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).
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.
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.
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.
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.