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 PlansA 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).
NIH Data Safety Monitoring Plan Information and TemplatesTo assist investigators in complying with the NIH data safety monitoring policy, please visit guidance and sample DSMP templates on the NIH website.CTSI Data Safety Monitoring Protocol Library The CTSI Data Safety Monitoring Protocol Library provides language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more. Access is limited to UCSF researchers.
Need assistance or have clinical study management questions?Please contact CTSI Design Services
Last updated 7 Aug 2014
DSMBs are made up of multidisciplinary members who are knowledgeable in the conduct of research, and should include those with backgrounds in biostatistics, experimental design, bioethics, and experts in the medical field of concern.
DSMBs are responsible for reviewing data and endpoints on a timeline set forth by the DSMP in the protocol, and are typically required for the following types of studies:
DSMB Collaboration with the IRBNCI guidelines are widely considered to be the most comprehensive and set forth requirements for DSMB composition and function; note that it is required that a majority of the members be drawn from outside the institution (or institute) conducting the study. DSMB membership is usually comprised of:
The DSMB is not specifically required to communicate with the IRB, but the intent is clear that the important information get to the IRB: "The study leadership will provide information on cumulative toxicities and relevant recommendations to the local principal investigators, to be shared with their IRBs."
Primary and secondary outcome measures
List of participating enrolling clinics or data collection centers
Target population distribution (e.g., women, minorities, etc.)Data acquisition and transmission
Data entry methods
Data analysis plan
Quality assurance plan
Reporting mechanisms of AEs/SAEs to the IRB, FDA, and NIDA.
Reporting mechanisms of IRB actions to NIDA
Report of changes or amendments to the protocol
Trial stopping rules
Conflict of interest
Potential risks and benefits for participants
Collection and reporting of AEs and SAEs
Management of SAEs or other study risks
Plans for Interim Analysis of efficacy data
Responsibility for data and safety monitoring
Frequency of DSM reviews
Content of DSM report
DSM Board Plan (if applicable
Need assistance or have clinical study management questions?Please contact CTSI Design Services.
National Institute of Diabetes and Digestive and Kidney Diseases (NDDK):
DSMP Guidelines from Various NIH Institutes:
National Cancer Institute
The HUB is a collaborative effort of the Office of Research, the Office of Ethics and Compliance and the Clinical & Translational Science Institute (CTSI).
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