How to avoid common Good Clinical Practice-related data integrity issues
This talk will inform clinical study team personnel on how to avoid data integrity problems through quality set up and management of the clinical research process. The talk incorporates the 13 principles of Good Clinical Practice (GCP) and their application to real audit findings from various FDA warning letters.
GCP is an international ethical and scientific quality standard for the design, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Deviating from GCP can impact the quality of data, jeopardize subject safety and render the study unusable.
Lois Mannon, Director of Research Enterprise Training
- Monday, July 23, 2018
- 10:00am - 11:30am
- Lapidus Library Classroom G101