Federal Guidance

• Code of Federal Regulations Title 45 Part 46 (Protection of Human Subjects)
• FDA Policy for Data and Safety Monitoring
• OHRP Guidance on Continuing Review

NIH Guidance documents on DSMPs/DSMB

The NIH requires a DSMB for Phase III clinical investigations (or any multi-site clinical trial) involving interventions that entail potential risk to participants. For Phase I and II trials, a DSMB may be appropriate if the studies have multiple clinical sites, are blinded or employ particularly high-risk interventions or vulnerable populations.

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

NIH Institute Specific Data and Safety Monitoring Guidance

• NCCAM Data and Safety Monitoring Guidelines for NCCAM-Supported Clinical Trials
• NCI: Policy of the National Canceer Institute for Data and Safety Monitoring of Clinical Trials
• NCI Conducting Clinicial Trials - Data and Safety Monitoring
• NEI: National Eye Institute Guidelines for Data and Safety Monitoring of Clinical Trials
• NHLBI Policy on Human Subjects Research Data and Safety Monitoring Plans
• NHLBI Guidelines for Data Quality Assurance in Clinical Trials and Observational Studies
• NHLBI Responsibilies of Data and Safety and Safety Monitoring Boards Appointed by Participating Institutions
• NIA: Implementation of Policies for Human Intervention Studies
• NIAAA Guidelines for Data and Safety Monitoring Plans
• NIAID: Decision Tree for Data and Safety Monitoring Plan
• NIAMS:Generic Monitoring Plan for Trials Requiring a Data Safety Monitoring Board
• NIAMS: Data and Safety Monitoring Guidelines for Investigator-Initiated Clinical Trials
• NICHD Policy For Data And Safety Monitoring
• NIDA: Guidelines for Developing a Data and Safety Monitoring Plan
• NIDCD: Data and Safety Monitoring of Clinical Trials Policies and Procedures
• NIDCR:Guidelines for Data and Safety Monitoring of Clinical Trials
• NIDDK: Data and Safety Monitoring Policy
• NIEHS: Data and Safety Monitoring Policy
• NIMH Policy on Data and Safety Monitoring in Clinical Trials
• NINDS: NIEHS Data and Safety Monitoring Policy
• NINR Generic Data Safety and Monitoring Plan for Clinical Trials Not Requiring a Data Safety and Monitoring Board