Please see a new policy below on UK investigator-initiated clinical trials.
What: The Office of the Vice President for Research has implemented a policy regarding clinical trial registration and results dissemination in ClinicalTrials.gov.
Why: The University of Kentucky is committed to complying with regulations from the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and other federal entities.
Who: All UK Principal Investigators (PIs) conducting investigator-initiated clinical trials. The policy includes the responsibilities of the PI (responsible party), other individuals and departments; requirements and penalties; and enforcement actions.
The Bottom Line: Requirements and enforcement actions for ClinicalTrials.gov registration and results reporting vary among regulatory agencies, sponsors and journal editors. While some requirements overlap, there are important differences. The policy provides an overview of registration and results reporting requirements as well as potential penalties for noncompliance.
The university has an ethical obligation to ensure that ongoing clinical trials are accessible to the public and that data resulting from those trials contribute to generalizable knowledge and the advancement of public health. This commitment to transparency increases patient enrollment in clinical trials, enhances adherence to research protocols, mitigates information bias, reduces duplication of effort, and supports public access to and trust in the clinical trial process.
View the policy pdf: Registration, Dissemination and Results Reporting of Clinical Trial Data in ClinicalTrials.gov
