Good Clinical Practice (GCP) basics, as FDA enforces them
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human subjects. ICH E6 sets it out. In the United States it is FDA’s regulations that make it enforceable, and FDA checks it by inspection. This guide covers the basics from that end: what each principle asks of a clinical investigator, the regulation FDA holds them to, and how often FDA cites it.
Where GCP comes from, and what binds
ICH E6 is a guideline. FDA has adopted it as guidance, and guidance is a recommendation, not a requirement. What binds a drug or biologic trial in the United States is the Code of Federal Regulations: 21 CFR part 312 (the investigational new drug rules, including the duties of clinical investigators and sponsors), part 50 (informed consent), part 56 (institutional review boards) and part 54 (financial disclosure). When an FDA inspector records a finding, it cites a regulation, almost always one of those, and not ICH E6. The two say largely the same thing; the regulation is the one a finding is written against.
The basics a clinical investigator is held to
Seven principles account for 96% of the findings FDA cites at clinical investigator inspections. The last column is the share of clinical investigator inspections with any finding at which FDA cited that principle, from the FDA inspection record for drug and biologic trials, fiscal years 2009 to 2026.
| Principle | What it asks | Regulation | Cited at |
|---|---|---|---|
| Conduct the study as agreed | Follow the protocol and the investigational plan, and personally conduct or supervise the investigation, as the signed Form FDA 1572 commits. | 21 CFR 312.60 | 81% |
| Obtain informed consent | Obtain legally effective informed consent from each subject before any study procedure, on the IRB-approved form. | 21 CFR 312.60, part 50 | 19% |
| Keep adequate case histories | Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation, for each subject. | 21 CFR 312.62(b) | 48% |
| Control the investigational drug | Administer the drug only to subjects under the clinical investigator’s personal supervision, or that of a subinvestigator responsible to them, and keep records of its disposition: dates, quantity and use by subjects. | 21 CFR 312.61, 312.62(a) | 15% |
| Work under IRB review | Assure initial and continuing IRB review, report changes and unanticipated problems promptly, and make no change without approval except to remove an immediate hazard. | 21 CFR 312.66 | 11% |
| Report to the sponsor | Report adverse events and the progress of the study to the sponsor, and provide a final report and financial disclosure information. | 21 CFR 312.64 | 7% |
| Retain the records | Keep the study records for two years after a marketing application for the drug is approved for the indication studied or, if none is filed or approved, two years after the investigation is discontinued and FDA is notified. | 21 CFR 312.62(c) | 3% |
An inspection can be cited under several principles, so the shares add up to more than 100%. What a failure of each one looks like at a site, the counts behind these shares and how the mix has changed over time: clinical investigator deficiencies.
GCP is not only the clinical investigator’s
The standard assigns duties to every party in a trial. The sponsor must select qualified clinical investigators, give them the information they need, monitor the investigation and act on non-compliance (sponsor responsibilities for clinical investigators). The IRB reviews the research before it begins and keeps reviewing it, with authority to approve it, require changes or disapprove it. FDA inspects all three under one program: FDA inspections of clinical investigators.
Training shows what was taught; the record shows what was done
A GCP training certificate belongs in the site-selection file, and sponsors and CROs collect one as a matter of course. It shows that the clinical investigator was taught the standard. How a site has performed against it is a different question, and where FDA has inspected, the answer is in what FDA recorded: the classification it assigned and each finding it cited, by regulation. Those sit in separate datasets and documents that do not share identifiers; Clinical Precedent assembles them into one record. Reading that record before the Form FDA 1572 is signed is clinical investigator vetting; what the record contains is clinical investigator inspection history.
Questions this page answers
What is Good Clinical Practice (GCP)?
It is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human subjects. ICH E6 sets it out. Following it protects the rights, safety and well-being of trial participants and makes the trial data credible.
Is GCP a legal requirement in the United States?
ICH E6 itself is not. FDA has adopted it as guidance, and guidance is a recommendation. The binding requirements are in the Code of Federal Regulations: 21 CFR part 312 for investigational new drugs, part 50 for informed consent, part 56 for institutional review boards and part 54 for financial disclosure. A finding at an FDA inspection cites a regulation, not ICH E6.
What are the basics of GCP for a clinical investigator?
Seven duties: conduct the study as the protocol and the signed Form FDA 1572 commit; obtain informed consent from every subject before any study procedure; keep adequate and accurate case histories; control the investigational drug and record its disposition; work under IRB review; report to the sponsor; and retain the study records.
How does FDA check that a trial followed GCP?
By inspection, under its Bioresearch Monitoring (BIMO) program. An inspector examines how the site met these duties, and the reviewing center then classifies the inspection NAI, VAI or OAI. What an inspection covers: FDA inspections of clinical investigators.
Does GCP training mean a site is compliant?
No. Training shows that the clinical investigator was taught the standard; it does not show how the site has performed against it. Where FDA has inspected the clinical investigator, the classification and the findings FDA cited are the record of that performance. Where FDA has not, there is no record either way.
Counts are aggregate and carry no identifying information. Related: clinical investigator deficiencies · FDA inspections of clinical investigators · OAI, VAI and NAI · clinical investigator selection · all guides