General Meeting 9th January 2017 Agenda Welcome Update

General Meeting 9th January 2017 Agenda Welcome  Update

General Meeting 9th January 2017 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 New members since last meeting Byrne Teresa InClinica USA Last name First name Carpena Jolly

Clouting Davis Gott Gundell Kast Heather Tracey Samantha Kevin Melanie Kim Lucas Malia McCormick Melbourne Mhlanga Miller Patrick Rollins Ryan Schreck Yanghee Britton Joanne

Laura Sue Menzi Jennifer Lorna Holly Casey Kathy Company BioMarin HC Clinical Research Consulting RTI International Quotient Clinical Pharmacyclics Boehringer-Ingelheim International Vaccine Institute Rho Quality Prime Usona Institute Quotient Clinical Pharma Consulting Group Wright Medical Quotient Clinical

Health Decisions C.R. Bard, Inc ClinicalRM Country Type USA CRO Sponsor USA USA UK USA Germany Consultant Non-profit CRO Sponsor Sponsor Republic of Korea USA

USA USA UK Sweden USA UK USA USA USA Non-profit Sponsor Consultant Sponsor CRO CRO Sponsor CRO CRO Sponsor CRO 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! Activity Subgroups Group Lead Metadata Todd Tullis Implementation toolkit / Upgrade Mike Czaplicki User Guide Eric Rubinson Dating conventions Melissa Maberry IN DISCUSSION Sub-artifacts Karin Schneider Inspection Preparation Kathie Clark - TODAY Sholeh Ehdaivand TMF Quality Country specific artifacts Milestones Single Site Structure Survey

Eleanor Hewes Kathleen Kirby Karen McCarthy Shau OUTPUT DUE Jane Twitchen RELEASED THIS WEEK 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. 6 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 7 Inspection Preparation Output 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 9 Members of the Group Name Ajitha Gadangi Alina Brezneva Barbara Cano Denise Sturdy Donna Dorozinsky Dorte Frejwald Christiansen

Jackie Morrill Jody Boyles Karen MccarthySchau Karen Roy Kathie Clark ** Chair ** Katie Delaney Laurel-Ann Schrader Linda Rudolph Lisa Pabion Lora Lessing Martin Hausten Melanie Strack Michele Atherton Stacey Jandciu Susan Donahue Company Merck Astellas IDDI Duke Clinical Research Institute Just in Time GCP NNIT Title Associate Director

Manager Central Medical Files Document Management System Specialist Regulatory Intelligence Associate President Principal Consultant LMK Clinical Research BD Paragon Solutions TMF Consultant II Clinical Operations Specialist a Principal Consultant, Life Sciences R&D Practice PhlexGlobal Wingspan Technology Senior Vice President, Client Solutions VP Product Management Infinity Pharmaceuticals Ardea Biosciences Quality Werx, LLC Sanofi Pasteur Shionogi Boehringer-Ingelheim Roche

Purdue Pharma Janssen FHI 360 Clinical Project Manager - Clinical Compliance Supervisor, Clinical Operations Owner/Consultant Quality Systems Project Leader Clinical Trial Associate Team Lead Global Document Specialists / Head of Global Document Quality Center TMF Business Administrator Manager, Records and Systems Manager, TMF Compliance Specialists Director, Clinical Regulatory and Compliance Gathering best practices List of tasks/activities performed to prepare for inspection were listed Roles were also added, but the roles varied a lot between companies Decision was made to develop a RACI that can be adapted to the size and roles of each organisation Inspection Readiness RACI #Task Group

Relevant Relevant Tasks / Process steps for for Paper eTMF? TMF? 1Coordinate TMF x x Clarify studies in scope inspection aspects with with inspector(s) Health Authority 10 Plan the inspection x x Preparing training and other briefing materials for inspectors Key elements Add company specific role

All aspects of access to system, paper documents This could be guidance notes or quick reference guides with screen shots. It could also comprise brief introduction to the TMF process. Finally it could be a roadmap of the TMF content adapted to the trials in scope. Columns added to be used for organisationspecific roles Tasks are grouped to ease overview Indication of whether the task is relevant for eTMF or paper Short description of the actual task or process step Definition of key elements; used to ensure common

understanding of the content of the task eTMF Selection GCP Subteam Overview for the TMF Reference Model Jamie Toth Director, TMF Operations Daiichi Sankyo Inc. Topics Scope Industry Collaboration Team Members Timeline eTMF Selection Categories and Snapshot Next Steps Contact/About Info 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). Industry Collaboration Pocket EDMS announced with draft URS to the public 17-Mar2016 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, SAGGCP was asked to lead this. Steve Scribner and Dimitri Stamatiadis 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 Team Members Name Jamie Toth Russell Joyce Ged Murphy Dimitri Stamatiadis Steve Scribner Jill Johnston Betsy Fallen Martin Thorley Aaron Grant Company Daiichi Sankyo, Inc. Heath Barrowcliff Consulting Glaxo Smith Kline

MAIA Consulting Scribner Group Inc. Veeva BAF Consulting Pfizer PhlexGlobal 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 eTMF Selection Categories Category Access Architecture Audit Trail Business Continuity Document Lifecycle Integration Metadata Naming Convention Permissions Reports

Support System Validatio n Version Control Workflo w Grand Total D 4 6 4 5 5 15 19 1 8 39 106 E 3 2 5 5

3 10 1 13 6 1 2 7 2 18 78 Grand Total 7 8 5 5 7 5 15 1 28 25 2 10 7 2

57 184 15 categories* 184 unique requirements* *As of 05-Jan-2017, may change after Final QC completes eTMF Selection - Snapshot A B C D E F G

E or Desirable D: AEssential Most E have a Regulatory B requirement included In Pocket: If the requirement is also in Pocket EDMS C Pocket URS Reference: D The location of where in Pocket EDMS the requirement resides Category: The category the requirement resides (15) E Description:

F Regulatory Requirement: A full description of the requirement G The reference to the regulation that the requirement may be in Applicable Text: Completed if Regulatory Requirement is filled in 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 Contact Info

Scientific Archivist Group (SAG): and the GCP special interest groups (SIGs) Contact Jamie Toth [email protected] Pocket EDMS: Pocket EDMS documentation can be found at and the discussion forum at Contact Steve Scribner [email protected] or Dimitri Stamatiadis [email protected] 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 TMF RM General Meetings 9-Jan 27-Feb 24-Apr 12-Jun

QUESTIONS? Join the TMF Reference Model Yahoo! Group Knowledge sharing Networking Too Much Fun!

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