When to report results on ClinicalTrials.gov?

ClinicalTrials.gov Reporting Assistance

Bernie LaSalle, Operations Director,

CCTS Biomedical Research Informatics Service Core*

bernie.lasalle@hsc.utah.edu

801-213-4093

 *Costs vary depending on the type of support required and the availability of data for the report summary tables.  Please contact Bernie LaSalle to discuss your support request.

FDAAA requires reporting of study results for Applicable Clinical Trials no later than 12 months after the date of final data collection for the primary outcome measure, referred to as the “Primary Completion Date.” 

Delayed Submission of Results

A Responsible Party may delay submission of results, until the deadline described below, by submitting a certification (see note) that an Applicable Clinical Trial meets either of the following conditions:

  • The trial reached its completion date before the drug, biologic, or device is initially approved, licensed, or cleared by FDA for any use (referred to on ClinicalTrials.gov as "certify initial approval")
    • results deadline: no later than 30 days after the drug or device is approved, licensed or cleared by the FDA

 

  • The trial studies a new use of an FDA-approved drug, biologic, or device (that is, a use not included in the labeling) for which the manufacturer of a drug, biologic, or device is the sponsor of the trial and has filed or will file within 1 year an application to FDA for approval or clearance of that use (referred to on ClinicalTrials.gov as "certify new use")
    • results deadline: (1) the earlier of the date that is 30 days after the date:
      • new use of the drug or device is approved, licensed, or cleared by FDA
      • FDA issues a letter for the new use of the drug or device, such as a complete response letter
      • the application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days;
  • or (2) two years after the date a certification is submitted, if none of the events listed above have occurred.

 

Note: If a Responsible Party, who is both the sponsor and manufacturer, submits a new use certification this certification must be made with respect to each Applicable Clinical Trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.

Per FDAAA, sponsors must also include study results in the registry. The results submissions should include lay language summaries of subject demographics and characteristics, primary and secondary outcomes, and disclosures of any privacy agreements. Timelines for this information are set forth (see related links below). University of Utah recommends that the Responsible Party stay informed about these requirements, as they evolve.

 

Further Information:

Completion Date

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=83

 

Delayed Submission of Results

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=91

 

FDAAA 801 Requirements (ClinicalTrials.gov Website)

http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering

 

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