Every clinical researcher knows, or at least they should, ICH GCP E6 R2 needs to be followed for the conduct of any clinical trial. Even in the device research world, this guideline is used in tandem with ISO 14155. What most researchers are not sufficiently aware of is that this guideline should be read and applied in conjunction with other ICH guidelines relevant to the conduct of clinical trials, namely E2a, E3, E7, E8, E9 and E11 to ensure GCP compliance.
This TRIUM training explains the contents and relevance of ICH guidelines as listed for the day-to-day conduct of a clinical trial. During this 2-hour course real live examples and cases will be shared to ensure proper understanding and readiness for implementation immediately after.
At the end, attendees will receive a certificate and the course hand-outs (in PDF format).
By the end of this TRIUM Training you should be able to:
- Explain the scope and general principles of the guidelines
- List the mandatory elements of a clinical study report
- List the safety measures to be put in place for children and elderly
- Describe the safety reporting cycle and related stakeholders and timelines
- List the different phases of clinical development and related special considerations
- Describe the relevant trial context and trial designs to ensure proper execution of the statistical principles
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.