The investigator’s commitment to the sponsor (in the standard clinical research/regulatory sense) is to comply with the signed “Statement of Investigator” obligations , which include things like conducting the study according to the protocol, personally supervising it, reporting adverse events, and maintaining accurate records.

Core commitment in simple terms

An investigator formally commits to the sponsor (for example, via FDA Form 1572 in drug trials) to:

  • Conduct the investigation according to the approved protocol and only make changes after notifying the sponsor, except when needed to protect subjects’ safety.
  • Personally conduct or adequately supervise the investigation and ensure staff are properly informed of their duties.
  • Inform subjects that the test product is investigational and ensure proper informed consent and ethics (IRB) review.
  • Report adverse experiences to the sponsor and maintain adequate, accurate study records for the required retention period.

If your original question was multiple-choice (“Which of the following is an investigator’s commitment to the sponsor?”), the correct option is typically the one that says something like:

“Conduct the study according to the protocol and applicable regulations, personally supervise it, report adverse events, and maintain adequate and accurate records.”

All of those are classic elements of an investigator’s regulatory commitment to the sponsor.

Information gathered from public forums or data available on the internet and portrayed here.