Master the global standard for ethical, high-quality clinical trials and prove it with an industry-recognized certificate.
one-time · lifetime
Good Clinical Practice (GCP) is the international ethical and scientific quality standard that governs how human clinical trials are designed, conducted, recorded, and reported. This course teaches the ICH E6(R2) guideline the way it is actually applied on live studies, so you can walk onto a site, a sponsor team, or a CRO and speak the language of compliance from day one.
Across four focused modules you will build a complete working knowledge of GCP: the ethical foundations that shaped it, the exact responsibilities of sponsors, investigators, monitors and ethics committees, the mechanics of informed consent, safety reporting and data integrity, and the modern R2 additions covering quality by design, risk-based monitoring and vendor oversight. Every lesson is written for real-world use, with practical examples, checklists and the terminology inspectors expect to hear.
The course is fully self-paced and online. Short quizzes at the end of modules 2, 3 and 4 reinforce each topic, and a 10-question final exam confirms your mastery of the whole guideline. Pass the final assessment and you earn an industry-recognized ICH-GCP E6(R2) certificate you can add to your CV, LinkedIn profile and regulatory training file.
Foundations of GCP, What Good Clinical Practice is, the ethical scandals and landmark documents that created it, and the 13 core principles that hold every trial together.
Roles and Responsibilities, Who does what on a clinical trial: the sponsor, the investigator and their delegated team, the monitor or CRA, and the independent ethics committee.
Informed Consent, Safety and Data Integrity, The informed consent process and its required elements, the classification and reporting of adverse events, and the documents and data-quality standards that make a trial verifiable.
Quality Management in R2, The R2 addenda that modernised GCP: quality by design, risk-based quality management and monitoring, sponsor oversight of vendors and CROs, and the control of computerised systems and electronic data.
The Ethical History Behind GCP
Locked
The 13 Principles of ICH-GCP
Locked
The Sponsor
Locked
The Investigator and Delegation
Locked
The Monitor, the CRA and the Ethics Committee
Locked
The Informed Consent Process
Locked
Adverse Events and Safety Reporting
Locked
Source Data, Essential Documents and ALCOA+
Locked
Quality by Design and Risk-Based Quality Management
Locked
Risk-Based Monitoring and Sponsor Oversight of Vendors
Locked
Computerised Systems and Electronic Data
Locked
4 modules · 12 lessons · Preview lessons are free to read; enroll to unlock the full course.
Clins Research Academy
Clins Research Pvt Ltd is a Clinical Research Site Management Organization (SMO) based in Gurugram. Our courses are designed and delivered by practitioners with hands-on experience across the clinical trial lifecycle.
