comprehensive, self-paced Good Clinical Practice course aligned to ICH E6(R3) (2025). Across twelve modules and a final examination it covers the GCP principles, investigator and sponsor responsibilities, participant safety, informed consent, data governance and trial oversight — meeting and exceeding the TransCelerate minimum criteria for GCP investigator site personnel training. Approximately 16 hours of self-paced study.
This course provides foundational training in Good Clinical Practice (GCP), the international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human participants.
Grounded in the principles of ICH E6(R3), the training covers the responsibilities that protect the rights, safety, and well-being of trial participants and ensure the credibility of clinical trial data. Participants will work through the core areas of GCP, including the ethical foundations of clinical research, the roles and responsibilities of investigators, sponsors, and ethics committees, the informed consent process, safety reporting, investigational product handling, essential documents and the trial master file, and the principles of data integrity.
The course combines clear learning materials with short assessments to reinforce understanding. On completion of all modules and a successful pass in the final assessment, participants receive a certificate recording their achievement.
This training is suitable for clinical research professionals across all roles, including investigators, study coordinators, research nurses, and site staff, whether new to clinical research or seeking to refresh existing knowledge to remain current with prevailing standards.