Who is responsible for clinical trial registration on ClinicalTrials.gov?

The sponsor is the entity that is responsible for registering clinical trials on ClinicalTrials.gov. This responsibility typically falls on the organization or individual who initiates, manages, and is accountable for the clinical trial. The sponsor must ensure that the trial is registered in compliance with regulations set forth by the Food and Drug Administration (FDA) and to maintain transparency in the clinical research process.

Registration on ClinicalTrials.gov is crucial as it provides essential information to the public, including the study's purpose, who may participate, locations, and contact information. By registering trials, sponsors contribute to the prevention of duplicative research, facilitate participant recruitment, and uphold ethical standards within the research community.

In contrast, while institutions, Sponsored Research Offices, and Institutional Review Boards (IRBs) play significant roles in the oversight and management of clinical trials, they are not the primary entities responsible for the registration itself. The institution may support the sponsor, the Sponsored Research Office may assist with compliance and administrative functions, and the IRB focuses on the ethical treatment of participants and protocol review, but the ultimate responsibility for registration lies with the sponsor.