kedua. 21/MAY/ 2019 30/JAN /2020 N 33 Menghubungi petugas teknisi pada tanggal 21/MAY/2019, petugas datang pada tanggal 22/ MAY/2019. Kemudian alat dapat berfungsi kembali pada tanggal 28/MAY/2019. 1045702026 Pada saat kunjungan FUM 06 (06/MAR/2019), dilakukan proses reconsent pada subyek, setelah diberikan penjelasan dan waktu untuk membaca, subyek menyatakan setuju melanjutkan keikutsertaan dalam studi ini. Subyek menandatangani 2 rangkap ICF, namun ada satu copy yang peneliti (RA) terlewat melengkapi dan menandatangani informed consent (copy yang disimpan di SDW) 06/MAR/ 2019 29/JUL/ 2019 N 19 1. Membuat NTF 2. Melengkapi SDW versi 2.0 PD Log * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 13. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702029 Subyek dan RA salah menulis bulan, seharusnya 02/JUL/2018, tertulisnya 02/JUN/2018 02/JUL/ 2018 19/DEC/ 2018 N 11 1. Menulis di atas ICF atas kesalahan tersebut diberi inisial dan tanggal. 2. Mengisi PD Log, keduanya dengan kode 11 (Berdasarkan arahan CRA). 3. Melengkapi halaman PD di SDW 1045702244 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 22/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler. 1045702042 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 22/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702072 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702049 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702048 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 23/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 29 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702007 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 24/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 14. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702120 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 24/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702245 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 27/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702067 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 27/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702246 Alat GeneXpert Viral load mengalami loading lama yang disebabkan karena kerusakan hard disk 28/MAY/ 2019 26/FEB/ 2020 N 33 Menghubungi teknisi, sampel disimpan dalam freezer menunggu alat berfungsi kembali, pemeriksaan Viral Load dilakukan pada tanggal 31 Mei 2019. Alat akan dilakukan maintenance secara reguler 1045702076 Pengulangan pemeriksaan viral load (hasil awal berupa “no result”) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi piham vendor untuk memaintain alat GeneXpert 1045702151 Pengulangan pemeriksaan viral load (hasil awal berupa “no result”) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi piham vendor untuk memaintain alat GeneXpert 1045702003 04/JUN/20 20 04/JUN/20 20 N 33 * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 15. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702003 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702006 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702234 Pemeriksaan CD4 tidak dilakukan di hari yang sama dg pengambilan darah krn alat pima CD4 mengalami kerusakan & membutuhkan penggantian spare part. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. 1045702247 Pemeriksaan CD4 tidak dilakukan di hari yang sama dengan pengambilan darah karena alat pima CD4 mengalami kerusakan dan membutuhkan penggantian sparepart. 04/JUN/20 20 04/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log 1045702249 Pemeriksaan CD4 tidak dilakukan di hari yang sama dengan pengambilan darah karena alat pima CD4 mengalami kerusakan dan membutuhkan penggantian sparepart. 04/JUN/20 20 05/JUN/20 20 N 33 Pemeriksaan CD4 dikerjakan pada tanggal 07 JUNI 2020 dengan melakukan penggantian plat pada alat PIMA CD4. Melengkapi PD Form dan PD Log. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 16. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702135 CD4 test is not done due to the PIMA instrument is out of order. 06/MAY/ 2019 29/JUN/ 2019 N 33 CORRECTIVE ACTION: Completing PD Form and PD Log PREVENTIVE ACTION: Periodic maintenance for the PIMA instrument 1045702045 Pengulangan pemeriksaan viral load (hasil awal berupa no result) baru dilakukan keesokan harinya 10/MAR/ 2020 11/MAR/ 2020 N 33 Pengulangan pemeriksaan dilakukan di hari yang sama. Menghubungi pihak vendor untuk memaintain alat genexpert 1045702034 Pada kunjungan FUM 24, sifilis dites ulang oleh LT dengan hasil reaktif, walaupun pada kunjungan sebelumnya (FUM 06) hasil tes sifilis adalah positif 07/AUG/ 2020 07/AUG/ 2020 N 33 RA melengkapi PD log SDW page 1300 dan melakukan data entry ke OC. RA menulis keterangan tentang kejadian ini pada lembar INA Respond lab result halaman ke2. RA akan mengingatkan LT tentang hasil sifilis tes pada kunjungan terakhir. RA dapat membuat catatan pada post it rangkuman hasil tes sifilis pada setiap kunjungan lalu ditaruh pada SDW 1045702262 Sampel darah lisis lipemik, pemeriksaan VL I hasil invalid, sudah lapor sekretariat. Tanggal 25/AUG/2020, dr. Dona menyarankan untuk dilakukan pemeriksaan VL II dan keluar hasil 24/AUG/ 2020 24/AUG/ 2020 N 33 Memberitahukan ke pasien untuk mencoba periksa kolesterol. Mengingatkan pasien untuk mengurangi konsumsi makanan kolesterol tinggi ± 1 minggu sebelum pemeriksaan darah lagi. Mengisi PD Form dan PD log 1045702161 Pemeriksaan VL dikerjakan >24 jam dari pengambilan darah karena kesalahan memaknai NTF 14 Sep 2020. Pemeriksaan VL I hasil invalid, lalu diulang di hari yang sama dengan keluar hasil 21/SEP/ 2020 22/SEP/ 2020 N 33 Mengisi PD form dan PD log. Membaca dan memahami ulang isi NTF 14 Sep 2020, dan bertanya ke sekretariat jika ada yang belum dipahami 1045702272 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 23/SEP/ 2020 23/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 17. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702272 - - - - - VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702263 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 23/SEP/ 2020 23/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702166 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 18. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702304 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702307 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 24/SEP/ 2020 24/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702182 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 19. