Inspection Preparation 9th January 2017

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

Members of the Group Name Company Title Ajitha Gadangi Merck Associate Director Alina Brezneva Astellas Manager Central Medical Files Barbara Cano IDDI Document Management System Specialist Denise Sturdy Duke Clinical Research Institute Regulatory Intelligence Associate Donna Dorozinsky Just in Time GCP President Dorte Frejwald Christiansen NNIT Principal Consultant Jackie Morrill LMK Clinical Research TMF Consultant II Jody Boyles BD Clinical Operations Specialist a Karen Mccarthy-Schau Paragon Solutions Principal Consultant, Life Sciences R&D Practice Karen Roy PhlexGlobal Senior Vice President, Client Solutions Kathie Clark ** Chair ** Wingspan Technology VP Product Management Katie Delaney Infinity Pharmaceuticals Clinical Project Manager - Clinical Compliance Laurel-Ann Schrader Ardea Biosciences Supervisor, Clinical Operations Linda Rudolph Quality Werx, LLC Owner/Consultant Lisa Pabion Sanofi Pasteur Quality Systems Project Leader Lora Lessing Shionogi Clinical Trial Associate Martin Hausten Boehringer-Ingelheim Team Lead Global Document Specialists / Head of Global Document Quality Center Melanie Strack Roche TMF Business Administrator Michele Atherton Purdue Pharma Manager, Records and Systems Stacey Jandciu Janssen Manager, TMF Compliance Specialists Susan Donahue FHI 360 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 for Paper TMF? Relevant for eTMF? Tasks / Process steps Key elements Add company specific role 1 Coordinate TMF inspection aspects with Health Authority x Clarify studies in scope with inspector(s) All aspects of access to system, paper documents   10 Plan the inspection Preparing training and other briefing materials for inspectors 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 organisation-specific roles Tasks are grouped to ease overview Definition of key elements; used to ensure common understanding of the content of the task Short description of the actual task or process step Indication of whether the task is relevant for eTMF or paper