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Who Is Responsible for Registering Trials on ClinicalTrials.gov?

The entity responsible for registering is the "responsible party." The statute defines the responsible party as:

(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information. See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)). Elaborations of these definitions can be found here.

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