1. Computerized Systems in Clinical Research
Current Quality and Data Integrity Concepts
Computerized Systems in Clinical Research

2. Agenda Red Apple Background “Peach” Objectives When, Where, What
Application
Current Table of Contents
Chapter Chairs – Roles/Responsibilities
Participants – Roles/Responsibilities
Questions

3. Red Apple Background
Original Red Apple in 1987 to create a resource for validation and best practices involving GLP computerized systems.
In 2006 a group convened in PA to update and add to the original document.
Release of this resource is eminent!
(purchasing through DIA in March)

4. “Peach”
During the Red Apple process, the idea was raised to create similar resources in other areas starting with the GCP area. The concept was approved by DIA at the annual meeting in Atlanta in Hence the nickname “Peach”

5. Objectives
Develop the awareness and the skills to build quality and data integrity into computer systems used in clinical research
Develop a practical and useful reference for technical, clinical research, clinical laboratory and management personnel who design, test, use, support and manage computerized systems used in clinical research.

6. When, Where, What Date: Sept. 8-12, 2008 Location: Horsham, PA
Objective: Draft resource manual
May involve some preparatory teleconferences and meetings
Definitely will involve subsequent document review

7. Application Global Participants sought Questionnaire located at:

8. Current Table of Contents
Chapter 1 – Purpose
Chapter 2 – Stakeholders
Chapter 3 – Data Integrity & Quality
Chapter 4 – Clinical Research
Chapter 5 – Clinical Data Integrity
Chapter 6 – The Systems Life Cycle and Computer System Validation
Chapter 7 – Quality in Clinical Research
Chapter 8 – Risk in Clinical Research
Chapter 9 – Computer System Validation in Clinical Trials
Chapter 10 –Computer System Validation and Clinical Records, Record Retention
Chapter 11 – Programming Languages and other Related Software
Chapter 12 – Building Quality into Clinical Research: Quality Control and Quality Assurance

9. Current Table of Contents
Chapter 13 – Practical Risk Assessment in Clinical Computer Systems
Chapter 14 – Impact of Computer System Validation on Data Integrity
Chapter 15 – Infrastructure
Chapter 16 – Security
Chapter 17 – Outsourcing
Chapter 18 – Data Collection Techniques, Tools and Source Data
Chapter 19 – Medical Diagnostic Equipment
Chapter 20 – Bioanalytical & Central Laboratories
Appendix A – Glossary
Appendix B – References
Appendix C – Bibliography of Regulations, Directives and Guidelines 9

10. Chapter Chairs
Schedule conference calls prior to the workshop to discuss plans
Provide reference materials to participants
Prepare list of thought provoking questions to focus the chapter’s objectives on current best practices and challenges for technology
Manage Meeting Times
Establish schedules for Discussion, Presentation of Topics, Group Feedbacks, and Writing
Limit discussion to specific chapter and objectives
Concentrate on content—a professional medical writer has been hired to edit the chapters
Maintain a “Parking Lot” list of ideas and concepts that are outside the objectives and goals of this project.

11. Participants Critically review and comment on the materials provided
Focus on the assigned session
Bring reference materials as instructed
Assist in generating outline and draft text for chapter
Be prepared to work and learn!

12. Questions?