Clinical trials must be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. NIAMS has standardized procedures and provides templates to ensure compliance and the safety of human subjects.

Data and Safety Monitoring Guidelines and Policies.
Guidelines for oversight and monitoring of clinical trials to ensure the safety of participants and the validity and integrity of the data.

Clinical Study Tools & Templates.
Tools and templates for developing a manual of operating procedures to facilitate consistency across study participants and site.

NIH and Other Federal Guidelines/Policies for Clinical Research.
Mandatory policies and guidance for studies involving human subjects.

Last Reviewed: 03/09/2017