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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 United States Food and Drug Administration (FDA) requires that clinical investigators submit a final report for an investigational new drug (IND) or investigational device exemption (IDE) upon closure of a clinical research project.
The final report for an IND is included in the annual report for the project.
At minimum, this report should include:
The Division of Clinical Research (DCR) at Massachusetts General Hospital 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 offerings 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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