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Resources
The following are a list of resources that may be helpful in the conduct of your research study.
FDA
Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection
Guidance for Industry: Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions – IRB Registration
FDA Code of Federal Regulations
FDA 510K Device Premarket Notification
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies
Search OHRP/FDA Database for Registered IRBs and Approved FWAs
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure
DHHS/OHRP
Department of Health and Human Services Part 46: Protection of Human Subjects
OHRP Frequently Asked Questions
OHRP Guidance Documents
EPA
EPA Code of Federal regulations
ICH
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
Note:
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