Who bears responsibility for submitting the regulatory applications required before starting a trial?

• A. Sponsors.
• B. Investigators.
• C. IRB/IEC.
• D. Regulatory authorities.

Answer: (A)

The sponsor bears responsibility for submitting regulatory applications to obtain permission to start the trial. In practice, the sponsor compiles and submits the necessary documentation to the regulatory authorities — such as the protocol, investigator brochure, safety information, and other required reports — and coordinates with sites to ensure that all approvals are in place before any participant is enrolled. This centralized regulatory submission responsibility ensures that the trial meets legal and safety requirements across relevant jurisdictions.

The investigators at each site play a crucial role too, mainly by ensuring local conduct in line with the protocol and obtaining ethics committee or IRB approval for their site. However, ethical approval does not substitute for the regulatory authority approvals, and the submission to regulators typically sits with the sponsor (or sponsor–investigator in some arrangements). Regulatory authorities grant permission to initiate, while IRBs/IECs review the ethical aspects at each site.