Creating a Program to Support Registering and Reporting Clinical Trials at Johns Hopkins University.

Problem: The Food and Drug Administration Amendments Act of 2007 (FDAAA) and the National Institutes of Health (NIH) require that many clinical trials register and report results on ClinicalTrials.gov. Noncompliance with these policies denies research participants and scientists access to potentially relevant findings and could lead to monetary penalties or loss of funding.

Addressing the quality of submissions to ClinicalTrials.gov for registration and results posting: The use of a checklist.

Background: US Federal regulations since the late 1990s have required registration of some clinical trials and submission of results for some of these trials on a public registry, ClinicalTrials.gov. The quality of the submissions made to ClinicalTrials.

Time From Submission of Johns Hopkins University Trial Results to Posting on ClinicalTrials.gov.

This study evaluates the time between submission of trial results to the National Institutes of Health and public posting of the results.