Begin main content

Submit results to Clinicaltrials.gov

Information:

  • The Food and Drug Administration Amendments Act (FDAAA) is currently the prevailing policy related to results reporting in ClinicalTrials.gov.
  • FDAAA requires results reporting of Applicable Clinical Trials using approved products for any indication.
  • Investigators must report study results following FDA approval of drugs, biologics, or devices that have been approved for at least one indication by the FDA.
  • Generally, results must be reported within 12 months of the study’s primary completion date –which is defined as the date at which the last endpoint of the primary endpoint was collected.

Resources:

▪ Partners Human Research Affairs FDAAA Clinical Trials Registration and Reporting Policy
Partners Human Research Committee Clinical Trials Registration: A Resource For Partners Investigators
Partners QI Program ClinicalTrials.gov Support
Partners QI Program: Does Your Study Need Results Reporting?
Partners QI Program: Identifying an “Applicable Clinical Trial” under FDAAA

Courses:

ONLINE:
Clinical Trials.gov Overview of ClinicalTrials.gov
Clinical Trials.gov Results: Adverse Events Module
Clinical Trials.gov Results: Baseline Characteristics Module
Clinical Trials.gov Results: Outcome Measures and Statistical Analyses Module
Clinical Trials.gov Results: Participant Flow Module

LIVE TRAINING:
ClinicalTrials.gov: An Introduction to Results Reporting
ClinicalTrials.gov: Does Your Study Need Results Reporting?

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts.