Guidance and Helpful Tips

Guidance and Helpful Tips

For assistance, including: registration of a clinical study to obtain the NCT identifier required by the IRB for all clinical trials, accessing/becoming a ClinicalTrials.gov user, resetting a forgotten password, reporting results for registered studies, posting required documents, and scheduling a training session for PIs and research team members, investigators at BMC and BU Medical Campus should contact the PRS Administrator (Karla Damus, damusk@bu.edu, 617 358 7382). There is also a monthly drop-in session for ClnicalTrials.gov every third Wednesday in Evans 739 between 2p and 4p.   For additional times/dates contact Karla Damus.


Helpful Tips for Registering, Updating and Reporting Results on ClinicalTrials.gov

FAQs- ClinicalTrials.gov provides a regularly updated, comprehensive list of frequently asked questions (FAQs) that provide the latest information about most topics and for additional questions, contact the PRS Administrator or email ClinicalTrials.gov at register@clinicaltrials.gov.

Please note: Posting results on CTgov [which is required for all Applicable Clinical Trials [ACTs] and for any clinical trial that receives NIH funding after Jan 17, 2017] is NOT considered to be prior publication.  http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (paragraph 3 in Section 1)

Harvard Catalyst Clinical Trials Registration & Results Reporting (CTR3) Resources

  • Registration Tip Sheet [PDF]
  • Results Reporting Data Elements Overview [PDF]
  • Outcome Measure Considerations [PDF]


Slide presentations from the CTSA

ClinicalTrials.gov Registration Guide 2018 (Detailed information on how to register a study on ClinicalTrials.gov)     https://catalyst.harvard.edu/pdf/regulatory/CTGOV_HOWTOREG.pdf

ClinicalTrials.gov Results Reporting from the Ground Up (Detailed information on how to post results on ClinicalTrials.gov and how to respond to comments from the CTgov PRS review) https://catalyst.harvard.edu/pdf/regulatory/CTSA%20Results%20Presentation.pdf


Articles

Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov – the final ruleN Engl J Med. 2016 Nov 17;375(20):1998-2004. [Full Text]

Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issuesN Engl J Med. 2011;364(9):852-60. [Full Text]

Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issuesN Engl J Med. 2011;364(9):852-60. [Full Text]


Related Websites

ClinicalTrials.gov

Register.clinicaltrials.gov

FDAA TrialsTracker

BMJ Unreported Clinical Trial of the Week

Alltrials.net