Clinical trials are conducted in conformance with (i) the Protocol, (ii) all applicable laws and regulations, including without limitation, the Ministry of Health (MOH) Guidelines No. 14 entitled: “Conduct of clinical trials in human subjects,” (iii) the relevant ethics committee’s (EC) approval for the study and (iv) ICH GCP guidelines for good clinical practice. Before the commencement of the study, the sponsor shall be responsible for obtaining HMO’s ethics committee approval and/or MOH approval, as required by law. The investigator shall obtain the signed informed consent form (ICF) from each subject before participating in the study. A quality assurance committee operates in Hadassah and performs internal audits to verify compliance with law and regulations for sponsored and investigator-initiated studies.
