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Bookmark or Share- Data and Safety Monitoring Board (DSMB) GuidelinesThe Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises NIDCR. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations.
- Guidelines for Establishing and Operating a Data and Safety Monitoring ...This document has been created to assist grantees in establishing and operating a Data and Safety Monitoring Board (DSMB) for clinical trials sponsored by the National Institute on Drug Abuse (NIDA). Monitoring by a DSMB is required by NIH for some trials or may be implemented by a grantee whenever he/she feels it is appropriate.
- Establishment and Operation of Clinical Trial Data Monitoring ...This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety...
- Guidelines for Establishing and Operating a Data and Safety Monitoring ...Guidelines for Establishing and Operating a Data and Safety Monitoring Board. Guidance for assisting grantees conducting or planning to conduct clinical trials, has developed these guidelines for data and safety monitoring (DSM) plans, in accordance with NIH requirements. The purpose of the DSM plan is to ensure the safety of parties.
- Data and Safety Monitoring Plans and BoardsA DSMB or DMC is a formal committee — independent of the trial organizers and investigator(s) — that is specifically established to conduct interim monitoring, oversight and analysis of study information and data to assure the continuing safety of research participants, efficacy of the study intervention, appropriateness of the study ...
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