D10 - Clinical Trials in SBER

NIH has implemented policies designed to improve stewardship, accountability, and transparency of clinical trials, including some research characterized as basic science. SBER IRBs (and their research communities) need to understand the special NIH requirements for clinical trials. The revised Common Rule also imposes additional requirements for projects identified as clinical trials. Before attending this session, attendees should have a basic knowledge of NIH clinical trial policies and 45 CFR 46. NIH-funded research projects meeting the NIH definition of clinical trials must be registered and results reported on ClinicalTrials.gov. For investigators and institutions that do not typically work with clinical trials, meeting these requirements can be challenging. This session is designed to provide an overview and tips for assisting SBE researchers and institutions with ClinicalTrials.gov responsibilities. Before attending this session, attendees should have basic knowledge of ClinicalTrials.gov.