CDISC FDA Electronic Submission

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The presentation is intended for those who need to prepare CDISC electronic submission to agency. The paper will discuss why we need to understand CDISC electronic submission. It will explain the significant regulatory changes lately such as FDASIA and PDUFA V. It will also discuss how to prepare CDISC electronic submission such as eCTD and FDA CDER Data Standard Strategy and finally what to prepare for CDISC electronic submission such as CSR, Protocol, SAP, SDTM annotated eCRF, SDTM datasets, ADaM datasets, ADaM datasets SAS Programs and Define.xml and their formats.

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CDISC FDA Electronic Submission

  1. 1. www.cytel.com CDISC Electronic Submission Kevin Lee JSM August 6th, 2013 1
  2. 2. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Disclaimer 2 Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company.
  3. 3. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Why? 3
  4. 4. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Golden Rule by Simon Sinek 4 What How Why
  5. 5. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Agenda 5 • Why do we care CDISC electronic submission? – Recent Regulatory changes – FDASIA and PDUFA V • How can we prepare CDISC electronic submission? – eCTD version 3.2.2 and Data Standard Strategy • What do we prepare CDISC electronic submission? – CDISC components – CDISC electronic submission • Conclusion • Questions & Answers
  6. 6. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Current Status of eSubmission in FDA 6
  7. 7. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Current Status in CDISC Submission 7 CDISC submission • In 2010, CDER received an average of over 650 datasets/week, with 23% of active NDAs containing CDISC/SDTM data • In 2011 this number has increased to an average 39% in SDTM and 32% in ADaM
  8. 8. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Significant Regulatory Changes 8 FDA Safety and Innovation Act (FDASIA) • signed into law on July 9, 2012. • expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health. • Main impacts for us - reauthorizes the fifth instance of Prescription Drug User Fee Act (PDUFA V)
  9. 9. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. PDUFA V commitment by FDASIA 9 • Provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. • FDA will continue to receive a source of stable and consistent funding during fiscal years 2013-2017 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients
  10. 10. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. PDUFA V commitment in section 7 10 A. To enhance the quality and efficiency of FDA’s review of NDAs, BLAs, and INDs, FDA shall consult with stakeholders, including pharmaceutical manufacturers and other research sponsors, to issue draft guidance on the standards and format of electronic submission of applications by December 31, 2012. B. FDA will issue final guidance no later than 12 months from the close of the public comment period on the draft guidance. Such final guidance and any subsequent revisions to the final guidance shall be binding on sponsors, applicants, and manufacturers no earlier than twenty-four months after issuance of the final guidance.
  11. 11. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. PDUFA V commitment in section 7 (2) 11 C. Requirements for electronic submission shall be phased in according to the following schedule: 1. Twenty-four (24) months after publication of the final guidance: All new original NDA and BLA submissions, all new NDA and BLA efficacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions. 2. Thirty-six (36) months after publication of the final guidance: All original commercial INDs and amendments
  12. 12. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. PDUFA V commitment in section 7 (3) 12 D. ….., initial FDA guidance shall specify the format of electronic submission of applications using eCTD version 3.2.2 unless, after notice and an opportunity for stakeholder comment, FDA determines that another version will provide for more efficient and effective applicant submission or FDA review.
  13. 13. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. PDUFA V commitment in section 7 (4) 13 E. Clinical Terminology Standards: …., FDA shall develop standardized clinical data terminology through open standards development organizations (i.e., the Clinical Data Interchange Standards Consortium (CDISC)) with the goal of completing clinical data terminology and detailed implementation guides by FY 2017. 1. FDA shall develop a project plan for distinct therapeutic indications, prioritizing clinical terminology standards development within and across review divisions.
  14. 14. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. More Updates from FDA on DIA 2013 14 • FDA is currently developing eCTD v 4.0. • Implementation Target – Mandatory eCTD submission – NDA and BLA : March 2016 – Commercial INDs : March 2017 • Based on the current implementation schedule, FDA begins receiving eCTD v 4.0 submission in 2016
