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Activities conducted during SIV
Presented by – Manasi Dhamal, Mayuri Bhome, Dr. Geetu Mohan, Adil Shaikh
Content
 What is SIV?
 Preparation for SIV
 Activities conducted during SIV
 Essential Documents required
 References
www.siroinstitute.com SIRO Clinical Research Institute
What is SIV?
 SIV :- Site Initiation Visit
 Once the site is selected, a Site Initiation Visit (SIV) is planned to provide
study-specific information & training to investigators and staff before
study start-up by CRA from sponsor/CRO .
 Once all FQ and SQV done and required documents are collected and
approvals are in place, sites can be initiated.
 The initiation process involves several steps.
www.siroinstitute.com SIRO Clinical Research Institute
Preparation for SIV (1/4)
• Timing for Conduct of SIV
I
• Sponsor Preparation
II
• Site Preparation
III
www.siroinstitute.com SIRO Clinical Research Institute
Preparation for SIV (2/4)
I. Timing For Conduct of SIV :-
 Before Patient enrollment.
 After all essential documents are in place.
 After supplies received.
 After Institutional Review Board(IRB) Approval.
www.siroinstitute.com SIRO Clinical Research Institute
Preparation for SIV (3/4)
II. Sponsor Preparation :-
 Set a manually agreed-upon meeting time.
 Send prepared agenda with expected attendees.
 Send all Study-related materials in advance for
review.
 Send supplies.
www.siroinstitute.com SIRO Clinical Research Institute
Preparation for SIV (4/4)
III. Site Preparation :-
 Review protocol and any other documents received by sponsor/CRO (i.e.
CRFs, IB).
 Become familiar with the study procedures.
 Confirm supplies received (i.e. Drug ,Binders, test tubes, Regulatory
binder, etc.
 Write down questions for sponsor/CRO when reviewing documents.
 Secure room.
 Ensure staff availability for the visit.
www.siroinstitute.com SIRO Clinical Research Institute
Activities involved during SIV
SCHEDULED
SIV
SHIP SUPPLIES
SITE TRAINING
FOLLOW UP
www.siroinstitute.com SIRO Clinical Research Institute
Activities involved during SIV (1/4)
 The PI will arrange a date and time as requested by the sponsor that is
convenient for all if not as many members of the clinical study team as possible.
www.siroinstitute.com SIRO Clinical Research Institute
STEP 1 : SCHEDULED
SIV
 The following are shipped to site to be made available on the SIV date:-
 Study Protocol
 IP
 Other supplies such as lab kits
 Other relevant study materials
www.siroinstitute.com SIRO Clinical Research Institute
STEP 2 : SHIP SUPPLIES
Activities involved during SIV (2/4)
Activities involved during SIV (3/4)
 During SIV, all site staff must be trained.
 Here are some of the required trainings :-
 Good Clinical Practice
 Study Protocol
 CRFs
 Study procedures
 IP handling and accountability
 PI and staff responsibilities
 Subject Safety
www.siroinstitute.com SIRO Clinical Research Institute
STEP 3 : TRAINING
Activities involved during SIV (4/4)
 After the visit, the monitor will complete a
monitoring report for the sponsor and send a
follow-up letter to the site.
 Resolutions to any unresolved questions that came
up during the visit will also be included in the letter.
www.siroinstitute.com SIRO Clinical Research Institute
STEP 4 : FOLLOW
UP
Essential Documents in SIV
Sr.
No.
Document Stage Filing Location
SMF TMF
1 Instructions for handling
of IP(s) and trial related
materials
Before Trial × ×
2 Shipping records of
IP(s) and trial related
materials
Before Trial × ×
www.siroinstitute.com SIRO Clinical Research Institute
Essential Documents in SIV
Sr.
No.
