Good Clinical Practices (cGCP)

Investigator Oversight of Clinical Trials

Through a compelling narrative involving fictional Dr. Silva, learners will navigate the challenging world of Investigator oversight under the updated ICH E6(R3) Good Clinical Practice guidelines. They’ll learn about investigator oversight while the trial is active as well as how it extends beyond the final patient until the trial dataset is locked.

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CEU Credits: 0.1
Course Code: ELM-999
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 12/05/2025

Curriculum for this course

Course Introduction
During the trial
Delegation and oversight
Participant safety and informed consent
Protocol deviation management
IP accountability and use
Data integrity and records management
Computerized system governance
The end of the trial
Trial termination or suspension
End of participant involvement
Final reporting
Records retention and control
Final data endorsement
Summary
Test Your Knowledge
v1.0 Course released on 01/27/2026

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