Investigational Trials Resource
ITR Policies
Program Site Committee
- Program Site Committee Membership Policy
- Program Site Committee Review Policy (updated 5/18/11)
Protocol Review Committee
- Protocol Review Committee Membership Policy (updated 8/19/11)
- Protocol Review Committee Review Policy
- Amendment Submission Policy
- Amendment Review Policy
- Protocol Closure Policy
Study Conduct
- Processing IND Safety Reports and Other Safety Reporting Information
- Policy for Obtaining Informed Consent * updated version
- FDA Inspections Guidance
- Risk Notification Policy (updated 1/17/12)
Policy Summary of Changes
- Summary of Changes (April 2011)
- Summary of Changes (July 2011)