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702183 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702185 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 29/SEP/ 2020 29/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702187 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 28/SEP/ 2020 28/SEP/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 20. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702275 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702043 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702189 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 01/OCT/ 2020 01/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 21. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702198 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 02/OCT/ 2020 02/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702040 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 05/OCT/ 2020 05/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702184 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 05/OCT/ 2020 05/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 22. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702060 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 06OCT/ 2020 06/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045802059 VL testing was conducted more than 24 hour because of the unavailability of genexpert cartridge at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected subjects number & its follow up visits number. RA is to complete PD log, SDW page 1300, enter data into OC. VL testing will be performed once the cartridge is available using stored plasma as per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan. Preventive action : RA is to manage VL cartridge supply availability for subject’s follow up visits in next approximately 3 months period. 1045702167 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 23. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702186 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 06/OCT/ 2020 06/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702171 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 07/OCT/ 2020 07/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702068 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 13/OCT/ 2020 13/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 24. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702069 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 13/OCT/ 2020 13/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702086 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 14/OCT/ 2020 14/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702179 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 14/OCT/ 2020 14/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 25. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702048 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 15/OCT/ 2020 15/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702065 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 15/OCT/ 2020 15/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702057 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 26. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702067 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702188 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702221 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 27. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702079 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702191 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 02/NOV/ 2020 02/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702190 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 28. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045702206 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702219 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 09/NOV/ 2020 09/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. 1045702203 VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 10/NOV/ 2020 10/NOV/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 29. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) 1045701001 Pemeriksaan CD4 menghabiskan 3 cartridge. Running I hasil testnot finished error 200. Running II hasil invalid test error 910. Running III (atas izin sekretariat) hasil invalid test error 910 08/DEC/ 2020 08/DEC/ 2020 N 33 Melengkapi PD Form SDW page 1300 dan PD log. Mengentry open clinica 1045701001 Tidak didapatkan hasil cd4 pada follow up 30 karena sampai 3x pemeriksaan cd4 hasil eror semua 08/DEC/ 2020 08/DEC/ 2020 N 33 Melengkapi PD Form SDW page 1300 dan PD log. Mengentry open clinica VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 30. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 31. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 32. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL Protocol Deviations Log – INA104 PI Name: Prof. Usman Hadi, dr., PhD, Sp.PD-KPTI Site Name: RSUD Dr. Soetomo Subject ID Brief Description of the Issue Date Issue Occurred Date Issue was Identified Minor Deviation (N) or Major Deviation (J) N/J Code* For Minor Deviations: For Major Deviations: Date IRB was notified Corrective and Preventative Action Major Deviation Form # (attach form) VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 21/OCT/ 2020 21/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. VL testing is conducted more than 24 hour after blood sampling as genexpert cartridge is unavailable at site due to re-supply issue from manufacturer 26/OCT/ 2020 26/OCT/ 2020 N 39 (Delay VL testing ) Corrective action : RA is to report to INA Respond Secretariat for affected SIDs and FUMs. RA is to complete PD log, SDW page 1300, and to enter data into OC. VL testing will be performed once the cartridge is available using stored plasma per NTF guideline dated 14 Sep 2020 & petunjuk pengisian dokumen untuk VL tersimpan dated 15 Sep 2020. Preventive action : RA is to manage genexpert cartridge supply availability at site for subject’s follow up visits approximately within the next 3 months. * Refer to Classification of Protocol and Regulatory Deviation Codes – Protocol ID PI Signature: _______________________________________ Date: _______________
  • 33. INA102 – L-INA-011.02 Protocol Deviations Log Effective date 28 Mar 2016 Page ___of ___ CONFIDENTIAL