1. Module C FDA Regulations Regulatory Documents Patricia E. Koziol 1Module C Final Version 10-apr-2010

2. Food and Drug Administration www.fda.gov 1906 – Food and Drug Act CBER – Center for Biologics Evaluation and Research CDER – Center for Drug Evaluation and Research CDRH – Center for Devices and Radiological Health 2Module C Final Version 10-apr-2010

3. Institutional Review Boards 21 CFR Part 56 Sec. 56.107 – Membership. Sec. 56.108 – IRB functions and operations. Sec. 56.115 – IRB records. Sec. 56.121 – Disqualification of an IRB or an institution. Sec. 56.123 – Reinstatement of an IRB or an institution. 3Module C Final Version 10-apr-2010

4. Protection of Human Subjects 21 CFR Part 50 Sec. 50.20 – General requirements for informed consent. Sec. 50.23 – Exception from general requirements. Sec. 50.24 – Exception from informed consent requirements for emergency use. 4Module C Final Version 10-apr-2010

5. Protection of Human Subjects 21 CFR Part 50 Sec. 50.25 – Elements of informed consent. Sec. 50.27 – Documentation of informed consent. 5Module C Final Version 10-apr-2010

6. Standard Operating Procedures SOPs Detailed, written instructions to achieve uniformity of the performance of a specific function. Ref. Good Clinical Practice: Consolidated Guideline, Glossary. Module C Final Version 10-apr-20106

7. Clinical Quality Assurance Sponsor The Sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). Ref. Guideline for Good Clinical Practice: Consolidated Guideline, Sec. 5.1. Module C Final Version 10-apr-20107

8. Clinical Quality Assurance Site The investigator should ensure that all persons assisting with the trail are adequately informed about the protocol, the investigational product(s), and their trial- related duties and functions. Ref. Good Clinical Practice: Consolidated Guideline, Sec. 4.24. Module C Final Version 10-apr-20108