PREFACE Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The goal of the DSMP is to provide a general description of a plan that you intend to

A. Introduction These requirements and guidelines created by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) detail the safety reporting processes that investigators are required to follow when conducting NIAMS-supported clinical research studies. These studies include clinical trials and other types of clinical research studies e.g., observational

Learn about the NIH and NIAMS policies and requirements for Data and Safety Monitoring (DSM), guidelines for creating a Data and Safety Monitoring Plan (DSMP), risk assessment and determination of monitoring type, types of monitoring bodies NIAMS may consider, and much more. Additional reporting requirements, such as the Institutional Review