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Submit results to


  • The Food and Drug Administration Amendments Act (FDAAA) is currently the prevailing policy related to results reporting in
  • 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.


▪ 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 Support
Partners QI Program: Does Your Study Need Results Reporting?
Partners QI Program: Identifying an “Applicable Clinical Trial” under FDAAA


Clinical Overview of
Clinical Results: Adverse Events Module
Clinical Results: Baseline Characteristics Module
Clinical Results: Outcome Measures and Statistical Analyses Module
Clinical Results: Participant Flow Module

LIVE TRAINING: An Introduction to Results Reporting 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.