The international quality standard for clinical trials — for investigators, CRCs, CRAs and research staff.
one-time · lifetime
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human participants. A GCP certificate is the baseline credential expected of everyone who works on a trial.
This program teaches the current ICH-GCP E6(R3) framework end to end: the ethical foundations, the responsibilities of every party, the informed-consent process, safety reporting, data integrity (ALCOA+), and how sites stay inspection-ready. Each module ends with a check, and a final exam unlocks your certificate.
By the end you will be able to explain the 13 GCP principles, identify who is accountable for what, run a compliant consent process, classify and report adverse events correctly, and recognise the documents an auditor will ask for.
Foundations of GCP & Research Ethics, Why GCP exists, the ethical milestones behind it, and the principles that govern every trial.
The Trial Framework & Essential Documents, The parties on a trial, the documents that define it, and the files that prove it happened.
Investigator & Site Responsibilities, What the PI is accountable for, how tasks are delegated, and how the investigational product is controlled.
Protecting Participants & Informed Consent, Running a valid, voluntary consent process and protecting vulnerable participants and their data.
Safety Reporting & Data Integrity, Classifying and reporting adverse events, and keeping data ALCOA+ compliant under E6(R3).
Monitoring, Inspections & Closeout, How trials are checked, how non-compliance is handled with CAPA, and how a trial ends.
The ethical milestones behind GCP
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The principles of ICH-GCP
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Who's who: sponsor, CRO, investigator, EC
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The protocol, IB and amendments
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Essential documents: TMF and ISF
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PI accountability and delegation
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Training, oversight and the delegation log
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Investigational product accountability
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The informed consent process
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Vulnerable participants
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Confidentiality and data protection
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Adverse events: AE, SAE and SUSAR
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Data integrity and ALCOA+
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Quality by design & risk-based thinking (E6 R3)
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Monitoring, audits and inspections
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Non-compliance and CAPA
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Trial closeout and record retention
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6 modules · 18 lessons · Preview lessons are free to read; enroll to unlock the full course.
Clins Research Training Academy
Clins Research Pvt Ltd is a Clinical Research Site Management Organization (SMO) based in Greater Noida. Our courses are designed and delivered by practitioners with hands-on experience across the clinical trial lifecycle.
