Who is responsible for registering the trial?
The sponsor of the clinical trial; – OR – The principal investigator (PI) of such clinical trial if so designated by a sponsor, contractor, grantee, or awardee, so long as the PI is responsible for conducting the trial and has sufficient data rights. For NIH-funded clinical trials where there is an IND holder, consistent with FDA regulations, the IND holder is the sponsor, and will be considered the responsible party unless this obligation is delegated to the principal investigator. For NIH-funded clinical trials where there is no IND holder, the funding recipient will be considered the responsible party.
