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Investigators must report study results to ClinicalTrials.gov following Food and Drug Administration (FDA) approval of drugs, biologics or devices that have been approved for at least one indication by the FDA.
The Food and Drug Administration Amendments Act (FDAAA) is currently the prevailing policy related to results reporting in ClinicalTrials.gov.
The FDAAA requires results reporting of applicable clinical trials using approved products for any indication.
Investigators must report study results following Food and Drug Administration (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 by "the date at which the last endpoint of the primary endpoint was collected."
The Division of Clinical Research (DCR) at Massachusetts General Hospital offers biostatistical consultations that can be utilized when you are submitting results to Clinicaltrials.gov.
Investigators are encouraged to meet with a biostatistician before beginning a clinical trial to ensure that they are capturing all data needed for eventual results reporting.
To request a biostatistical consultation:
The DCR helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offering from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.
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