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Protocol Registration System (Logo) Federal Sponsors' Logos: DHHS, NIH, FDA

Protocol Registration System Information provides current information about clinical research in human volunteers. The Protocol Registration System (PRS) is a Web-based tool developed for submitting information to

1. Take the PRS guided tour

2. Frequently Asked Questions

3. Apply for a PRS account

A PRS account is required for submitting study information to Trial data may be submitted by the following entities:

  1. Sponsors legally responsible for conducting clinical trials, e.g., holders of investigational new drug applications from the U.S. Food and Drug Administration.
  2. Governmental or international agencies conducting or supporting clinical trials, e.g., the U.S. National Institutes of Health.
  3. Lead principal investigators who are responsible for conducting and coordinating the overall clinical investigation across multiple study sites. Trial data should not be submitted from each individual study location.

All studies submitted to must have approval from a human subjects review board, such as an Institutional Review Board, ethics committee, or equivalent group, that is responsible for reviewing and monitoring human subjects in this protocol.

NOTE: Data submitters must coordinate with all of their partners such that trial information is submitted only once, by one of the above entities, to

View the Data Element Definitions to see details on the information that is entered via the PRS.

For U.S. submitters, additional guidance is provided by the U.S. Food and Drug Administration:

View the FDA Guidance Document for additional information.

View the Draft FDA Guidance Document covering the Best Pharmaceuticals for Children Act.

Preview the PRS mechanism for BPCA information.

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