Page 19 - 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
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the process and procedures for establishing a clinical with Children’s Health System of Texas (CHST) as the primary site when the principal investigator (PI) of the trial is employed externally.
2. INTRODUCTION
In line with our institutions’ strategic priorities of quality and efficiency, Research Administration (RA) has integrated the appropriate policies and procedures with references to additional regulations and informational support in an overview of study start-up. The care taken to ensure that clinical research trials are established in a manner that ensures patient safety, as well as facilitates the success of the trial while operating within the legal and regulatory parameters is a key focus of our mission to grow research and advance medical practice.
3. SCOPE
The current document applies to all those who conduct clinical research at CHST.
4. RESPONSIBILITIES
4.1 Study Coordination Team Assignment
Every research study must run through the appropriate channels in order to ensure that the study coordination assignment is accurately defined in the proper study agreement and congruently accounted for in the study budget. Making adequate study assignments includes consideration of the experience, licensure, funding, current workload and PI preference for the clinical research coordinator (CRC) or associate (CRA).
4.2 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.
4.3 Study Start-Up
Study start-up is demarcated by a series of ordered milestones (see Milestone Report) all of which serve to ensure patient safety, comply with governing legal and