NIH Data Safety Monitoring Plan Information and Templates
To assist investigators in complying with the NIH data safety monitoring policy, please visit guidance and sample DSMP templates on the NIH website.

See also:

• NINDS Glossary of Clinical Research Terms
• FDA Guidance for Clinical Trial Sponsors
• NIH Policy for Data and Safety Monitoring
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
• Webinar: Oversight of Clinical Investigations

National Institute of Diabetes and Digestive and Kidney Diseases (NDDK):  

• Generic DSMP for studies requiring a DSMB
• Generic DSMP for studies not requiring a DSMB

DSMP Guidelines from Various NIH Institutes:

• National Cancer Institute (NCI)
• National Eye Institute (NEI)
• National Center for Complementary and Alternative Medicine (NCCAM)
• National Institute of Child Health & Human Development (NICHD)
• National Heart, Lung and Blood Institute (NHLBI)
• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Mental Health (NIMH)
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institute of Neurological Disorders and Stroke (NINDS)

National Cancer Institute

• Data and Safety Monitoring Guidelines
• Data and Safety Monitoring Example Plans

Need assistance or have clinical study management questions? Request a CTSI Study Design & Implementation Consultation