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“Who is responsible for registering a clinical trial in CTRI—principal investigator, sponsor, or institution—and what are the key steps in the registration process?”
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A responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility. The “Registrant” for a trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties. The primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration.