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STANDARD OPERATING PROCEDURE Research Administration SOP No: A013 SOP Title: Service Order Worksheet (SOW)
5.4 Close-Out for Internally Funded Trials
5.4.1 Uponnoticeofstudyclosure,thestudyteamshouldnotifytheteamleadforconfirmation that the study closeout checklist has been completed.
5.4.2 Uponsaidconfirmation,thestudyteamshouldreachouttotheirrespectiveFAtoconfirm that all invoices have been made and reimbursed per SOW.
5.4.3 UponconfirmationfromRF,thestudyteamcanproceedtoclose-outthestudyand prepare for long term storage (see AXXX).
5.4.4 RFandRAleadership,andChildren’sHealthLegalandContractswilldocumentthestudy contract and budget close-out.
5.4.5 AttheendoftheMG/SPGfundedtrials,RFwillsendoutrequestsforaprogressreportto the PI.
5.4.6 OncethePIhasreturnedaprogressreport,theAdministrativeCoordinatorwillfilethe report and the MG/SPG will be considered closed.
5.5 Feasibility for Industry Sponsored Trials Officed Internally
5.5.1 Prior to initiating a SOW, RA leadership will complete a feasibility analysis to appraise the; 1) the safety and compliance relevant to the adequate storage and tracking of investigational product (e.g., risk classification of investigational and approved devices, and investigation drugs and biologics), and 2) financial and general feasibility.
5.5.2 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.
5.5.3 The study team along with their team lead will develop a CTS (see R006) and follow process to obtain director approval.
5.5.4 Once the CTS is approved, the director will send it to he appointed QS and a copy will be filed in the designated PI folder on the shared drive per process.
5.5.5 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).
5.5.6 If applicable, RA leadership will engage PFS Clinical to begin the CTCA.
5.6 Establish for Industry Sponsored Trials Officed Internally
5.6.1 Once the CTCA is completed and confirmed with RA Leadership and PI, PFS Clinical will send the CTCA and any sponsor preferred CTA terms and language to the appointed Children’s Legal representative to begin the legal review, development, and negotiation of the study CTA and budget language.
5.6.2 Upon receipt of the SOW request, the appointed QS will review the essential documents, the feasibility, and CTCA to draft a SOW.
5.6.2.1 The appointed QS will review the SOW with the study team and ancillary teams (including PI) for accuracy and clarification.
5.6.2.2 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.
5.6.3 PFS Clinical, in conjunction with RA Leadership and RF, will begin negotiating the budget with the sponsor utilizing the CTCA and SOW draft, and sponsor’s proposed budget.
5.6.3.1 (see CP 7.05 Research Rates) 30% overhead is applied to the itemized budget when RA is the financial manager and owner of the study budget and contract.
5.6.3.2 RA leadership, RF, PI, and sponsor will review and approve the final budget.
5.6.3.3 Once the budget is approved, PFS Clinical will support its integration in the CTA and the appointed QS and RF will revise the SOW to reflect the agreed upon terms of the CTA.
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