ClinicalTrials.gov provides current information about clinical research in human volunteers. The Protocol Registration System (PRS) is a Web-based tool developed for submitting information to ClinicalTrials.gov.
A PRS account is required for submitting study information to ClinicalTrials.gov. Trial data may be submitted by the following entities:
All studies submitted to ClinicalTrials.gov 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 ClinicalTrials.gov.
View the ClinicalTrials.gov 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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