Guidelines for Clinical Trials in Human Subjects - 2006 English临床试验在人类受试者的英语指南2006.pdf

Ministry of Health Pharmaceutical Administration Jerusalem Guidelines for Clinical Trials in Human Subjects In accordance with the Public Health Regulations (Clinical Trials in Human Subjects) 1980 2006 Procedure title: Guidelines for Clinical Trials in Human Subjects Date: January 2006 Procedure number: 14 Page 4 of 44 Table of contents General 6 Definitions 6 Contents of the guidelines 10 1. Conditions for the conduct of a clinical trial in human subjects 10 2. Contents of the application for a clinical trial 11 2.1 Application form. 11 2.2 Detailed plan for the clinical trial (trial protocol) 11 2.3 Investigator’s Brochure (IB) 13 2.4 Certificate of analysis from a recognized laboratory 18 2.5 Informed consent form. 18 2.6 Sponsor’s statement of commitment 18 2.7 Declaration of Sponsor or Sponsors representative in Israel (Form 5) 19 2.8 Document checklist 19 2.9 Notice for enrollment of participants 19 2.10 Letter to the attending HMO physician 19 3. Informed consent procedure 19 4. Rules for the approval of clinical trial applications 22 5. Authorities of the Director of a medical institution 22 6. Special clinical trials and special amendments which the Director of the medical institution is authorized to approve without additional approval by the Ministry of Health 23 6.1 Medicinal products (including biological products) 23 6.2 Medical devices and instruments/medical equipment 23 6.3 Miscellaneous