Research Data Management

Human Subjects Data

Data and Safety Monitoring Plans are designed to assure that each research study has a system in place for appropriate oversight and monitoring of the conduct and progress of the study that ensures:

1. Important information that may affect the safety or welfare of participants comes to light and is acted upon as quickly as possible, and
2. The validity and integrity of research data.

Data and Safety Monitoring Plans should be tailored to the risk level and complexity of the research. For clinical trials initiated by a research sponsor, the sponsor often includes the monitoring plan in the research protocol. For investigator-initiated studies, the researcher will need to establish an independent monitor or monitoring board to regularly review research data for participant safety. UC Davis Office of Research provides a charter template for establishing a Data and Safety Monitoring Board along with institutional guidance on Monitoring for Safety and Compliance.