Yes. The sponsor of the clinical trial, whether an individual or entity, is the responsible party, unless the principal investigator has been designated the responsible party in accordance with 42 CFR 11.4(c)(2). The principal investigator may be designated by a sponsor, 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 the regulation for submitting and updating of clinical trial information. If the principal investigator does not meet the specified conditions for serving as the responsible party, the sponsor cannot designate the principal investigator as the responsible party, and the sponsor must remain the responsible party.
The format for designation of the principal investigator as the responsible party by the sponsor is specified in ClinicalTrials.gov by having the principal investigator submit clinical trial information via the sponsor’s Protocol Registration and Results System (PRS) organizational account (the sponsor must provide an account for the principal investigator within the sponsor’s PRS organizational account). The acknowledgement is reflected by having the principal investigator list their name as the responsible party and indicate that they were designated as the responsible party by the sponsor.
If and when a designated principal investigator no longer meets or is no longer able to meet all of the requirements of a responsible party, 42 CFR 11.4(c)(3) outlines the mechanisms by which, if the withdrawal of such designation occurs, the sponsor would become the responsible party. This might occur if, for example, a principal investigator dies, retires, changes jobs, or turns control of the clinical trial data over to the sponsor.
