Guidance and Helpful Tips
During the current government shutdown, information on the ClinicalTrials.gov website may not be up to date, and new submissions or updates may experience delays in processing. Additionally, responses to inquiries from the agency may be temporarily delayed until normal operations resume. For updates on the federal government’s operating status, please visit opm.gov.
Specific impacts to study registrations, updates and submitting results include:
New Study Registration and Updates to Registered Studies Although the Responsible Party/RP can still create a new registration record and make updates/edits to existing records in the PRS databases, only NIH-funded or Applicable Clinical Trial/ACT (an interventional study involving an FDA-regulated drug, biologic, or device that is not a Phase I drug study or a small device feasibility study) studies can be released for NLM review. All other studies will not be released until the shutdown ends.
Submitting Results The RP can still enter results into any record, only NIH-funded or ACT studies will be released for NLM review. All other studies will not be released until the shutdown ends.
If you have any questions or need assistance, contact the CTgov Administrator.
Guidance and Helpful Tips for Registering, Updating and Reporting Results on ClinicalTrials.gov
| For CTgov assistance, such as: accessing/becoming a ClinicalTrials.gov user, registration of a clinical study to obtain the NCT identifier, resetting a forgotten password, posting results for registered studies, posting required documents, and scheduling an individual or group CTgov zoom training session/s for PIs/researchers and research team members at the BU Medical Campus and BMC, contact the BMC/BUMC PRS Administrator (Karla Damus, damusk@bu.edu, 617 358 5337).
For CTgov assistance at the BU Charles River Campus contact the IRB Director and Clinical Trials Registration (LaNeia Thomas, laneia@bu.edu, 617 358 6346). |
Classic ClinicalTrials.gov website was retired on June 25, 2024- The ClinicalTrials.gov Modernization Initiative (2019-2025) is near completion and on June 25, 2024, the NLM’s modernized ClinicalTrials.gov website became the singular public website experience for all users. On August 28, 2024 the Modernized beta PRS ClinicalTrials.gov website became the primary website for the institutional/sponsor specific PRS. However, some PRS features can still only be done on the classic PRS so currently both the classic and the modernized PRS sites are available. For any questions or challenges navigating the modernized sites, contact the CTgov Admnistrator, damusk@bu.edu.
BUMC/BMC HRPP policies related to clnicaltrials.gov [Section 6.6.9 Registering, Updating, and Posting Requirements for Clinical Trials]
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 [damusk@vu.edu] or email ClinicalTrials.gov at register@clinicaltrials.gov
CTgov updates to access the latest updates anews about clinicaltrials.gov go to this site
‘Getting to Know ClinicalTrials.gov’ section in the Clinical Research Times This section has articles with tips and information about ClinicalTrials.gov 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 ClinicalTrials.gov’. 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. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (paragraph 3 in Section 1)
Data sharing required by ICMJE
- As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement.
- 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 – http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf
CTgov Related Articles Links to scholarly publications about ClinicalTrials.gov and clinical research, written by ClinicalTrials.gov 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 ClinicalTrials.gov‘
FDA ClinicalTrials.gov webinars In a three-part on demand webinar series, the FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements.
Related Websites