Investigators must develop a data and safety monitoring plan to ensure the welfare of human subjects.

NIAMS Data and Safety Monitoring Guidelines

Guidelines and activities for data and safety monitoring (DSM). The DSM body may be comprised of an independent Safety Officer (SO) or a committee, also known as a data and safety monitoring board (DSMB).

See the full Data and Safety Monitoring Guidelines

How to Write a Data and Safety Monitoring Plan, Word Version (DOC – 75 KB)

How to Write a Data and Safety Monitoring Plan

A guide for writing a Data and Safety Monitoring Plan, including the type of monitoring body (e.g. DSMB, OSMB or SO); responsibilities of study staff and monitoring body; procedures for data review and reporting for adverse events; and contents and format of the safety reports.

See the full How to Write a Data and Safety Monitoring Plan Guide

Principal Investigator Responsibilities Related to NIAMS-appointed Data and Safety Monitoring Boards

Responsibilities of the clinical study Principal Investigator with respect to a Data and Safety Monitoring Board (DSMB), which provides ongoing, independent study review and assures the study is conducted according to the highest scientific and ethical standards.

See the complete list of Principal Investigator Responsibilities

Data and Safety Monitoring Board Charter

A document that outlines the NIAMS charge to the Data and Safety Monitoring Board regarding its responsibilities, composition, and processes for a clinical trial.

See the full DSMB Charter Template

Guidelines for Reporting to a Safety Officer

Requirements for reporting data and safety monitoring to an independent Safety Officer, used for small, single-site clinical trials with low risk.

See the full Guidelines for Reporting to a Safety Officer

More Information

NIH Policy Concerning Data and Safety Monitoring (released on June 10, 1998)

Further Guidance on Data and Safety Monitoring for Phase I and II Trials (released on June 5, 2000)

Last Reviewed: