Good Clinical Practices
Good Clinical Practice (GCP) is an international standard for the conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical and FDA-regulated human subject research. The standards provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of human subjects are protected.
GCP standards are set by the International Council for Harmonisation (ICH). FDA expects implementation of GCP standards for studies generating clinical trial data. NIH expects investigators conducting clinical trials to be trained in GCP standards.
- ICH E6 Guideline for Good Clinical Practice (Basis for GCP Requirements)
- FDA Guidance for Industry: E6 GCP (Expectations for Studies Involving Drugs/Devices)
- NIH Policy on GCP Training for NIH Awardees Involved in NIH-funded Clinical Trials
The following types of human subject research must implement standards of GCP as applicable to the study:
- Studies involving INDs - Investigational New Drugs
- Studies involving SR (Significant Risk) Device IDEs - Investigational Device Exemption
- Studies involving NSR (Non-Significant Risk) Devices
- Studies meeting the NIH Definition of Clinical Trial
Use the links at the top of this page to access GCP Training and the GCP Toolkit.