Good Clinical Practice is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Its core reference is the ICH E6 guideline.
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Good Clinical Practice
noun · clinical research
An international ethical and scientific quality standard for trials involving human participants, protecting their rights and safety and ensuring reliable results.
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In short
Explained
GCP grew out of the Declaration of Helsinki's ethical principles and the need for trial data that regulators in different countries could accept. The ICH E6 guideline, first finalised in 1996, harmonised those expectations. Its revisions added risk-based quality management (R2, 2016) and, with R3, a restructured, principles-based guideline intended to apply across a wider range of trial designs and data sources.
In practice GCP shapes almost everything about how a trial runs: how participants are informed and consent, how investigators are qualified and delegate tasks, how sponsors monitor sites and oversee vendors, how safety events are reported, and how data are recorded, corrected and retained. Our ICH E6(R3) guide covers what changed in the latest revision.
GCP expects computerised systems used in trials to be fit for purpose, with access controls, audit trails that record changes without obscuring the original entry, and procedures for backup and security. Those expectations overlap with electronic records regulations such as FDA 21 CFR Part 11 and EU Annex 11, and with data integrity principles summarised as ALCOA+.
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Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
In Capture
Capture's audit trail records user, time, old value, new value and reason for every field change, is append-only and hash-chained. Electronic signatures re-authenticate the signer and store the meaning. Access follows study and site roles. Capture is built to ICH-GCP E6(R2); GCP compliance also depends on how a trial is run.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Good Clinical Practice.
The ICH guideline that sets out Good Clinical Practice. Its current revision is E6(R3).
GCP is a guideline, but regulators incorporate it into their requirements, so following it is effectively mandatory for trials supporting regulatory submissions.
No. Software provides controls; GCP compliance depends on how the trial is designed, conducted, monitored and documented.
Change a value, sign a form, read the audit trail. Free sandbox.