Page 147 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A017 SOP Title: Virtual Office Navigator
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the process and procedures for navigating the Virtual Research Office in pursuit of establishing research at Children’s Health System of Texas (CHST).
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 for navigating the Virtual Research Office and accessing the correct resources in support of your research. The care taken to facilitate research through the integration of the services available through Research Administration and in order that research 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 is relevant to all those who conduct clinical research at CHST. It is intended to help the administrators in supporting investigators navigate our SharePoint site and initiate their research.
4. RESPONSIBILITIES
4.1 Service Order Agreement (SOA) and Study Initiation
Being good stewards of our resources requires that every study that generates research related charges must have a defined funding mechanism in place to secure reimbursement (see SOP titled Securing Reimbursement for Your Study). Accordingly, the below activities are pre-award activities that are permissible to be completed prior to obtaining SOA approval.
1. Feasibility Assessment
2. Review Protocol
3. Complete a Coordinator Time Sheet
4. Laboratory Review
4.2 Pre-Study Initiation Requirements
Prior to beginning work on a research study at CHST, it is required to have a method of securing reimbursement for the services and fees rendered. This is referred to as the No SOA/ No Work Rule (see SOPs Titled Overview of Study Start-Up; and Securing Reimbursement for Your Study). Additionally, the following requirements must be completed prior to commencement of research study activities:
* pertains to clinical trials only
• Confidentiality Disclosure Agreement (CDA)
• *Site Evaluation Visit (SEV) and Feasibility Assessment
• Pre-Study Start-Up Activities
• Protocol Review
• Coordinator (CRC) Time Sheet
• Facility Use Agreement (FUA)
• Laboratory Review