Data Safety Monitoring Plans
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.
OSU Data Monitoring Policy
http://orrp.osu.edu/irb/osupolicies/documents/DataandSafetyMonitoring.pdf
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
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
Further NIH Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
