Good Clinical Practices (GCP) Requirements
GCP Introduction
Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards. It is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance to these standards provides the health authorities as well as the general population with assurance of the integrity of trial subjects and the validity of the data generated.
The US FDA has collaborated and adopted International GCP guidance for the conduct of clinical trials, which have been in effect since the 1970s, addressing both GCP (Good Clinical Practices) and HSP (human subject protection).
Drug GCP Requirements
The ICH-GCP guideline specifies, in rather general terms, how to design, conduct, record and report a clinical trial in accordance with GCP standards. In order to comply with this, it is the responsibility of the sponsor, or sponsor-investigator, to ensure that a set of standard operating procedures is written and that the level and intensity of the GCP monitoring process is specified by the sponsor according to the complexity of the study. Then the monitoring process must be conducted and serves to document that the study complies with GCP standards before the initiation of the study, during the trial and after the trial is completed.
GCP Inspections and Enforcement
FDA maintains information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products. FDA’s bioresearch monitoring (BIMO) program conducts on-site inspections of both clinical and nonclinical studies performed to support research and marketing applications/submissions to the agency. Regulatory correspondence and restrictions can be issued due to noncompliance observed during bioresearch monitoring (BIMO) inspections. The following link provides more information by the FDA about the BIMO program and compliance and enforcement of GCP.
Helpful Resources
FDA regulations and guidance documents related to GCP are accessible through the following links.
- FDA regulation
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- FDA Guidance for Industry
(need links)
- Other education material about cGMP:
Educational Materials
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