In accordance with national and international ethical, safety, and quality standards, Ichilov’s office of Audit & Oversight evaluates all clinical trials conducted by and in collaboration with Ichilov Hospital while enforcing Ministry of Health Supervision and Control operational procedures.
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Audit & Oversight activities encompass three areas:
- Education: Individual training, seminars and courses
- Internal audits
- External audits
- The Ministry of Health’s Control Unit
- The JCI Organization
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)
Audit & Oversight Review Board
Overseeing and evaluating clinical trial protocol compliance.
David Zeltser Prof
Naftali Stern, Prof
Daphne Peri-Sharon
Ortal Bitan
Gali Hagler Price -