1. Inspection Preparation 9th January 2017

2. 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

3. 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

4. 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

5. 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