NIH Policy and Guidance

• NIH Policy for Data and Safety Monitoring
• Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multi-Center Clinical Trials
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

Institute/Center Policy and Guidance

NCI

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

NEI

• NEI Guidelines for Data and Safety Monitoring of Clinical Trials

NHLBI

• Data and Safety Monitoring Policy
• Establishing DSMBs and OSMBs

NIA

• Implementation of Policies for Human Intervention Studies

NIAAA

• NIAAA Guidelines for Data and Safety Monitoring Plans

NIAID

• NIAID Policy on Data and Safety Monitoring Board (DSMB) Operations (PDF)
• Create a Data and Safety Monitoring Plan
• Decision Tree for Data and Safety Monitoring Plan
– Division of Microbiology and Infectious Diseases
• Policy and Guidelines for Data and Safety Monitoring

NIAMS

• Data and Safety Monitoring Guidelines
• DSMB Charter

NICHD

• NICHD Policy for Data and Safety Monitoring

NIDCD

• Policy and Procedures for Investigator-initiated Clinical Trials
• Data and Safety Monitoring of Clinical Trials

NIDCR

• NIDCR Policy for Data and Safety Monitoring of Clinical Research

NIDDK

• NIDDK Data and Safety Monitoring Policy
• NIDDK Data and Safety Monitoring Guidelines for Clinical Trials
• Generic Data and Safety Monitoring Plan for Clinical Trials Not Requiring a Data and Safety Monitoring Board
• Generic Data and Safety Monitoring Plan for Clinical Trials Requiring a Data and Safety Monitoring Board

NIDA

• Guidelines for Developing a Data and Safety Monitoring Plan

NIEHS

• Clinical Research

NIMH

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

NINDS

• NINDS Guidelines for Data and Safety Monitoring in Clinical Trials
• Guidelines and Policies for Monitoring Clinical Research
• National Institute of Neurological Disorders and Stroke Extramural Guidelines for Monitoring Patient Safety in Clinical Trials

• Data and Safety Monitoring Guidelines for NCCAM Supported Clinical Trials