Submit results to Clinicaltrials.gov
- 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.
▪ 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
▪ 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