What if there is no sponsor to the clinical trial, who has to register?
If the PI is conducting an investigator initiated clinical study, then the PI will be the party responsible for registering the trial. For NIH studies, e.g. R01 grant awards, PIs should verify the responsible party status via written communication with NIH. Clinical trials conducted via cooperative group agreements, contracts, or Institutes or Centers may provide for registration through a central mechanism. Because of the short timeline for implementation of the law always verify who is responsible with the granting agency. In the future executed grants and contracts will identify the responsible party.
Related Questions
- The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?
- How do I register my ownership of shares on the CHESS Subregister? What is a CHESS Sponsor?
- What if there is no sponsor to the clinical trial, who has to register?
