COVID-19 (Novel Coronavirus): Please click here for FAQs: Impact of COVID-19 on Human Subjects Research

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).

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. Certain studies listed on ClinicalTrials.gov should have their Overall status changed from ‘Recruiting’ or ‘Enrolling by Invitation’ to ‘Suspended‘, within 30 days of the change. In addition, it is likely that anticipated dates such as the  Primary Completion Date and the Study Completion Date will have to be moved forward for paused studies. 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 7382) for additional information and/or assistance making any required edits. Once the research restrictions are lifted, the Overall Status will need to be edited to the category that best reflects study enrollment activity.

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

  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 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

Zarin DA, Fain KM, Dobbins HD, Tse T, Williams RJ. 10-year update on study results submitted to ClinicalTrials.govN Engl J Med. 2019 Nov 14; 381:1966-1974. [Full Text]

Tse T, Fain KM, Zarin DA. How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to considerBMJ. 2018;361:k1452. [Full Text]

Lynch HF, Largent EA, Zarin DA. Reaping the bounty of publicly available clinical trial consent formsIRB. 2017. Nov-Dec; 39(6). [Full Text (author manuscript)]

Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on trial registration 11 years after the ICMJE Policy was establishedN Engl J Med. 2017 Jan 26;376(4):383-391. [Full Text]

Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS)PLoS Med. 2016 Jan 19;13(1):e1001946. [Full Text]

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