Document Stage Filing Location
SMF TMF
3 Certificates of
Analysis(COA) of IP(s)
shipped
Before Trial ×
4 Trial Initiation
Monitoring Report (SIV
Report)
Before Trial × ×
www.siroinstitute.com SIRO Clinical Research Institute
References
 https://prezi.com/n8t5isvqvrv_/site-initiation-visit/
 https://florencehc.com/blog-post/the-future-site-
initiation-visit-with-eisf-capabilities/
www.siroinstitute.com SIRO Clinical Research Institute
www.siroinstitute.com SIRO Clinical Research Institute

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Activities conducted during Site Initiation Visit (SIV).pptx

  • 1. Activities conducted during SIV Presented by – Manasi Dhamal, Mayuri Bhome, Dr. Geetu Mohan, Adil Shaikh
  • 2. Content  What is SIV?  Preparation for SIV  Activities conducted during SIV  Essential Documents required  References www.siroinstitute.com SIRO Clinical Research Institute
  • 3. What is SIV?  SIV :- Site Initiation Visit  Once the site is selected, a Site Initiation Visit (SIV) is planned to provide study-specific information & training to investigators and staff before study start-up by CRA from sponsor/CRO .  Once all FQ and SQV done and required documents are collected and approvals are in place, sites can be initiated.  The initiation process involves several steps. www.siroinstitute.com SIRO Clinical Research Institute
  • 4. Preparation for SIV (1/4) • Timing for Conduct of SIV I • Sponsor Preparation II • Site Preparation III www.siroinstitute.com SIRO Clinical Research Institute
  • 5. Preparation for SIV (2/4) I. Timing For Conduct of SIV :-  Before Patient enrollment.  After all essential documents are in place.  After supplies received.  After Institutional Review Board(IRB) Approval. www.siroinstitute.com SIRO Clinical Research Institute
  • 6. Preparation for SIV (3/4) II. Sponsor Preparation :-  Set a manually agreed-upon meeting time.  Send prepared agenda with expected attendees.  Send all Study-related materials in advance for review.  Send supplies. www.siroinstitute.com SIRO Clinical Research Institute
  • 7. Preparation for SIV (4/4) III. Site Preparation :-  Review protocol and any other documents received by sponsor/CRO (i.e. CRFs, IB).  Become familiar with the study procedures.  Confirm supplies received (i.e. Drug ,Binders, test tubes, Regulatory binder, etc.  Write down questions for sponsor/CRO when reviewing documents.  Secure room.  Ensure staff availability for the visit. www.siroinstitute.com SIRO Clinical Research Institute
  • 8. Activities involved during SIV SCHEDULED SIV SHIP SUPPLIES SITE TRAINING FOLLOW UP www.siroinstitute.com SIRO Clinical Research Institute
  • 9. Activities involved during SIV (1/4)  The PI will arrange a date and time as requested by the sponsor that is convenient for all if not as many members of the clinical study team as possible. www.siroinstitute.com SIRO Clinical Research Institute STEP 1 : SCHEDULED SIV
  • 10.  The following are shipped to site to be made available on the SIV date:-  Study Protocol  IP  Other supplies such as lab kits  Other relevant study materials www.siroinstitute.com SIRO Clinical Research Institute STEP 2 : SHIP SUPPLIES Activities involved during SIV (2/4)
  • 11. Activities involved during SIV (3/4)  During SIV, all site staff must be trained.  Here are some of the required trainings :-  Good Clinical Practice  Study Protocol  CRFs  Study procedures  IP handling and accountability  PI and staff responsibilities  Subject Safety www.siroinstitute.com SIRO Clinical Research Institute STEP 3 : TRAINING
  • 12. Activities involved during SIV (4/4)  After the visit, the monitor will complete a monitoring report for the sponsor and send a follow-up letter to the site.  Resolutions to any unresolved questions that came up during the visit will also be included in the letter. www.siroinstitute.com SIRO Clinical Research Institute STEP 4 : FOLLOW UP
  • 13. Essential Documents in SIV Sr. No. Document Stage Filing Location SMF TMF 1 Instructions for handling of IP(s) and trial related materials Before Trial × × 2 Shipping records of IP(s) and trial related materials Before Trial × × www.siroinstitute.com SIRO Clinical Research Institute
  • 14. Essential Documents in SIV Sr. No. Document Stage Filing Location SMF TMF 3 Certificates of Analysis(COA) of IP(s) shipped Before Trial × 4 Trial Initiation Monitoring Report (SIV Report) Before Trial × × www.siroinstitute.com SIRO Clinical Research Institute