Data & Safety Monitoring Questions/Answers
The Investigator designs and carries out research studies with adequate data and safety monitoring during the research, when appropriate.
Answers
Which Studies require a Data and Safety Monitoring Plan (DSMP) at UK?
A DSMP is required at Initial IRB Review for:
- Greater than minimal risk research
- NIH Funded Clinical Trial
- FDA-Regulated Clinical Investigation
Monitoring the progress of the research and the safety of participants are key components to a DSMP.
The IRB recognizes that the elements of a monitoring plan may vary depending on the potential risks, complexity, and nature of the research. After reviewing the plan, the IRB may determine that a formal DSMP is not necessary or find that monitoring by the investigator as proposed is adequate or could determine that the study requires an independent individual or independent body (i.e., Data and Safety Monitoring Board) for monitoring.
The ORI DSMP website provides guidance for developing a plan and guidance for when a Data and Safety Monitoring Board (DSMB) is warranted or required. NOTE: If relying on an independent agent or committee for DSMB services, (e.g., Center for Clinical and Translational Science DSMB), it is the PI’s responsibility to establish the services with the agent or committee.
What Data and Safety Monitoring information are you required to report to the IRB?
Reporting status and outcomes from Data and Safety Monitoring is essential for the IRB to decide if the criteria for approval is met at continuing review. The Principal Investigator (PI) is responsible for reporting on the status of the studies’ data and safety monitoring plan. ORI staff contact the PI at Continuing Review (CR), if a report is expected and not submitted. If the study has an independent Data and Safety Monitoring Board (DSMB) the PI should submit activity reports to the IRB upon receipt, through modification requests or continuing review submission.
