Page 21 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-001 SOP Title: Overview of Study Start-Up
5.2 No Service Order Agreement (SOA)/ No Work Rule: Pre Award Activities
Once a study assignment has officially been made and the introductory meeting has taken place (see SOPs titled Making Study Assignments; Coordinating the Introductory Meeting with the PI), the study funding condition should be considered in order to move forward in compliance with the No SOA/ No Work Rule (see SOP titled Securing Reimbursement for your study). The study funding condition includes observance of 1) the PI’s employment, 2) the study coordination team member’s employment and funding mechanism, and 3) the funding mechanism of the study itself. If the study coordination team does not meet the criteria to move forward directly to Study Start-Up (see next section), there are Pre-Award Activities that are permitted under the No SOA/ No Work Rule that the study coordinator (CRC) or (CRA) can move forward with prior to obtaining SOA approval.
1. If a confidentiality disclosure agreement (CDA) has not yet been completed, please follow the steps:
a. Submit CDA form and protocol synopsis to appropriate legal department contact for review (please refer to section 5.1).
2. Observe the No SOA/No Work Rule
3. Engage in Pre-Award Activities:
a. Feasibility Assessment
b. Review Protocol
c. Complete Coordinator Time Sheet (see SOP titled Securing Reimbursement for Your Study)
d. Complete laboratory feasibility review
e. Submit SOA request to the appropriate UTSW Contracts or Sponsored Programs Administration (SPA) as appropriate (see section 5.1 above).
f. Engage in reviewing and revising the SOA and Coverage analysis when engaged by the quality specialist assigned to your study.
4. Upon obtaining approval from RA Director, the CRC or CRA should complete the following activities at nearest opportunities as the following activities are required, rate-limiting factors:
a. For Industry Sponsored Studies: Connect the sponsor’s legal representative with the director of RA initiating a request for a Facility Use Agreement (FUA). The FUA is important is indemnifying CHST against liability should the conduct of the trial per the sponsor’s instruction ensue any liability.
b. Credentialing: In observing relevant CHST policies, every study team member must be credentialed prior to site approval and their involvement or commencement in the study.
a. For Non-Medical Personnel: Submit the team member’s information requesting credentialing to- Medical_Education@Childrens.com cc: Mike Molai
b. For Medical Personnel: Submit the team member’s information requesting credentialing to- Children's Health Medical Staff Services CVO@childrens.com cc: Katie Elder and Mike Molai