Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards that govern the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. GCP ensures that the rights, safety, and well-being of trial participants are protected, and that the data generated from the trial is reliable and credible. Adherence to GCP is essential for maintaining the integrity and validity of clinical research.
Definitions
ICH E6(R2)
ICH E6 1.24 Good Clinical Practice (GCP):
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected [1].
See also
Links to this page
- Approval (in relation to Institutional Review Boards) (← links)
- Compliance (← links)
- Essential documents (← links)
- GCP (redirect page) (← links)
- Good clinical practice (redirect page) (← links)
- Monitoring (← links)
- Monitoring report (← links)
- Regulatory inspection (← links)
- Sponsor (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
External links
- ICH website, Guideline for good clinical practice E6(R3), https://database.ich.org/sites/default/files/ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf
- ICH website, Good Clinical Practice E6(R3) - Presentation, https://database.ich.org/sites/default/files/ICH_E6(R3)_Step%204_Presentation_2025_0123.pdf