The recently enacted U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII, Section 801 mandates the expansion of ClinicalTrials.gov. Specific implications for the Protocol Registration System (PRS) include:

• Several data elements that were previously optional will become required. Generally these elements were already required by ICMJE/WHO policies. These data elements are already identified as required in the PRS.
• A small number of data elements have been added to facilitate full compliance with the new law and to support core ClinicalTrials.gov operations.
• For certain device trials, publication of full registration details will be delayed until clearance or approval of the associated devices is granted by the US FDA. Note that the requirements for registering such trials (e.g., time of initial registration, required data elements) are not affected by this provision.

CAUTION: It is your responsibility to ensure that your registration meets the requirements of applicable laws and regulations. Acceptance by the PRS and assignment of an NCT number to a registration record does not ensure compliance with applicable laws.

Investigators who already have PRS accounts should log into the PRS for the latest information on the changes currently in progress. Others who anticipate needing to register studies in ClinicalTrials.gov in accordance with the new law should request a PRS account using the instructions provided on this web site.

To receive email announcements with updated information about US Public Law 110-85, join the NIH FDAAA Update LISTSERV.

Additional information:

Guidance from NIH Office of Extramural Research:

For specific questions or comments as this relates to the PRS, contact us at register@clinicaltrials.gov.

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