Office of Clinical Research

Clinical Trials Regulatory Guidance

The Office of Clinical Research (OCR) provides regulatory guidance to Principal Investigators and their research personnel. Guidance is available for a host of regulatory concerns including:

  • IND/IDE requirements
  • Informed consent document requirements
  • IRB and FDA submission requirements
  • Adverse event and unanticipated problem reporting requirements
  • Regulatory binder maintenance requirements
  • CT.Gov Database Access and guidance - Protocol Registration and Results System (PRS) was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug (IND) applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.

The registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials. This led to the development of the results database, which contains information on study participants and a summary of study outcomes, including adverse events. The results database was made available to the public in September 2008. FDAAA 801 also established penalties for failing to register or submit the results of trials.

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CRC Submission Guidance
IRB Submission
FDA Clinical Trials Guidance Documents
Investigational New Drug Application Template
Investigational New Drug Annual Report Template
Investigational Device Guidance
Essential Documents and Recommended Templates
Clinical Trial Related Policies