1. Committee is appropriately composed (i.e., nonaffiliated, nonscientist, scientist, organization representative, and at least five members) |
Nonaffiliated member |
Scientist |
Nonscientist |
Organization representative |
Consumer or community representative |
Other |
2. Training |
Functions, processes, and procedures of a review committee |
Organization specific |
Local state law |
3. Written procedures or information developed for each item |
Review types |
Exempt |
Expedited |
Full |
Submission instructions |
Informed consent process |
Approval timeline and criteria |
Protocol changes |
Audit and record retention |