With the release of the FDA Guidance "Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects" (October 2009), research sites have been challenged to critically review their current operating practices to determine the status of their site's compliance with the guidance. This presentation will discuss how a hospital based oncology practice operating with six satellite sites under a sole principal investigator has restructured its practice in order to increase compliance with the guidance document.
Describe the measures taken to ensure staff are adequately qualified.
Describe the process to ensure the coordination of data to ensure the principal investigator is able to oversee multiple sites of operation
Define metrics used to determine the level of oversight of satellite sites and implementation of the restructuring.