University of Pittsburgh Office for ClinicalTrials.gov
ClinicalTrials.gov is a Web-based resource that provides the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
NIH Funded Clinical Trials
Effective January 18, 2017, the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information establishes the expectation that all NIH-funded awardees and investigators conducting a clinical trial For the purpose of the NIH policy, means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. This definition includes phase 1 trials of FDA regulated drug and biological products, small feasibility studies of FDA-regulated device products, and studies of any intervention not regulated by the FDA, e.g. behavioral interventions. This definition of “clinical trial is broader than the term “applicable clinical trial” as defined by FDAAA. , funded in whole or in part by the NIH will ensure that their NIH funded clinical trial is registered at and summary results information is submitted to ClinicalTrials.gov. These requirements will be included in the terms and conditions of the award. Failure to comply with these requirements may lead to enforcement actions. Although the policy does not apply to NIH funded clinical trials initiated before the effective date, the NIH encourages all ongoing NIH funded clinical trials to follow it.
ClinicalTrials.gov is offering a series of three live webinars to provide responsible parties with information about the final rule for Clinical Trials Registration and Results Information Submission (42 CFR part 11).
Each webinar will cover a different aspect of the final rule, including an overview of which applicable clinical trials are covered, what clinical trial registration and results information is required under the "expanded" requirements, and when the requirements take effect. Each webinar will be archived and publicly available for online viewing after the event. There is no cost to participate in the webinarsLink to Training Materials and Webinars
Please contact CTgov@pitt.edu if you have questions or need to establish an account.