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Data Management

This guide is to help you prepare a data management plan.

Data & Safety Monitoring Plan

Data & Safety Monitoring Plan

Data and Safety Monitoring Plan (DSMP) is an individualized plan, written by the Principal Investigator (PI) responsible for the study. Federal regulations require a DSMP for projects that involve human subjects research that poses greater than minimal risk. The DSMP sets forth mechanisms for reviewing and evaluating unanticipated problems and other study-relevant data. The rationale for requiring a DSMP is the need to enhance research subject safety by clearly defining safety related issues prior to subjects being enrolled in a study. These issues include:

  1. Monitoring the safety of the environment including the safe handling of drugs, solutions, specimens, physical space, and equipment;
  2. Monitoring and protecting the validity and integrity of the data collected for the study; and
  3. Documenting, grading, attributing, and reporting unanticipated problems involving risks to subjects or others.

Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected.

Greater Than Minimal Risk includes research involving the use of drugs, biologics, or devices require a DSMP. For other types of interventional human subjects research involving greater than minimal risk, a DMSP should be strongly considered and may be required by the IRB.

Significantly Greater than Minimal Risk to subjects means that there is a probability of an event that is serious, prolonged and/or permanent occurring as a result of study participation or there is significant uncertainty about the nature or likelihood of adverse events. Trials with Significantly Greater than Minimal Risk require adequate protections for foreseeable adverse events.

Does Your Research Study Meet the Definition of a Clinical Trial?

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