Page 119 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A013 SOP Title: Service Order Worksheet (SOW)
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to describe the process for establishing a service order worksheet (SOW) for services incurred for research at Children’s Health.
2. INTRODUCTION
Alongside our institution’s strategic priority of growth, our institution must be reimbursed for the services it provides. All research conducted at Children’s Health supported by internal funds, such as a grant awarded by the Children’s Clinical Research Advisory Committee (CCRAC), mission grant, or service package grant (SPG); or by funds otherwise officed in- house through the establishment of a clinical trial agreement (CTA) between an external sponsor and Children’s Health, will require a SOW to define the internal flow of funds. A SOW is an internal worksheet outlining the resources and relative charges required for a given study by use of internal funds, or funds otherwise officed at Children’s Health.
3. SCOPE
This SOP applies to those who seek to establish a SOW for research conducted at Children’s Health including the study coordination team, quality specialists, finance, leadership, and the Children’s Health Legal and Contracts departments.
4. RESPONSIBILITIES
The establishment, maintenance and close-out of SOWs are managed interdependently across the study team, appointed research administration (RA) quality specialist (QS), RA leadership, research finance (RF) manager, and a representative of the legal and contracts departments when applicable. In some cases, a coverage analysis and CTA negotiation are supported by an external partner, PFS Clinical. All SOWs will be approved by the RA Director(s) and RF teams. The RA Vice President is the only authorizing signatory. Please, see Table 1 for an outline of the responsibilities related to SOW by phase of study and across positions.
Table 1. Responsibilities Related to SOW by Phase of Study and Across Position
Study Team Quality Specialist Children’s Health & Team Leads Legal & Contracts
Leadership & Finance
Feasibility
CTS/Director Approval Feasibility Analysis
Review CTS/ Feasibility/ CTCA
Review Mission Merit Financial Feasibility
Establish
Collaborate in SOW Draft
Complete SOW Draft
Obtain Director Approval
RF Pricing/Approval
Route for Signatures (post-CTA)
Draft CTA with Sponsor Incorporate CTCA
RA Leadership Review Gain Sponsor Approval Route for Signatures
Review/Approve SOW Execute SOW - Vice President Execute CTA- Vice President
Maintain
Track Expiration of SOW Submit Modifications Financial Management:
Order Entry EPIC RBR Time Tracking
Process Modifications Process Modifications
Maintain CTA Compliance Process Modifications Process Research Invoices Track AR
Close-Out
Get RF Clearance to Close-Out
Document Update CTA Close-Out SOW Close-Out
Balance Research Account Report Mission Outcomes