Guidance and Helpful Tips
Guidance and Helpful Tips
| For CTgov 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 an individual or group CTgov training session/s for PIs and research team members, investigators at BMC and BU Medical Campus, contact the PRS Administrator (Karla Damus, damusk@bu.edu, 617 358 5337). |
PLEASE NOTE: COVID-19 Impact on Overall Status, Anticipated Dates, and Brief Titles
Due to the COVID-19 pandemic, policies have been implemented impacting many clinical studies involving human subjects. Information about these policies and FAQs are posted on the IRB website. Also any clinical studies/trials that are on COVID-19 should include COVID-19 in their brief title to facilitate identification of COVID-19 research when a search of ClinicalTrials.gov is done. Please contact the BUMC/BMC CTgov PRS Administrator, Karla Damus (damusk@bu.edu, 617 358 5337) for additional information and/or assistance making any required edits.
Click here for Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) by ClinicalTrials.gov
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)
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 resources
http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf
http://www.icmje.org/news-and-editorials/proposed-disclosure-form-editorial.pdf
http://www.icmje.org/news-and-editorials/proposed-disclosure-form.pdf
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
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.
Related Websites
BMJ Unreported Clinical Trial of the Week