Good Clinical Practices (GCP)
The Good Clinical Practices are an international quality standard that describes the conditions and processes under which research using clinical subjects (both human and animal) is conducted and that define the roles and responsibilities of clinical trial sponsors, investigators and monitors.
In the US, Clinical Trial research must be conducted in accordance with a series of federal regulations that provide for human subjects protection and privacy and ensures the transparency of human subject research results through the publication of trial information and results on an online registry and results database (ClinicalTrial.gov). [Note: to register as a Study Record Manager (user) at ClinicalTrials.gov, contact the QA.] These regulations have been internationally harmonized through the International Conference on Harmonization (ICH) who has prepared a detailed guidance document for Good Clinical Trials. Additionally, the International Committee of Medical Journal Editors (ICMJE) requires registration of all clinical trials (even non-interventional trials) as a condition of publication.
Additional guidance is also available for laboratories that conducted laboratory analysis in support of a clinical trial which are known as the Good Clinical Laboratory Practices (GCLP). Links can be found on the GCLP page.
GCP Training Opportunities
- Collaborative Institutional Training Initiative (CITI) [For CSU faculty and students only]
- NIH GCP Online Training
- 21 CFR Part 21 – Protection of Privacy
- 21 CFR Part 50 – Protection of Human Subjects
- 21 CFR Part 54 – Financial Disclosure by Clinical Investigators
- 21 CFR Part 56 – Institutional Review Boards
Guidance Documents and Other Resources
- ICH Guidance for Industry E6 (R1) Good Clinical Practice: Consolidated Guidance (March 2018)
- FDA Guidance for Industry Good Clinical Practice (Animal Research; VICH GL9 (85))
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs —Improving Human Subject Protection
Medrio Clinical Trial Software – M-edu is CFR Part 11 compliant software with CloudEDC™ that is FREE for investigator initiated trials.
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