Frequently Asked Questions

• Yes, Section 801 of FDAAA amended the FD&C Act authorizes civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements.
• In relation to federally funded studies, section 402(j)(5)(A) of the PHS Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information.
• ICMJE policy requires, and recommends that all medical journal editors require, registration of clinical trials prior to the start of enrollment as a condition of consideration for publication. Additionally, ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding posting of results to ClinicalTrials.gov.

• No, posting of tabular results data to ClinicalTrials.gov is not considered prior publication. Here’s the ICMJE policy.

• If required, results must be posted within 12 months of the Primary Completion Date, that is, within 12 months of the last study visit where you collected data for your primary outcome measure.
• This 12 month deadline has nothing to do with IRB closure, publication, data analysis, etc. so be prepared to your data within 12 months of your last study visit.

• Briefly, before enrollment begins. Applicable Clinical Trials and NIH-funded clinical trials are required to register within 21 days of enrolling the first subject. However, ICMJE policy requires registration prior to the start of enrollment.

• The P.I. (the record owner) is responsible for:
  • Registering the study on ClinicalTrials.gov
  • Maintaining and updating the record (see our Required Record Updates sheet)
  • Reporting basic results data to ClinicalTrials.gov, if required
  • Responding to comments and addressing QA issues with the record identified by the ClinicalTrials.gov Protocol Registration and Results System (PRS) staff and UCD AMC ClinicalTrials.gov administrators
• Incoming or departing faculty must transfer their ClinicalTrials.gov records with them. Contact clinicalresearchsupportcenter@ucdenver.edu and we’ll help you transfer your records. (Once Research Transfer resources are ready, lets link to that page)

• Yes, if your study is an Applicable Clinical Trial (ACT), or probable ACT.
• Yes if NIH funded and subject to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. Briefly, if initiated on or after 1/18/2017 and is a clinical trial, including a behavioral or phase 1 clinical trial.
• Yes, if otherwise required by a funder or policy (e.g. PCORI, NCI)

• The regulations governing posting require that Applicable Clinical Trials be registered, and have basic results reported to ClinicalTrials.gov. See Which Trials Must be Registered.
• In addition, some funding agencies, NIH, Bill and Melinda Gates, also require posting as do many journals.
• For investigator initiated studies conducted by UCD AMC faculty, the faculty P.I. is responsible for registering the study and maintaining the posting.
• For industry-sponsored trials, the sponsor will register and maintain the record.