Chair: Arthur S. (Art) Zbrozek RPh, MSc, MBA, Senior Director, Health Care Relations, Field Economics Team, AstraZeneca Pharmaceuticals, Wilmington, DE, USA

Objective: 
To develop a non-technical guide for clinical trial sponsor use on the requirements and documentation needed from a data collection systems vendor / manufacturer to demonstrate systems validation

The deliverable is expected to be a short, (~ 4-page) paper that will provide a practical and user-friendly source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services:

1. operate reliably when in practical use
2. produce accurate and complete data and data files
3. support management control
4. improve sponsor confidence
5. comply with any existing regulations.

Leadership Members:
Thomas Atkinson PhD, Postdoctoral Research Fellow, Memorial Sloan-Kettering Cancer Center, NYC, NY, USA
Ethan Basch MD, MSc, Attending Physician and Outcomes Researcher, Memorial Sloan-Kettering Cancer Center,
New York, NY, USA
Alexandra Brentani PhD, Executive Director, Western Region Project, Faculdade de Medicina da USP, Sao Paulo, Brazil
Chih-Hung Chang PhD, Associate Professor, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA
*Christopher Dell, Pfizer, Ltd.
Mario Donoso BA, Procurement & Logistics, Arrowhead Electronic Healthcare, Austin, TX, USA
*Gregory Gogates BS, VP Regulatory Affairs, CRF Inc., Lansdale, PA, USA
Alison Greene MPH, Principal, PRO, Hoffman-La Roche, Inc., Nutley, NJ, USA
*Joy Hebert BA, Chief Operating Officer, .assisTek, Scottsdale, AZ, USA
*Sheldon Hines, Pfizer, Ltd.
Sandra Kane-Gill MS, PharmD, BSc, Associate Professor, University of Pittsburgh, Pittsburgh, PA, USA
*Scottie Kern BSc, Assoc Director, Pfizer, Ltd, Taplow, England, UK
Smita Kothari PhD, RPh, MBA, Senior Manager, HEOR Astellas Pharma US, Deerfield, IL, USA
Wilhelm Muhlhausen, Senior Product Manager, CareFusion Research Services, Nenagh, Ireland
*Raymond Panas PhD, BS, MPH, Assistant Professor George Washington University Washington DC USA
*Jean Paty PhD, Chief Scientific and Regulatory Advisor, PRO Consulting Division, invivodata, inc., Pittsburgh, PA, USA
Marwan Shouery MS, Senior Programmer & Analyst, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Jun Su MD, Associate Director, Boehringer Ingelheim Pharmacuital, Inc., Ridgefield, CT, USA
*Rod Thorell, Director, Quality & Compliance, PHT Corp, Charlestown, MA, USA
Tarun Wadhwa MPH, Senior Research Fellow, Belgaum, India
Wade Whitmer BA, President, OurHealthData, Addison, TX, USA

Methodology:

1. Review - completed
1. System validation and implementation best practices literature
2. FDA regulations and guidance documents
   
2. Recruit expert team* of highly experienced ePRO providers – completed
   
3. Develop outline for deliverable – underway
    
   I. Basic validation principles and evidence
1. Section on minimum validation elements within the context of data risk
2. Section on standards that exist per each element
3. Considerations that should be given relative to the risk of the data collected 

          II. Guidelines for appropriate evidence of software configuration to end-user systems.

          Note: Important elements to remember for the document
                  a. There is no single, accepted validation method by the FDA
                  b. We plan to avoid references to auditing and GAMP standards since our document is for up-front
                       decisions, not justifying effort results downstream to auditors.

Please contact the ISPOR Staff Liaison, Elizabeth Molsen RN, (emolsen@ispor.org) if you would like to become an active member of this project team.