Good Clinical Practice (GCP)

Its rules cover almost every part of a trial. Each study needs an approved protocol and independent ethics review, and every participant must give informed consent before taking part. Sponsors, investigators and monitors have defined duties. Staff must be qualified, investigational products must be handled and accounted for, and data must be recorded accurately, kept traceable and protected. Monitors check trial sites against source records and auditors may follow. Serious safety events are reported within set times. The most widely used version is the guideline from the International Council for Harmonisation, and many regulators require it for trial data used in a marketing application. Breaches such as missing consent or altered records can lead to rejected data, trial suspension or sanctions. Regulators weigh trial data against GCP before accepting it, and a site that cannot show consent and source records risks losing its results.

A pharmaceutical sponsor runs a trial at 20 hospitals. A monitor visiting one site finds that three participants signed consent forms after their first study procedure. The site records the deviation, retrains staff and reports to the ethics committee. The sponsor decides whether to include those participants' data and discloses the deviation to the regulator in the trial report.