- The document compares the FDA regulations for clinical trials to the International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guidelines. - There are some differences between the two, such as ICH requiring more documentation of trial procedures and delegation of duties, while FDA regulations are less specific. - Overall ICH GCP guidelines facilitate international harmonization and acceptance of clinical trial data between the US, EU, and Japan. Compliance with ICH GCP helps assure rights and safety of trial subjects.

1. Where the FDA Regulations End and ICH GCP Begins The Differences & Similarities Between the Two Paul Below, CCRA GCP Trainer Medical Research Management, Inc. SoCRA 16 th Annual Conference Adams Mark Hotel, Denver, CO September 29, 2007

15. Specific Differences Between ICH GCP and the FDA Regulations