Good Clinical Practice (GCP)
In Good Clinical Practice & ethics
Also known as: GCP guidelines
Good Clinical Practice (GCP) is the international quality standard for designing, running, recording, and reporting clinical trials in people. It exists to do two things at once: protect the rights, safety, and wellbeing of participants, and make sure the data a trial produces can be trusted. The main global reference is the ICH E6 guideline, which regulators around the world have adopted into their own rules.
| Principle | In short |
|---|---|
| 1 | Ethical conduct, rooted in the Declaration of Helsinki. Participants' rights, safety and well-being come first. |
| 2 | Informed consent is integral to an ethical trial. |
| 3 | Independent review by an IRB or IEC. |
| 4 | Trials are scientifically sound for their purpose. |
| 5 | Trials are designed and run by qualified people. |
| 6 | Quality is built into the design and conduct. |
| 7 | Processes are proportionate to the risks and to the importance of the data. |
| 8 | A clear, concise, scientifically sound and operationally feasible protocol. |
| 9 | Trials generate reliable results, with records kept for the required period. |
| 10 | Roles and responsibilities are clear and documented. |
| 11 | Investigational products are made to applicable GMP standards and managed per the protocol. |
Where the rule comes from
ICH E6(R3), adopted on 6 January 2025, states these principles in Section II. GCP compliance means a trial is run in line with them, with the approved protocol and with the regulations that apply, and that the records can show it. The Annex 1 sections then set out the duties of the ethics committee (section 1), the investigator (section 2) and the sponsor (section 3).
Why it matters
GCP training is the single most common requirement on entry-level clinical-research job adverts. Almost every task on a trial (consenting a participant, correcting a record, reporting a side effect) traces back to a GCP principle.
Example
A coordinator notices a consent form was signed a day after the first study blood draw. Under GCP, no study procedure may happen before consent, so this is documented as a deviation and reported to the sponsor and the ethics committee.
Common questions
- Do you have to pay for GCP training?
- No. Several widely recognized providers offer GCP training free to learners, and many employers run their own GCP onboarding regardless of what you arrive with. What matters in an interview is whether you can reason with GCP, not which certificate you hold.
- How long is GCP certification valid?
- There is no single global expiry. Many sponsors and sites ask for refresher training every two to three years, and some require their own in-house version on top of an external certificate.
Related terms
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Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.