Info & Register – Download the Agenda – Speaker’s Bios
October 23, 2018:
Welcome David Burrow Keynote Robert Temple |
Dr. Temple’s Slides View Recording |
Session 1 – Data Integrity from International Perspectives | |
Background and Purpose of Collaboration Ni Khin Gail Francis |
Slides in ZIP file above View Recording |
Quality Management System/Quality by Design (QMS/QbD) Jean Mulinde |
Slides in ZIP file above View Recording |
Overview of Data Integrity Gail Francis |
Slides in ZIP file above View Recording |
Good Clinical Practice Assessment of Data Reliability in Registration Trials Kassa Ayalew |
Slides in ZIP file above View Recording |
Session 2 – Data Management | |
Control and Quality of Clinical Data Andy Fisher |
Slides in ZIP file above View Recording |
The Data Management Plan – Pulling It All Together Cynthia Kleppinger |
Slides in ZIP file above View Recording |
Morning Q&A and Panel Discussion was postponed Morning Speakers |
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Session 3 – Controlling Bias: The Study Blind | |
Unblinding – Let Me Count the Ways Gail Francis Jean Mulinde |
Slides in ZIP file above View Recording |
Blinding of Bioequivalence Trials Seongeun (Julia) Cho |
Slides in ZIP file above View Recording |
Session 4 – Know Your Audit Trails | |
Design and Effective Use of Audit Trails Stephen Vinter |
Slides in ZIP file above View Recording |
A Case Example of the Review of Audit Trails in GCP Inspections Phillip Kronstein |
Slides in ZIP file above View Recording |
Afternoon Q&A and Panel Discussion Afternoon Speakers |
View Recording |
October 24, 2018:
Day Two of the Workshop consisted of the in-person participants working in small groups on four case studies. It was NOT recorded. However, the materials used for the four case studies can be downloaded here:
- Case Study 1: Vendor Selection
- Case Study 2: Unblinding
- Case Study 3: Audit Trail
- Case Study 4: Data Management