Data and Safety Monitoring

NIH Policy and Guidance

• NIH Policy for Data and Safety Monitoring
• Data and Safety Monitoring for Phase I and Phase II Trials

Institute/Center Procedures and Guidance

National Cancer Institute (NCI)

• Data and Safety Monitoring Guidelines (PDF)

National Center for Complementary and Integrative Health (NCCIH)

• Data and Safety Monitoring of NCCIH-Funded Clinical Research
• Guidelines for NCCIH-Appointed Data and Safety Monitoring Boards 

National Eye Institute (NEI)

• NEI Guidelines for Data and Safety Monitoring of Clinical Trials 

National Heart, Lung, and Blood Institute (NHLBI)

• Data and Safety Monitoring Policy 

National Institute on Aging (NIA)

• Implementation of Policies for Human Intervention Studies 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

• NIAAA Guidelines for Data and Safety Monitoring Plans 

National Institute of Allergy and Infectious Diseases (NIAID)

• NIAID Research Using Human Subjects
• Trans-NIAID Clinical Toolkit
• NIAID Research Rules & Policies for Clinical Research, Genomic Data Sharing, Grants, and Contracts 

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

• NIAMS Data and Safety Monitoring Guidelines 

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• NICHD Policies for Data and Safety Monitoring 

National Institute on Drug Abuse (NIDA)

• NIDA Guidelines for Developing a Data and Safety Monitoring Plan 

National Institute on Deafness and Other Communication Disorders (NIDCD)

• NIDCD Guidelines for Data and Safety Monitoring of Clinical Trials 

National Institute of Dental and Craniofacial Research (NIDCR)

• NIDCR Clinical Research Oversight & Related Templates
• NIDCR Human Subjects Research Policies & Expectations
• NIDCR Clinical Terms of Award | Human Subjects Research
• Conducting NIDCR Clinical Research

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

• NIDDK Data and Safety Monitoring Policy 

National Institute of Environmental Health Sciences (NIEHS)

• NIEHS Policy for Data and Safety Monitoring of Human Subject Research Studies 

National Institute of General Medical Sciences (NIGMS)

• NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials 

National Institute of Mental Health (NIMH)

• NIMH Policy on Data and Safety Monitoring in Extramural Investigator-Initiated Clinical Trials 

National Institute of Neurological Disorders and Stroke (NINDS)

• NINDS Guidelines for Monitoring in Clinical Trials 

National Institute of Nursing Research (NINR)

• NINR Policy for Data and Safety Monitoring of Clinical Trials