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

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

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)

“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 2007. Hence the nickname “Peach”

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.

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

Application Global Participants sought Questionnaire located at: http://www.zoomerang.com/survey.zgi?p=WEB2273JL7CLMR

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

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

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.

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!

Questions?