GCP: A Question & Answer Reference Guide Submission Documents Required for Local EC Submission Submission Document Study Type Clinical trial with medicinal product Clinical trial with medical device Clinical trial with advanced therapy medicinal product Genetic clinical trial Clinical trial with no investigational product Combined trial Registry and questionaire studies Protocol √ √ √ √ √ √ √ √ √ √ IB Investigational Medicinal Product Dossier (IMPD) For each product √ √ √ √ √ √ √ √ 1A 1B 1C 1D 1E Several forms 1F ICF - participant (2) 2A 2B 2C 2D 2E 2 2F ICF - guardian (3) 3A 3B 3C 3D 3E 3 3F Sponsor's statement of 4A 4B 4C 4D 4E 4 5 5 5 5 5 5 Document checklist (9) 9 9 9 9 9 9 9 Notice for enrolment (10) 10 10 10 10 10 10 10 Letter to physician (11) 11 11 11 Relevant literature Application form (1) commitment (4) Sponsor's declaration on documents (5) 6 11 Q. How long does it take to approve a clinical trial in Israel? A. The timelines are not defined in the MoH guidelines, and this depends on whether or not the trial is considered "special." Based on experience, the following timelines are to be expected: * Most of the ECs require a full submission package to be handed in within 3 weeks prior to the EC's meeting. The ECs specify a deadline date for the submission, while in some institutions, a set number of trials is discussed in each EC meeting the submitted trial's participation in a meeting is subject to availability of slots * The EC gives its decision within approximately 2 weeks and if no changes to the submission are required, the final approval is granted within another 2 weeks, provided that the CTA, insurance policy and NIH registration are in place. It is therefore highly recommended not to wait for the EC's approval before beginning negotiations on the CTA and dealing with the insurance and NIH study registration. 688