- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical PracticeCenter for Drug Evaluation and Research
This guidance is intended to clarify IRBs' responsibilities for reviewing the qualifications of investigators, determining the adequacy of research sites, and determining whether an investigational new drug application (IND) or investigational device exemption (IDE) is needed. Although these activities are viewed primarily as sponsor responsibilities, FDA encourages all parties—IRBs, clinical investigators, and sponsors—to work together in order to protect the rights and welfare of study subjects.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0847.