Description of Content:

 This session will identify the roles, responsibilities, and strategies of the sponsoring investigator and the lead site in conducting a multi –center study. 

Objectives

• Define the term,  Investigator Initiated Trial
• Describe an organizational framework of a multi - center investigator initiated study
• Outline the functional responsibilities of a lead site
• Explain how Good Clinical Practice and Good Business Practice are similar
• Understand the difference between required lead site operations and services tendered to affiliate sites