  15. 15. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. How do we prepare CDISC eSubmission? 15 • eCTD(Electronic Common Technical Document) v 3.2.2 for electronic submission • Data Standard Strategy for CDISC
  16. 16. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Electronic Common Technical Document 16 • Introduction of eCTD – an interface for industry to agency transfer of regulatory information • Most recent version – v3.2.2 • Define – Module and its contents • Module 1 – Administrative information • Module 2 – eCTD summary document • Module 3 – Quality • Module 4 – Non-clinical Study Reports • Module 5 – Clinical Study Reports – File formats (i.e., pdf, txt, xml, xpt and etc)
  17. 17. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Electronic Common Technical Document 17
  18. 18. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Data Standard Strategy 18 • Purpose – to reinforce CDER’s on-going commitment to the development, implementation and maintenance of data standard program on regulatory submissions. • Objectives – Development of TA standards – Replacement of SAS XPORT files – Requirement of eSubmission • Data Standard – CDER initiated 55 key TA domains – CDISC will be implemented and enhanced to support TA standard development
  19. 19. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. TA Data Standard Prioritization 19
  20. 20. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Data Standard Strategy 20
  21. 21. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. What do we prepare for CDISC eSubmission? 21 • CDISC components according to CDISC compliances • Its electronic formats according to eCTD
  22. 22. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. CDISC Clinical Trial Process 22 PRN (Protocol) eCRF ODM.xml, L AB SDTM TFLADaM SAP CDASH CSR
  23. 23. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. CDISC components in eSubmission 23 • Protocol • SAP • eCRF • SDTM • ADaM • SEND • CSR • Define.xml
  24. 24. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Additional components in eSubmission 24 • ADaM SAS programs • Efficacy SAS programs (sometimes)
  25. 25. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Formats of files according to eCTD 25 • Protocol – pdf (i.e., study001-protocol.pdf) • SAP – pdf (i.e., sutdy001-sap.pdf) • eCRF – pdf (i.e., sutdy001-blankecrf.pdf) • SDTM – xpt (i.e., dm.xpt, ae.xpt, ds.xpt, and etc) • ADaM – xpt (i.e., adsl.xpt, adae.xpt, adtteos.xpt, and etc) • SEND – xpt (i.e., dm.xpt, se.xpt, bw.xpt, and etc) • CSR – pdf (i.e., sutdy001-csr.pdf) • Define.xml – xml or pdf (i.e., define.xml/define.pdf) • ADaM SAS programs – txt (i.e., c-adsl-sas.txt) • Efficacy SAS programs – txt (i.e., t-14-01-001-ds-sas.txt )
  26. 26. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Naming convention of files according to eCTD 26 • Lower case of letter from “a” to “z” • Number from “0” to “9” • “-” hypen • No special character ( #, %, $ and etc) • File name should be less than or equal to 64 characters including the appropriate file extension • The length of entire path of the file should not exceed 230 characters. (m5/datasets/study001/sdtm/ae.xpt)
  27. 27. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. pdf file guideline according to eCTD 27 • Version – 1.4 thru 1.7 are acceptable • Fonts – Standard : Arial, Courier New, Times Roman – Sizes : range from 9 to 12 point ( Times New Roman 12-point font is recommended for narrative text ) • Page – Print area : 8.5 inches by 11 inches – Margin : at least ¾ inch
  28. 28. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. SAS xpt file guideline according to eCTD 28 • Length – Variable length is less than or equal to 8 – Variable label is less than or equal to 40 – Dataset length is less than or equal to 8 – Dataset label is less than or equal to 40 • Dataset Size – less than 1 GB (LB1, LB2, and so on) • The length of character variables should be minimized (i.e., if the maximum length of USUBJID is 20 character long, keep the length as 20, not 200)
  29. 29. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Module 5 CSR Reports 29 CSR, SAP, Protocol
  30. 30. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. CDISC Datasets eSubmission 30 ADaM datasets, Define.xml ADaM SAS programs SDTM datasets, Define.xml, SDTM annotated blank eCRF
  31. 31. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. CDISC compliance 31 • SEND : config-send-3.0.xml • SDTM : config-sdtm-3.1.3.xml • ADaM : config-adam-1.0.xml • Define : config-define-2.0.xml • CDISC compliance by OpenCDISC
  32. 32. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Conclusion 32 • Before : “should” in FDA documents means that something is suggested or recommended, but not required. • After : “should” could mean required. • CDISC electronic submission will be mandatory sometime in 2016 or 2017.
  33. 33. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Contacts 33 • Email address : Kevin.lee@cytel.com • Linkedin : – Profile : www.linkedin.com/in/kevinlee1995/ – Group : CDISC ADaM • Tweet : @kevinlee_pharma or @cdisc_adam
  34. 34. www.cytel.com ©2013 Cytel Statistical Software & Services Pvt. Ltd. Questions? 34

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