Page 151 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A017 SOP Title: Virtual Office Navigator
5.1.3 Once, you have established means to fund your research, use the built in links to initiate services.
5.1.4 Work with the respective Research Administrative representative to complete the process required to support your research.
5.2 Appraising Services to Support Research: SERVICES
Once you have determined your research and the funding allocated to support it (contact Research_Department.Research_Department@childrens.com and Research.Finance@Childrens.com for informational support), follow the below steps on the FORMS tab and Survey the Resources on the SERVICES tab.
5.3 Obtain Study Budget & Contract: FINANCES
Pre-Award Activities:
5.3.1 Review the SOP titled Securing Reimbursement for Your Study located on the FORMS tab to:
5.3.1.1 Determine the correct study funding agreement to support the study
5.3.1.2 Engage the Key Personnel involved in obtaining your funding agreement
5.3.1.3 Navigate the process of obtaining a study funding agreement. Observe the No SOA/ No Work Rule.
5.3.2 Go to the FINANCES tab and follow the processes for relevant pre-award study milestones.
5.3.3 If applicable, initiate a clinical trial agreement (CTA).
5.3.4 If applicable, initiate a coverage analysis (CTCA).
5.4 Obtain Regulatory Approvals: REGULATORY
Once you have determined your research and the funding allocated to support it (contact Research_Department.Research_Department@childrens.com and Research.Finance@Childrens.com for informational support), follow steps 5.1 through 5.3.
5.4.1 Once you have secured a method of reimbursement for your study, contact the Team Leads for guidance on pre-award activities.
5.4.2 Once you have secured a method of reimbursement for your study, initiate a request for guidance on using UTSW IRB. Also, if your study is a multisite study and will rely on another IRB, please contact Research_Department.Research_Department@childrens.com .
5.4.3 Once you have secured a method of reimbursement for your study, if the principal investigator for your study is employed through Children’s Medical Center, you may submit a request to have your study reviewed at IntegReview.