Clinical Trial - Risk Assessment and Data Safety Monitoring Plan
A Data and Safety Monitoring Plan (DSMP) is required for all research, regardless of the risk level. Investigators must have adequate plans in place to protect human subjects throughout data collection and analysis. Investigators should maintain a data safety monitoring plan and update policies throughout the research.
Clinical Trials conducted at MIT are required to comply with this policy and have adequate data safety monitoring plan in place throughout the trial. The Principal Investigator is responsible for ensuring that an appropriate DSMP is in place at the time of initial COUHES approval and ensuring to implement the plan throughout the study.
Investigators should check with their Program Officer or funding agency for specific requirements regarding the funding center’s policy and guidance. Visit the NIH Data Safety page for more information.
Overview
Investigators must include a DSMP with the initial COUHES submission for a clinical trial. The DSMP should be commensurate with the risks, size, complexity, type of participant population and type of study. The DSMP must include:
- Explanation of the primary and secondary outcome measures.
- Explanation of the process to monitor study progress and participant safety.
- Identify the investigator(s) responsible for monitoring the study, frequency of DSMP reviews, and contact of DSMP reports.
- Management and reporting mechanisms of adverse events, unanticipated problems, or other study risks to the IRB and other entities engaged in the study.
- Plans for withdrawing participants from study interventions.
- Stopping rules (if applicable)
- Data Safety Monitoring Board Plan (if applicable)
The Comprehensive Review Application: Comprehensive Review includes all the necessary information to allow COUHES to make an informed decision during the review process and to confirm the appropriate safety measures are in place.
The Principal Investigator is responsible for ensuring the study is in compliance with the policies set forth in the DSMP and to revisit the policy periodically. DSMP should change intermittently as the study progresses and potential risks to participants are identified.
During initial and continuing review of research, COUHES considers factors such as the risk, size, and complexity of the research to determine if the DSMP is adequate. Examples of factors that increase risk and complexity include large study population; multiple study sites; procedures moderate or significant risk; vulnerable population; and investigational devices. The requirements outlined below represent the minimum amount necessary to assure participant safety. COUHES may require more frequent and/or additional monitoring. Standard reporting to COUHES of unanticipated problems involving risks to participants or others and adverse events is required regardless of the level of monitoring.
In rare cases, COUHES may require an independent advisory body, known as a Data Safety Monitoring Board (DSMB), oversee the research. The DSMB provides recommendations regarding study modification, suspension, or termination. DSMB is recommended for large, blinded studies involved multiple sites.
Monitoring Requirements
Low to Moderate Intensity Monitoring is required for research involving less than significantly greater than minimal risk.
Research with Low to Moderate Intensity Monitoring are required to comply with the following:
- Continuous monitoring by the PI or assigned monitor with prompt reporting of adverse events and unanticipated problems.
- Appropriate protections are in place to adequately identify adverse events promptly.
- Regular meetings with the research teams to discuss protocol issues, review adverse events, and address concerns relating to the risk to participants.
- If applicable, stopping guidelines should be outlined in the application and consent form.
- the PI or Co-I meet regularly to assess the safety and efficacy of the study. PI or Co-Is must ensure strict monitoring of stopping rules, participant withdrawals, and oversite during data collection.
For multi-site studies, this function could be managed by the team of PIs for each site or the lead PI for the entire research study.
Investigators may find using an independent expert or team of experts is helpful in monitoring multi-site research.
High Intensity Monitoring is required for research involving significantly greater than minimal risk.
In addition to the activities described above in low to moderate intensity monitoring, the PI or Co-I monitors the study on a day-to-day basis. Most high-risk protocols will require a DSMB to monitor the safety and efficacy of the study. An independent DSMB is required by NIH Guidelines for all Phase III clinical trials.
COUHES determines during initial and continuing review that the research plan includes adequate provisions for monitoring the data collected to ensure the safety of participants. Data Safety Monitoring Boards are requested for specific research on a case-by-case basis commensurate to the level of risk, size, complexity, study population and study type.