Regulatory Core
Overview
The Regulatory Core works in partnership with study team members to successfully navigate the clinical research regulatory landscape throughout the lifecycle of a study. The primary goal of the core is to ensure the safety of research subjects participating in studies conducted at MSM.
Services Include
- IRB preparation and submission assistance
- Assist with the maintenance of regulatory master files for research studies
- Aid in the development of protocol-specific standard operating procedures
- Identify quality risks and issues and create appropriate corrective action plans
- Conduct periodic internal reviews to ensure protocol compliance
- Administer training on federal regulations and guidance documents