General Meeting 9 th January 2017

1. General Meeting 9th January 2017

2. Agenda • Welcome • Update on the New members • Progress of the sub-groups • Comment on ICH E6 and MHRA data Integrity Guideline • eTMF Selection Subteam presentation • Inspection Readiness subgroup presentation • Update on eTMF conferences

3. New members since last meeting

4. SC Focus for 2017 • 6 general meetings over the year • Reassess and reprioritise initiative deliverables • Send out initiatives on a Survey Monkey for general opinion • Improve the initiative deliverables process • Set more strict timelines • Get more volunteers!

5. Activity Subgroups

6. ICH E6 Revision Compliance (Nov ‘16) • “The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.” • “A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.”

7. MHRA Consultation on Data Integrity • True copy vs certified copy vs verified copy • A copy of original information that been verified as an exact (accurate and complete) copy having all of the same attributes and information as the original. The copy may be verified by dated signature or by a validated electronic signature • Users (with the exception of system administrator) should not have the ability to amend or switch off the audit trail • A - attributable to the person generating the data; L – legible and permanent; C – contemporaneous; O – original record (or true copy); A – accurate

8. Inspection Preparation Output

9. Scope • Develop a toolkit of inspection preparation checklists, lessons learned and other resources that are available in the public domain • As part of the toolkit, we set out to define roles and responsibilities • Work began: 29 April 2016 • Work completed: 02 November 2016

10. Members of the Group

11. Gatheringbestpractices • List of tasks/activitiesperformed to prepare for inspectionwerelisted • Roleswerealsoadded, but the rolesvaried a lotbetweencompanies • Decision was made to develop a RACI thatcanbeadapted to the size and roles of each organisation

12. Inspection Readiness RACI Columns added to beused for organisation-specificroles Tasksaregrouped to easeoverview Definition of key elements; used to ensurecommonunderstanding of the content of the task Short description of the actualtask or process step Indication of whether the task is relevant for eTMF or paper

13. eTMF Selection GCP SubteamOverview for the TMF Reference Model Jamie TothDirector, TMF OperationsDaiichi Sankyo Inc.

14. Topics • Scope • Industry Collaboration • Team Members • Timeline • eTMF Selection Categories and Snapshot • Next Steps • Contact/About Info

15. Scope • Develop a template that others in the industry can utilize when selecting an eTMF system that meets Regulatory requirements. • The template will be generic focusing on criteria for selection of an eTMF system to be used in any jurisdiction and with any regulations, staying vendor agnostic, taking into account industry guidance. Team Members: Jamie Toth, Russell Joyce, Ged Murphy Work began: November 2015 Work was ready for review: June 2016 Work completed: Brought together 5 data sources of requirements into one large listing in Excel, and consolidated to 449 requirements and over different categories, which got whittled down to 16 categories and 229 rows. Designated Desirable (D) vs. Essential (E) requirements and listed regulatory citations for most all (E).

16. Industry Collaboration • Pocket EDMS announced with draft URS to the public 17-Mar-2016 • Pocket EDMS accepted by DIA as newest Reference Model • TMF Reference Model committee was asked to collaborate with Pocket EDMS to develop TMF Extension, as SAG-GCP already had as an initiative that was near completion, SAG-GCP was asked to lead this. • Steve Scribner and DimitriStamatiadis met with the SAG-GCP eTMF Selection group on 15-Jul-2016 • Steve and Dimitri went through their assessment of eTMF Selection group work on 02-Aug-2016 • Communication went out to TMF Reference Model Working Group on 04-Aug-2016 for volunteers

17. Team Members

18. Timeline • August 2016 – Kick off meeting held • Five meetings held through November 2016 • December 2016 – Listing was finalized and ready for QC within the group

19. eTMF Selection - Categories • 15 categories* • 184 unique requirements* • *As of 05-Jan-2017, may change after Final QC completes

20. eTMF Selection - Snapshot A B C D E F G • Essential – E or Desirable – D: Most E have a Regulatory requirement included • In Pocket: If the requirement is also in Pocket EDMS • Pocket URS Reference: The location of where in Pocket EDMS the requirement resides • Category: The category the requirement resides (15) • Description: A full description of the requirement • Regulatory Requirement: The reference to the regulation that the requirement may be in • Applicable Text: Completed if Regulatory Requirement is filled in A B C D E F G

21. Next Steps • Finishing Final QC by end of January 2017 • Will add references tab about Pocket EDMS, SAG, etc. • Will publish as a white paper on SAG website and be publicly available by February 2017

22. Contact Info • Scientific Archivist Group (SAG):http://www.sagroup.org.uk/ and the GCP special interest groups (SIGs) http://www.sagroup.org.uk/sighome/sig-gcpContact Jamie Toth jtoth@dsi.com • Pocket EDMS:  Pocket EDMS documentation can be found at www.pocketedms.wordpress.com and the discussion forum at www.pocketedms.freeforums.netContact Steve Scribner Steve@ScribnerGroupInc.com or DimitriStamatiadisDimitri@MAIAconsulting.eu

23. eTMF Conferences coming up • EXL TMF Summit, Orlando, Jan 17 to 19 • SCOPE meeting – Miami, Jan 24 to 26 • DIA RSIDM Meeting – Bethesda, Feb 6 to 8

24. TMF RM General Meetings • 9-Jan • 27-Feb • 24-Apr • 12-Jun

25. QUESTIONS? Join the TMF Reference Model Yahoo! Group http://tmfrefmodel.com/join • Knowledge sharing • Networking • Too Much Fun!