ClinicalTrials.Gov (ct.gov) is a web-based resource that provides the public with access to both publicly and privately supported clinical study information. It is also a federally mandated database maintained by the National Library of Medicine (NLM) through the NIH that contains a database (or “registry”) of clinical trial studies involving human participants. Clinical Trial registration in ClinicalTrials.gov is a federal regulation under the United States Food and Drug Administration Modernization Act (FDAMA). FDAMA describes both the registration and update requirements as well as the criteria that must be met for study registration to be required.
The Rush Office of Research Affairs (ORA) offers several guidance documents and resources to aid study teams in determining whether registration is necessary and walking them through the registration process, updating requirements, and results posting.
Please self-register for the e-learning module “An Introduction to ClinicalTrials.Gov” in the Rush Learning Hub for an overview of the regulations and policies surrounding study registration, as well as helpful tips for maintaining compliance.