Essential Records: An Introduction Based on ICH E6(R3)

Essential records—such as protocols, IRB approvals, informed consent forms, Form FDA 1572, and laboratory certifications—play a key role in showing how a clinical trial was conducted and whether it met regulatory expectations.

This course introduces ICH E6(R3) principles and helps build confidence in managing Essential Records using ALCOA-C+–aligned record management practices. Explore how well-managed records support data integrity, effective Trial Master File (TMF) practices, inspection readiness, and risk-based quality management throughout the trial lifecycle.

At the end of this course, participants should be able to:

Explain what Essential Records are and their purpose under ICH E6(R3)
Describe how Essential Records support participant protection and data reliability across the trial lifecycle
Identify how Essential Records are managed before, during, and after trial conduct
Recognize the responsibilities of investigators, CRCs, CRAs, and sponsors in managing and overseeing Essential Records
Describe the purpose and structure of the Trial Master File and its role in inspection readiness
Apply record‑focused thinking to support proactive quality management in clinical trials

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date

​​Essential Records: An Introduction Based on ICH E6(R3)​

​​Essential records—such as protocols, IRB approvals, informed consent forms, Form FDA 1572, and laboratory certifications—play a key role in showing how a clinical trial was conducted and whether it met regulatory expectations.

Essential Records: An Introduction Based on ICH E6(R3)

Essential records—such as protocols, IRB approvals, informed consent forms, Form FDA 1572, and laboratory certifications—play a key role in showing how a clinical trial was conducted and whether it met regulatory expectations.