Page 22 - 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
c. Standard Review (Technology Review): Every study involving device that will potentially connect to CHST’s network must complete a systematic review of security of devices for research. Submit all relevant information pertaining to the device (e.g., specs, etc.) to StandardReview@childrens.com cc: Jeff.Blythe@Childrens.com and Mike.Molai@Childrens.com.
d. Lab Review: Complete the feasibility of the research processing lab to support the study as part of the pre-award activities and feasibility analysis. Subsequently, please, seek a lab approval letter and ensure that the lab requisition sheets, lab manual, and protocol along with the study Velos and IRB number - LabResearchAdmin@Childrens.com cc: Elias.Quintero@Childrens.com (214.456.6146) prior to study activation.
e. For all clinical devices, or equipment: It is required to have the device reviewed via the Standard Review process (see item c of this section). It is further required that Biomed inspect and register the equipment, and that the appoint study team member (if not the CRC), will provide a monthly attestation of the device and ensure it is kept in line with protocol and policy.
f. All technical devices or equipment: It is required to have the device reviewed via the Standard Review process (see item c of this section). It is further required that the equipment be registered (via 6-4636), and that the appoint study team member (if not the CRC), will provide a monthly attestation of the device and ensure it is kept in line with protocol and policy.
5.3 Study Start-Up
Prior to engaging in study start-up, the study coordination team member must meet the criteria defined by the No SOA/ No Work rule (see SOP titled Securing Reimbursement for Your Study; Service Order Worksheet).
For Study Coordination Team Members who are permitted to move forward with study start-up prior to obtaining a SOA:
1. Register Study in Velos (see SOP titled Velos Study Registration) and ensure that the clinical trial agreement (CTA) and coverage analysis (CTCA) are initiated in velos and all requisite documents are uploaded into the documents tab (see SOP titled Initiating a CTA).
2. Concurrently submit eIRB smartform and performance site approval (PSA) (see SOPs titled Study Submissions and Performance Site Approval).
3. Work with your team lead and PI to complete study feasibility assessment Including laboratory questionnaire and coordinator time sheet (CTS).
4. Develop study funding agreement following the procedures defined in the SOP titled Securing Reimbursement for Your Study and CTS.
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).
7. Ensure that the Regulatory Binder meets all requirements as defined by E6 ICH GCP Chapter 8 (see SOP titled Regulatory Binder). Additionally, please