Accelerating Product Development May 15, 2014 IMDMC Reg 101. IDEs (Investigational Device Exemptions) Clinical Trials IRBs (Institutional Review Boards). What we will cover today. 21 CFR 50 Protection of Human Subjects 21 CFR 54 Financial Disclosure
Accelerating Product Development
May 15, 2014
IMDMC Reg 101
If not exempt:
Individual, company, institution or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial
Person responsible for the conduct of a clinical trial at a trial site
A board, committee, or other group formally designated by an institution to review, approve the initiation of and conduct periodic review of biomedical research involving human subjects.