In accordance with Ichilov, Israeli, and international standards, clinical trial audit and overview reviews examine:
- Principal Investigator clinical trial lists
- Standard operating procedure (SOP) compliance
- Research portfolio review (trial documents and origin documents)
- Adherence to participant safety, dignity, rights, and privacy
- Trial document review, including original documentation, study protocol, investigator files, participant informed consent forms etc.
- Accurate side effect reporting
- Conflict of interest assessment (financial and/or ethical)
- Commercial initiative research monitoring (in studies sponsored by a commercial entity)