Session11 - Investigator Site File's (ISF) - Developing, Implementing, and Maintaining a Site Standard

Description

This presentation includes the importance of quality file management at the site level via Investigator Site File(ISF) standards. The importance of this presentation is to illustrate standardization in large site file management practices as well as assurance for regulatory compliance. The audience will walk away with practical knowledge on the importance of a solid ISF standardization process as well as how to implement into their sites or improve current state of ISF management. The presentation will include a case observation from of a newly implemented ISF process at Children's Mercy Hospital.

Learning Objectives:

• Aknowledge the importance and implement a quality site wide Investigator Site File (ISF) process.
• Inspection/Regulatory Rediness
• Standardization of file maintenance

Speaker(s):

• Trevor Cole, BHS, MBA-HCM, CCRC, Research Quality Monitoring Program Manager, Children's Mercy Hospital