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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-001 SOP Title: Overview of Study Start-Up
regulatory parameters, and ensure that the study can be feasibly carried out and adequately covered in a comprehensive study budget contract agreement.
5. SPECIFIC PROCEDURE
5.1 Study Coordination Team Assignment
Requests for Study Coordination Support: University of Texas Southwestern Medical Center (UTSW)-
There are a number of entry points at the conception phase of a study. Upon an expressed study interest or official site selection, an official request for study coordination support should be made as outlined here:
• For studies whose PI is employed through the UTSW Pediatrics Department: pedsresearch@utsouthwestern.edu.
• For studies whose PI is employed through the UTSW Urology Department: Monica.Villagomez@UTSouthwestern.edu .
• For studies whose PI is employed through a UTSW Department other than the previously mentioned: please, see the contacts sections in the front of this book.
Requests for Study Coordination Support: CHST RA-
Once the study has been assessed for the type of study coordination support requires, the respective UTSW representative will contact the director of RA. The director will work with the team leads to assess and make the best study assignment to one of the study coordination team members (see SOP titled Making Study Assignments).
1. UTSW contacts the director of CHST RA with request
2. Director of RA works with team leads to assess the best candidate
3. When the circumstances permit, the team leads will hold a study allocation
meeting with the potentially affected study coordinators to inform a decision
that incorporates the preferences of the study team
4. Team leads make the study assignment meeting with the CRC or CRA
5. The team lead should arrange an introductory meeting with the PI and
assigned CRC CRA to assess:
a. Enrollment Goals and Windows
b. Feasibility and Funding and Resources
c. Site Study Personnel and Entities (relationships within entities for data
and completion of protocol activities)