Page 23 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-001 SOP Title: Overview of Study Start-Up
file the Lab approval letter, the Lab Director’s CV and license, CAP, CLIA, and department Note to File documenting that lab personnel are not included on the DOA logs. Please, also file the department Note to File regarding study personnel to be included in Box 6 of the 1572 as applicable.
8. Build a CRC manual with all SOURCE documents and supportive materials and information to carry-out the study.
9. Review the start-up checklist with the team lead and ensure that they are included in Velos and eIRB as “other study personnel”. Please, be prepared to review the regulatory and CRC binders prior to holding a PACT meeting with your study team.
10. Upon obtaining and documenting all milestones on the Milestone Report, work with the sponsor to complete the site initiation visit (SIV) (see SOP titled Sponsor Communications).
11. Upon PSA approval and sponsor activation, update the study status in Velos setting to “Active and Enrolling”(see SOP Study Registration) and contact Research.Finance@Childrens.com and cc your financial analyst to build your study accounting record and activate your study in EPIC (observe alpha split by your PI’s last name).
For Study Coordination Team Members who are Not Permitted to move forward with Study Start-Up prior to obtaining a SOA in observance of the No SOA No Work rule and Policy CP:7.12; CP 7.37):
1. Ensure that you have forwarded the new study requests to the respective department representative in section 5.1 for research conducted by PIs employed through UTSW copying your CHST RA director and team lead; studies conducted by PIs who are employed through Children’s should be forwarded to CHST RA director and team lead. Please, forward all requisite documents and upload them into the documents tab of Velos (see SOP titled Initiating a CTA).
2. Work with your team lead and PI to complete study feasibility assessment Including laboratory questionnaire and coordinator time sheet (CTS).
3. Develop study funding agreement following the procedures defined in the SOP titled Securing Reimbursement for Your Study and CTS.
Upon securing a fully executed SOA:
4. Concurrently submit eIRB smartform and performance site approval (PSA)
(see SOPs titled Study Submissions and Performance Site Approval).
5. Address all stipulations and queries from the quality specialist and IRB in a timely fashion and anticipate actions items in order to minimize time delays.
6. Ensure the study team is credentialed, has completed GCP training, has been trained for the study, and has provided all essential documents and delegated their appropriate study tasks on the delegation of authority (DOA) log (see Sop titled Study Logs).