Monitoring and Compliance Support

Our experienced Education and Compliance Support (ECS) Coordinators provide local monitoring services to sponsors of clinical investigations, perform Research Investigator Start-up Education (RISE) reviews on newly approved IRB studies, and audits as requested by the IRB.

The Good Clinical Practice (GCP) Toolbox contains templates and documentation guidelines to assist investigators and staff with maintaining research records in compliance with the requirements outlined in the federal regulations. 

Monitoring Services

The ECS Coordinators provide local monitoring services to sponsors of clinical investigations that involve an IND or IDE under the jurisdiction of the IRB. 

GCP Toolbox

This Good Clinical Practice (GCP) Toolbox contains general guidance and study documentation tools.

RISE Review

Research Investigator Start-Up Education (RISE) review is an educational initiative that assists investigators and their teams with regulatory and ethical issues concerning their newly approved protocols.

Audits

Audits are conducted by the ECS-HSR Division at the request of the IRB or in response to a complaint from an employee or subject regarding the conduct of the study.