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Good Clinical Practice (GCP)
Good clinical practice is an ethical and quality standard that follows the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It enforces regulations for the designing, conducting, monitoring, auditing, recording, analysis, and reporting of clinical trials that involve the participation of human subjects. All investigators and their staff are expected to comply with Good Clinical Practice.
The purpose of the regulations in Good Clinical Practice is to protect the safety, rights, and welfare of the human subjects, as well as ensure the integrity of the data obtained through clinical trials conducted in accordance with approved plans.
The GCP provides guidance on the requirements and responsibilities of the IRBs, investigator, and sponsor, as well as the requirements for the clinical trial protocol and investigator’s brochure.
Source: Good Clinical Practice. (2019, December 11). U.S. Food and Drug Administration. Retrieved January 8, 2022, from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/good-clinical-practice