Beginning December 18, all new nPBA applications and all existing PBA applications will show new questions about registering studies with ClinicalTrials.gov. Historically, these questions have simply asked the PI to determine whether their study meets one or more of the registration criteria set out by a federal entity (FDA, NIH) or working group (ICMJE); these new questions attempt to break down these criteria into easier to understand pieces that will guide the PI through the determination process.

Don’t forget UW-Madison HRPP offers comprehensive support for ClinicalTrials.gov records as a free service to all study teams via the ClinicalTrials.gov Service Line.

To submit feedback on these new questions or for general ClinicalTrials.gov information, please email ClinicalTrials.gov_Support@research.wisc.edu.