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Trials Reviewed by a NIMH-Constituted DSMB.
DSMB Report Form for Moderate-High Risk Trials (unblinded) DSMB Report Form Template; If study team is blinded, contact IDS to provide randomization codes to DSMB statistician or administrator; Once your protocol materials have been reviewed by the TraCS DSMB, a review letter will be issued to you.
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Study teams developing materials for a study-constituted independent DSMB may benefit from reviewing the data report template and the protocol amendment memo. A conflict of interest exists when a DSMB member has a financial interest that could be affected by the study or a relationship with a study investigator. Data Safety Monitoring Board (DSMB) or medical monitor may be part of a DSMP, but it is not the entire DSMP.
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