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Guidance and Helpful Tips

Guidance and Helpful Tips for Registering, Updating and Reporting Results on

For CTgov assistance, including: accessing/becoming a user, registration of a clinical study to obtain the NCT identifier required by the IRB for all clinical trials, resetting a forgotten password, reporting results for registered studies, posting required documents, and scheduling an individual or group CTgov training session/s for PIs/researchers and research team members at BMC and BU Medical Campus, contact the BMC/BUMC PRS Administrator (Karla Damus,, 617 358 5337).

Classic website will be retired on June 25, 2024- The Modernization Initiative (2019-2024) is near completion and on June 25, 2024, the NLM’s modernized website will become the singular website experience for all users. For any questions or challenges navigating the modernized site, contact the CTgov Admnistrator,

BUMC/BMC HRPP policies related to [Section 6.6.9 Registering, Updating, and Posting Requirements for Clinical Trials]

FAQs- 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 at

CTgov updates to access the latest updates anews about go to this site 

‘Getting to Know’ section in the Clinical Research Times This section has articles with tips and information about related to federal regulations, BMC/BUMC HRPP policies, record registration, outcome measures, posting results, the modernization initiative and much more. To review the articles go to CR Times and select ‘Archives’ in the banner. Then scroll down to: ‘To list articles sorted by date, select a category and click submit‘ and from the drop down menu select  ‘Getting to Know’. All the articles will be listed.

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. (paragraph 3 in Section 1)

Data sharing required by ICMJE

  1. As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement.
  2. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

Data sharing statements must indicate the following: whether individual de-identified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).

Data sharing plan examples –


CTgov Related Articles  Links to scholarly publications about and clinical research, written by staff and others by year of the publications can be accessed through this link. Titles of journal articles link to the PubMed® abstract for the publication, when available. Links to full-text versions of articles that are available for free are also provided.

CTgov informational podcast  presented by Anna M. Fine, PharmD, MS, Acting Director CTgov on 6/15/2023 about ‘What Researchers and Recipients Should Know about

FDA webinars  In a three-part on demand webinar series, the FDA provides a general overview of and relevant definitions, laws, and regulations for complying with registration and results information submission requirements.

Related Websites

FDAAA TrialsTracker