If a study is more than minimal risk and involves an intervention, a data and safety monitoring plan must be included in the proposal. For a submission for initial review, the Data and Safety Monitoring Plan information must be provided in the New Pprotocol Submission xForm. If you need assistance with developing your plan or selecting an appropriate study monitor, please contact the Vice Provost for Research at 423-439-6000.
What is minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological or tests (45 CFR 46.102 and 21 CFR 56.102).
Note: Studies involving prisoners have a different definition of minimal risk.
Who decides if the study is minimal risk?
The IRB (usually the IRB Chair) makes the final determination. Studies that are determined to be more than minimal risk are "full" studies and require review by the convened board.
- Studies in which a subject will be experimentally assigned to an investigational drug or device treatment intervention are considered to be more than minimal risk.
- Other studies may also be determined to be more than minimal risk.
- Contact the IRB office for questions.
What is data and safety monitoring?
Data and safety monitoring is the process for reviewing data from an ongoing study to monitor the progress of the research and the safety of participants.
The frequency of review and the intensity of the monitoring required depend on factors such as the study risk, complexity, and size.
What should be included in the plan?
There is a template plan available on our website under Forms and Templates. Your plan should include the following:
- Description of how risks are minimized and how risks are reasonable in relation to anticipated benefits and the importance of the knowledge that is expected to result
- The type of data or events that will be monitored
- Who will be monitoring the data/events
- How events will be reported
- How often the assessments will be made
- What procedures are in place to ensure protocol adherence
Considerations:
- Prompt detection of unanticipated problems involving risks to subjects or others
- Data accuracy
- Protocol compliance
- Recruitment, accrual, retention
- Criteria for suspension or termination of study
- Who will be monitoring the data/events?
- Is there a Data and Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) that will be monitoring the data/events? (for example, if the study is part of a multi-center clinical trial) If so, the DSMB/DMC generally will fulfill the requirement for a data and safety monitoring plan.
- Who will be monitoring and collection the adverse events?
- How will events be reported?
- Time frame for reporting unanticipated problems involving risks to the subjects or others to the sponsor, IRB, etc.
- If a study is multi-center and the local PI is the lead investigator, describe how communication will be assured among the sites
- If the study has DSMB/DMC, how findings will be reported to the IRB
- Plan for reporting of adverse events at continuing review, how often assessments will be made?
- When assessments will be made, (for example, after a certain number of participants are enrolled or at a specific point in the study)