Data Safety Monitoring

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The NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.

Monitoring should be commensurate with risks -- The method and degree of monitoring needed is related to the degree of risk involved.  A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully.

Data Safety Monitoring Plans
A Data and Safety Monitoring Plan (DSMP) is just one of the mechanisms used to ensure the safety of study subjects as well as maintain data validity, integrity, and scientific merit. UCSF policy requires that all interventional studies involving more than minimal risk must include a DSMP. DSMPs depend upon many variables, such as the degree of risk, disease being studied, subject population, and number of sites where the research is being conducted. Complex DSMPs frequently include a Data Safety Monitoring Board (DSMB). The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC).

UCSF DSM Protocol Examples
Examples contributed by UCSF faculty provide language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more. 

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