Trial Registration and Results Reporting on ClinicalTrials.gov

Registration, updating records, and results reporting of clinical trials has two main purposes:  to inform potential subjects, and to increase the likelihood that negative results of trials will be publically available, thereby promoting transparency and scientific integrity. The U.S. Government site for registering clinical trials is ClinicalTrials.gov.  A study is issued a CT.gov NCT number when it is registered. A trial should only be registered and listed once. For investigator-initiated clinical trials, the Principal Investigator is considered the Responsible Party, and is the one who has to complete the registration.  For multi-center clinical trials, someone other than the local PI usually fulfills this responsibility. The Responsible Party who initially registered the clinical trial is also the one who must maintain the information about the trial, including updating recruitment information at least every 12 months and reporting final results if required.

To find out whether the rules and policies apply to your research click here.

Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov in NEJM (Nov. 2016)

For more information about the registration process, see the ClinicalTrials.gov website.

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, and updating or reporting results for registered studies, investigators at BMC and BU Medical Campus should contact Karla Damus, PhD, MSPH, MN, RN (damusk@bu.edu, 617 358 7382). There is also a monthly drop-in session for ClnicalTrials.gov every third Wednesday in Evans 739 between 2 and 4p.   For additional times/dates contact Karla Damus.