IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf