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STANDARD OPERATING PROCEDURE Research Administration SOP No: A013 SOP Title: Service Order Worksheet (SOW)
5.6.3.4 With RA’s approval of the contract and budget, the appointed Children’s Health Legal and Contracts representatives will execute the CTA with the VP as the authorizing signatory.
5.6.4 WithRAleadershipapprovaloftheSOW,theappointedQSwillroutetheSOWtothe PI and VP for signatures and execution.
5.6.5 TheSOWwillbestoredandmaintainedbytheappointedQS,theappointedQS,onthe designated PI’s folder on the shared drive.
5.7 Maintain for Industry Sponsored Trials Officed Internally
5.7.1 UponCTAandSOWapproval,thestudyteamwillworkwiththeirteamleadandrespective Financial Analyst (FA) to complete the EPIC set-up, (time) tracking and RBR management (see AXXX and AXXX for entering orders in EPIC and reconciling charges in EPIC RBR).
5.7.2 The study team will use their checklists and continue to process improve or incorporate modifications to the financial management plan upon protocol amendments.
5.7.3 Thestudyteam,theappointedQS,RAleadership,andRFwillassesseachprotocol amendment to follow steps 5.2.1 through 5.2.1.4 to amend the contract, budget, and SOW as applicable.
5.7.4 Additionally,thebudgetmayberenegotiatedovertime(i.e.,everytwoyears)toupdatethe budget to the current fee schedule.
5.8 Close-Out for Industry Sponsored Trials Officed Internally
5.8.1 Uponnoticeofstudyclosure,thestudyteamshouldnotifytheteamleadforconfirmation that the study closeout checklist has been completed.
5.8.2 Uponsaidconfirmation,thestudyteamshouldreachouttotheirrespectiveFAtoconfirm that all invoices have been made and reimbursed per SOW.
5.8.3 UponconfirmationfromRF,thestudyteamcanproceedtoclose-outthestudyand prepare for long term storage (see AXXX).
5.8.4 RFandRAleadership,andChildren’sHealthandContractswilldocumentthestudy contract and budget close-out.
6. STANDARDS/FORMS/TEMPLATES TO BE USED
6.1 Checklist (Appendix X)
The SOW process is can be supported with the use of a SOW checklist to ensure all elements required in support of the study have been met.
6.2 Building your Budget (Appendix X)
A guide is provided to support a study team member’s review of the SOW. The SOW will be developed by the appointed QS.
Training Offered in Cornerstone Research 101
Overview of Research Billing Reconciling Research Charges Service Order Agreements
NCD 310.1
Relevant Children’s Policies
CP 7.04 Clinical Research Cost Allocation
CP 7.06 Initiation of Research
CP 7.12 Responsibilities of the Research Team
CP 7.14 Research Accounting
CP 7.37 Research Planning, Initiation, and Charging
Fee Schedule 2020
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