Category Archive: Child of Clinicaltrials.gov

Program Highlights


Program highlights: 2.5 FTEs of dedicated staffing Nidhi Atri, M.D. Prince Nuamah, M.D. Anthony Keyes, MBA, PMP Statistical expertise Provided by the BEAD Core http://jhcchr.org/bead First 1-hour covered by the program Most concerns can be handled in the 1-hour consultation Additional time needed and costs can be discussed Study team assistance Registration Account creation and maintenance Initial registration -Required for Applicable Clinical Trials -NEW: required for any clinical trial receiving full or partial NIH funding PRS reviewer comments (now time-limited to 15 calendar days) Update reminders (required every 12 months regardless of changes) Results reporting Changes to PI/Study team (including when … Continue reading

Timeline


  Year Entity Event 1997 Congress 1st U.S. law to require trial registration (FDAMA) 2000 NIH Releases ClinicalTrials.gov website 2005 ICMJE Requires registration before enrollment 2006 WHO All clinical trials should be registered 2007 CMS PI must enroll qualifying clinical trials in ClinicalTrials.gov 2007 Congress Expanded registration, submission of results and adverse events, civil penalties (FDAAA) 2008 NIH Releases results database 2015 CMS Mandatory Reporting of Clinical Trial Number on Claims