Good Clinical Practice

Good Clinical Practice is the international ethical and scientific standard for designing, conducting, recording, and reporting trials that involve human subjects (ICH E6). It protects the rights, safety, and wellbeing of participants and ensures the credibility of the data a trial produces — the two goals on which every marketing application ultimately rests.

Unreliable trial data can put participants at risk and sink a submission years and hundreds of millions of dollars in. Informed-consent and source-data findings are among the most common FDA and EMA inspection citations, and a serious GCP breach can invalidate a pivotal study outright. GCP is where patient protection and data credibility are won or lost.

IRB/IEC oversight, a properly executed and documented informed-consent process, and the ethical safeguards that keep participant welfare ahead of the science.

Clearly delineated duties — the investigator’s conduct of the trial at site and the sponsor’s oversight, safety reporting, and quality management of the whole programme.

Source documents and the case report form linked by an intact, contemporaneous data trail, so a monitor or inspector can reconstruct exactly what happened to each subject.

A quality-by-design, risk-based approach (ICH E6(R2/R3)) that focuses monitoring and oversight on what matters most to subject safety and data reliability.

• ›Informed-consent process and documentation (versions, dates, re-consent)
• ›Protocol deviations and how they were identified, reported, and managed
• ›Source-data verification against the case report form
• ›Investigational product accountability and handling

Derived from the 7 standards SPEQ decodes for this discipline.