Data and Safety Monitoring

For research involving human subjects, federal regulations require that, when appropriate, research plans make adequate provisions for monitoring data to ensure the safety of research participants.

Research Data Policy at Ohio State

View the Ohio State Research Data Policy.

NIH Guidance

Investigators seeking National Institutes of Health funding should consult the NIH policy and guidance documents referenced below. Researchers are also advised to contact their program officer regarding the specific institute requirements that may include sponsor pre-review before Institutional Review Board submission.

• NIH Policy for Data and Safety Monitoring
• AHRQ Data and Safety Monitoring Policy
• Further NIH Guidance on Data and Safety Monitoring for Phase I and Phase II Trials

Additional Assistance

For further assistance contact Carson Reider, Clinical Research Consultant, Center for Clinical and Translational Science, carson.reider@osumc.edu , phone 293-9274.