January 18, 2017
Mandatory Clinical Trials Registration and Results Reporting –
New Penalties for Non Compliance
GUMC Registration of Clinical Trials
Dear User (Principal Investigator):
New additional registration and results reporting requirements for clinical trials that meet the FDA and/or NIH criteria are listed below. Registration at https://register.clinicaltrials.gov is required NO LATER than 21 days after enrolling your first participant. Studies initiated prior to January 18, 2017, must still comply with existing registration and reporting requirements. Click HERE for more detailed instructions.
Below you will find the most frequently asked questions of ClinicalTrials.gov. Please read through the material. A reference guide for the PRS can be found at http://prsinfo.clinicaltrials.gov.
- History, Laws and Policies
- Media/Press Resources
- Why Should I Register and Submit Results?
- How to Apply for an Account
- Training Materials
- Support Materials
- FDAAA 801 Requirements
- NIH – Summary Table of HHS/NIH Initiatives to Enhance Availability of Clinical Trial Information
- Identifying an “Applicable Clinical Trial” under FDAAA
- Final Rule Webinar Series, Overview of ClincialTrials.gov, Submitting Results Data, Results Database
- “About the Results Database”
Related Journal Publications
- Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov - the final rule. N Engl J Med; 2016 Nov 17;375(20):1998-2004. [Full Text]
- Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med. 2016 Jan 19;13(1):e1001946. [Full Text]
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-60. [Full Text]
- Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]
- Zarin DA, Tse T. Moving towards transparency of clinical trials. Science. 2008;319(5868):1340-2. [Full Text (author manuscript)]
- Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007;297(19):2112-20.