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 is a first in a series of ICH guidelines training, starting with explaining the contents and relevance of ICH guidelines E2a (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E8 (general Considerations for Clinical Trials) and E9 (Statistical Principles for Clinical Trials) for the day-to-day conduct of a clinical trial. You will learn the safety reporting cycle from site to sponsor to regulatory bodies back to the site; including expedited reporting, the different development methodologies and trial phases and their rationale and the different types of trial designs, statistical principles and related relevant trial context, amongst others. This training is intended to ensure proper understanding of your impact as researchers on the safety reporting and statistics, rather than a training on the execution of statistical analysis.
Real live examples and cases will be shared to ensure proper understanding and readiness for implementation immediately after.
By the end of this TRIUM Training you should be able to:
- Explain the scope and general principles of the E2a, E8 and E9 guidelines
- 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.