What are the NIH Requirements for ClinicalTrials.gov Registration Information in Applications and Progress Reports?
On September 27, 2007 Congress enacted U.S. Public Law 110-85 (also known as H.R. 3580, or Food and Drug Administration Amendments Act of 2007). This act mandates the expansion of ClinicalTrials.gov, expands the required submission elements and establishes penalties for not listing a trial. Investigators and sponsors must ensure that applicable drug, biologic and device trials are registered within 21 days of enrollment of the first subject and preferable before first subject enrollment. The legislation also requires applications or progress reports for any clinical trials required to be registered which are funded in whole or in part by a grant from any agency of the Department of Health and Human Services to contain specific information certification registration in ClinicalTrials.gov. How do the FDA registration requirements affect NIH funded studies? Competing renewal applications that include studies that are required to be registered must include as part of the Human Subjects Sec
Related Questions
- The policy states that NIH applications, proposals or progress reports must include the PMCID for any references. What is that and how do I find this?
- With the advent of electronic submission of applications to NIH, where can I get information on pre-submission requirements such as registration?
- What are the NIH Requirements for ClinicalTrials.gov Registration Information in Applications and Progress Reports?
