Research Roundtable: ClinicalTrials.gov FAQ — Study Registration (Part 2)

ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and internationally. It has an extensive FAQ section ranging from general to investigation-specific. Many of these questions frequently arise at the University at Buffalo, primarily regarding either study registration or results posting. This edition of “Research Roundtable” highlights a selected FAQ, “Study Registration.” (This is part two of a two-part series focused on “Study Registration.” See part one here.)

The Responsible Party is responsible for registering the trial on ClinicalTrials.gov Protocol Registration and Results System (PRS), ensuring accuracy, and making sure the content is up to date. 

In the PRS, the Responsible Party field defaults to “Sponsor.” The University at Buffalo usually will require the following:

• If the study is under an IND or IDE, choose "Sponsor-Investigator" from the drop-down menu and choose the IND/IDE holder as the Sponsor-Investigator.
• If your study is not under an IND or IDE, choose "Principal Investigator" from the drop-down menu.
• If you are a student, resident, or fellow: Your Faculty Supervisor should be listed as the Overall Study Official in the Contacts section and should be added and should be given editing rights by adding them to the “Access List” on the Record Summary page.

Anyone listed as study key personnel may enter the registration information into ClinicalTrials.gov. You must have a ClinicalTrials.gov account to register a study. The person who creates the registration is designated as the Record Owner, or the main contact for the record.  

To prevent theft of intellectual property, it is advisable that the study registration include basic information written for a non-scientific reader (eighth grade level). Primary and secondary objectives should be put in the Brief Summary; the Detailed Description is optional and can be left blank. It is recommended that eligibility criteria is a limited list (as in the ClinicalTrials.gov Protocol Data Element Definitions). 

Document upload is not required at registration in the Protocol Section.

The Primary Completion Date is defined as “the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated.” The Study Completion Date is the “date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events.”

Certain data elements need to be updated within 30 days of a change (e.g. Overall Study Status, Completion Dates, Study Start Date, Individual Site Status). Review and update your record at least annually until all required registration and results information has been submitted. 

Your National Clinical Trial (NCT) number will be assigned once your study has been reviewed by the ClinicalTrials.gov PRS team. PRS Staff review the study record for apparent errors, deficiencies, and/or inconsistencies. If PRS Staff find any potential issues with the record, they will add comments to the record and send an email notification. You must log in to PRS to view and address the comments and to resubmit the record for PRS Review. Click on the Red Flag Icon to see the PRS comments. Your study is not registered or made public until the study has an NCT number.

For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team (UBClinicalTrialsgov@buffalo.edu) or ClinicalTrials.gov Protocol Registration and Results System Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.

Watch for “ClinicalTrials.gov FAQ — Study Results Entry” in an upcoming edition of “Research Roundtable.”

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter. Add your email to the newsletter mailing list here.