Page 120 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A013 SOP Title: Service Order Worksheet (SOW)
5. SPECIFIC PROCEDURE
5.1 Feasibility for Internally Funded Trials
5.1.1 Prior to initiating a SOW, RA leadership will complete a Mission Review (see A012) to appraise the merit of the science and impact on child health.
5.1.2 Once RA leadership has determined that a study is both mission aligned and feasible, the study team will initiate the SOW by sending the study documents and request to the appointed QS, and Research.Finance@Childrens.com.
5.1.3 The study team along with their team lead will develop a CTS (see RXXX) and follow process to obtain director approval.(Please, note during reopening, RA guidance should be followed with regard to completing the request for starting a new study. See attached guidance for more information).
5.1.4 Once the CTS is approved, the director will send it to appointed QS and a copy will be filed in the designated PI folder on the shared drive per process.
5.1.5 The study team will also work with their team lead to complete a feasibility analysis and sustainable enrollment plan (see Cornerstone Resources for Study Feasibility).
5.2 Establish for Internally Funded Trials
5.2.1 Upon receipt of the SOW request, the appointed QS will review the essential documents,
the feasibility, and CTS to draft a SOW.
5.2.1.1 The appointed QS will review the SOW with the study team and ancillary teams (including PI) for accuracy and clarification.
5.2.1.2 The appointed QS will review the SOW with the director and/or senior director for approval of the resources required in support of the protocol.
5.2.1.3 Once the SOW is approved by the director and/or Senior director, the appointed QS will send it to the RF for pricing.
5.2.1.4 Once RA leadership and RF review and approve the final SOW, the SOW can be routed for PI and VP signatures and finally executed with an official start date.
5.2.2 TheSOWwillbestoredandmaintainedbytheappointedQSonthedesignatedPI’sfolder on the shared drive.
5.3
Maintain for Internally Funded Trials
5.3.1 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).
5.3.2 The study team will use their checklists and continue to process improve or incorporate modifications to the financial management plan upon protocol amendments.
5.3.3 Thestudyteam,appointedQS,RAleadership,andRFwillassesseachprotocol amendment to follow steps 5.2.1 through 5.2.1.4 to amend the contract, budget, and SOW as applicable.
5.3.4 Additionally,forstudiesthatarefundedthroughinternalfunds(e.g.,SPG,MissionGrant, CCRAC) the study team should track the amount of approved time each cycle and report it to RF in Time Tracker. Once the amount of time remaining on the SOW is at ≤ 75 hours, the study team should communicate this to the director.
5.3.5 The director will appraise the funds remaining on the SOW and proactively consider the options for either a continuation or a transition of study management to support remote work from RA.
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