Digital Transformation: Best Practice For TMF/ e TMF Documentation Processes

1. Digital Transformation: Best Practice For TMF/eTMF Documentation Processes Jackie Morrill, Executive Director of Clinical Operations LMK Clinical Research Consulting

2. Today’s Agenda

3. About LMK Inspection Readiness. Two words that can ignite worry, fear, and stress. At LMK, we work with our clients to alleviate those concerns and ensure that you are inspection ready from Day One. We believe that the clinical trial content is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. LMK takes a proactive approach and makes clinical trial content quality a top priority on an ongoing basis - from start through closeout - not just pending an inspection or trial completion. • Founded in 2013 • HQ in Charlotte, NC • Only TMF company certified by WBENC • eTMF Agnostic company • All employees are TMF University Certified • Clients based in North America

4. The Golden Rule Of Clinical Research

5. If it isn’t written down, it didn’t happen!

6. Trial Master File (TMF)

7. Regulatory Requirement

8. ICH GCP • Guidance for Industry on Good Clinical Practice (GCP) • Published in 1996 by the International Conference on Harmonization (ICH) • Provides a unified standard for the US, EU, and Japan to facilitate mutual acceptance of clinical data by the regulatory authorities

9. European Medicines Agency (EMA) Clinical Trial Regulation EU No. 536/2014

10. FDA General Requirements Data Quality Requirements

11. The complete TMF is the basis for inspection and all the documents in it must be made available to the inspectors. Electronic source data and source documentation must meet the same fundamental elements of data quality (e.g., attributable, legible, contemporaneous, original, and accurate) that are expected of paper records. MHRA GCP Guidance for Clinical Trials …the TMF should be updated and completed in a timely manner. FDA Guidance for Industry Computerized Systems Used in Clinical Investigations, supplement to Part 11, Electronic Records EMA Guideline on the Content, Management and Archiving of the Clinical Trial Master File (Paper and/or Electronic)

12. Inspection Ready TMF Trifecta

13. With All That Being Said…

14. Why Does THIS Happen?

15. Why Does it Matter?

16. How Do We Ensure our TMF is Inspection Ready?

17. How do you ESTablish TMF Inspection Readiness?

18. Key Elements for success

19. Process Laying the Foundation

20. Process

21. Process

22. Roles and Responsibilities

23. Process

24. ICH GCP Section 8

25. Historical Landscape

26. Challenges

27. Goals

28. TMF Reference Model Team • Initially formed in 2009 • Supported by the Document and Records Management subgroup of the Drug Information Association (DIA) • Today the group is composed of ~850 representatives from more than 200 organizations

29. TMF Reference Model

30. TMF Reference Model Workbook

31. Organization • 01: Trial Management • 02: Central Trial Documents • 03: Regulatory • 04: IRB/IEC and Other Approvals • 05: Site Management • 06: IP and Trial Supplies • 07: Safety Reporting • 08: Centralized and Local Testing • 09: Third Parties • 10: Data Management • 11: Statistics

32. Document Types

33. Challenges

34. Customization Enterprise Level Study Level

35. Do you Really Need that Signature?

36. Wet-Ink Documents Dated Signature Validated Process

37. Poll Question I have written and/or processed a NTF in the past 30 days? • Yes • No

38. Note To File (NTF)

39. No More NTFs!

40. Process

41. Authoritative Source • Multiple storage locations and/or systems • Best Practice: • Consolidate documentation • Document your authoritative source

42. TMF Index • Authoritative source road map for your TMF that tells you: • What • Who • Where • When

43. TMF Index

44. Challenges

45. Process

46. Document Lifecycle

47. Challenges

48. Process

49. Requirements

50. Quality Specifications