Good Clinical Practice
Meaning of Good Clinical Practice: Two aims in one standard: protect the people taking part, and make the resulting numbers trustworthy enough for a regulator to act on.
Definition of Good Clinical Practice
Good Clinical Practice is an international standard for designing, running, recording and reporting clinical trials that involve human participants. It sets out what sponsors, investigators and ethics committees are each responsible for, with the twin aims of protecting the rights, safety and wellbeing of participants and ensuring the resulting data are credible. It is abbreviated GCP.
What does the standard require?
| Area | What is required |
|---|---|
| Ethics review | An independent committee approves the protocol before anyone is enrolled |
| Consent | Informed consent is given and documented before any trial specific procedure |
| Qualified people | Investigators are trained for the role and the study follows a written protocol |
| Traceable data | Every reported value leads back to an original record that has not been overwritten |
| Safety reporting | Serious events are reported to the sponsor and regulators within set timeframes |
Underneath the paperwork sits a single idea: a person who agrees to take part is owed both protection and honesty, and a result nobody can verify was not worth exposing anyone to. That is why so much of the standard is about records. If a laboratory value in a published table cannot be traced to the original printout, there is no way to tell a transcription slip from an invention.
Where did it come from?
Its ethical spine is older than the document. The principles of voluntary, informed participation and independent review were set out in response to abuses in human experimentation and carried forward in the Declaration of Helsinki. The standard itself was written to solve a practical problem: regulators in different regions each had their own rules, so one clinical trial could not satisfy several at once without duplicating work. A harmonized guideline was agreed between the major regulators and the pharmaceutical industry, and it has since been written into national law and regulation in many countries and revised as trials moved to electronic records and remote monitoring.
How does it differ from similar sounding standards?
Three standards share the Good prefix and cover different ground. Good Laboratory Practice governs nonclinical safety studies done before anything reaches a person. Good Manufacturing Practice governs how the product is made, so what a participant receives matches what the label says. Good Clinical Practice covers the trial itself. Separate again are clinical practice guidelines, which advise how to treat patients in ordinary care and have nothing to do with running a study. Adherence to GCP is normally a condition of using trial data to support approval of a treatment, and inspectors verify it by auditing the records at the sites where the work was done.
Also known as
Used in a sentence
The clinical trial was conducted according to Good Clinical Practice guidelines.
Good to know
Good Clinical Practice governs the conduct of trials involving human participants and is distinct from Good Laboratory Practice, a related but separate standard that applies to preclinical laboratory research.