Clinical Trial Audit & Oversight

Liora Etgar

Director of Clinical Trials & Quality Control

Our Mandate

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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Contact Info

Primary Contact

Liora Etgar
Director of Clinical Trials & Quality Control
Phone. 03-6973195
Email: liorae@tlvmc.gov.il

Information & Resources

Audit & Oversight activities encompass three areas:

  1. Education: Individual training, seminars and courses
  2. Internal audits
  3. 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)

Principal investigator commitment to audit and oversight procedures is critical to clinical trial quality and regulatory adherence.

Audit & Oversight Review Board

Overseeing and evaluating clinical trial protocol compliance.

Prof. Eli Sprecher

Chairman of the Governing Body
Deputy Director of Research, Development & Innovation

Prof. Naftali Stern

Director of Retired Endocrine Institute

Prof. David Seltzer

Director of Clinical Trials Monitoring Unit, Chairman of the Control Body
Director of Internal Medicine

Sigal Ravia

Legal Attorney
Ichilov Legal Advisor

Liora Etgar

Director of Clinical Trials & Quality Control