Clinical Research Team Structure (Page 13)

Appendix A: Clinical Research Team Structure (Page 13)

The Clinical Research Team Structure image illustrates the hierarchical organization and roles within a clinical research team. The structure is designed to ensure efficient management and execution of clinical trials. Here is a detailed description of the image:

Regulatory (ICH, FDA) is in a black box positioned at the top center of the hierarchy with the Sponsor and Contract Research Organization branching out directly below in gray boxes. Underneath is the Medical Director in a spruce green box with a Coordination Center beige box branching out below and to the left that includes purple boxes with Regulatory sStaff, Fiscal management and a Project Manager. Branching out below and to the right is the Data Coordinating Center in the same style beigh box as the Coordination Center that includes Data Manager, Statistician and Monitor in mustard yellow boxes.

The next tier on the structure has the Principal Investigator in a lime green box positioned at the top middle of this next level of hierarchy with the Grants Manager, Sponsored Programs, IRB and CCRM/CTO Management Teams listed next to it in pink boxes. 

Below this tier are gray arrows that show a back and forth connection with the Principal investigator lime green box is a row of teal boxes that include, from left to right, Research Assistant, Nurses, lab Tech, Clinical Research Coordinator, Sub-investigators and Pharmacist. 

Directly below these teal boxes is one sky blue box with an arrow showing the back and forth relationship with Subjects.