Certified Research Administrator Practice Exam

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

1. Sponsor

2. Institution

3. Sponsored Research Office

4. IRB

The correct answer is: Sponsor

The responsibility for clinical trial registration on ClinicalTrials.gov primarily lies with the sponsor of the trial. Sponsors are typically the organizations or entities that initiate, manage, and finance a clinical trial. This can include pharmaceutical companies, academic institutions, or other research organizations that design the trial and thus have a vested interest in ensuring that it is properly registered. Registering a trial is crucial for a number of reasons, including promoting transparency in the research process, ensuring that potential trial participants are informed about available studies, and allowing stakeholders to access data on ongoing and completed trials. Sponsors are expected to provide accurate details about the trial, such as its purpose, methodology, and eligibility criteria. While other entities, like institutions, the Sponsored Research Office, and Institutional Review Boards (IRBs) are involved in various oversight and administrative functions surrounding clinical trials, they do not have the primary responsibility for registration on ClinicalTrials.gov. The institution typically supports the sponsor but does not take on the formal obligation for registration. The Sponsored Research Office may assist with administrative tasks, while IRBs focus on protecting the rights of participants and ensuring ethical conduct in research.