Data & Safety Monitoring
UTHealth policy requires that researchers conducting clinical investigations with human subjects submit a description of their Data and Safety Monitoring Plan (DSMP) as part of the iRIS application.
DSMPs* are just one of the mechanisms used to ensure the safety of study subjects as well as maintain data validity, integrity, and scientific merit.
We can help you with your DSM plan, which can range from being simple and just having an appointed safety officer, to more complex. Complex DSMPs frequently include a Data Safety Monitoring Board (DSMB). DSM plans 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.
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:
• more than minimal risk
• multi-site studies
• involve a vulnerable population (pediatric, geriatric)
• blinded studies
• new therapies or science
We also provide guidance for assembling your DSMB, in addition to help with writing charters and reports. Please contact us for templates and suggestions for best practices for manifesting your DSMP.
- Primary and secondary outcome measures
- Inclusion/exclusion criteria
- Sample size
- List of participating enrolling clinics or data collection centers
- Projected timetable
- 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)
For further information, please visit these sites:
Guidance for Clinical Trial Sponsors
NDDK: Generic DSMP for studies requiring a DSMB
Generic DSMP for studies not requiring a DSMB
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