Page 176 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q003
SOP Title: COG Performance Site Review / Approval Process
Quality Specialists (QS)
• Following receipt and confirmation of the above:
o QualitySpecialists(QS)willreviewallstudydocumentsfor
consistency across all submitted forms, including the eIRB SmartForm o PI and study coordinator will be made aware of any inconsistencies in
the documents
o If there are no inconsistencies in the documents, an email will be sent
to Children’s Health Medical Director for approval
• Approval will be granted in the Velos system under the Study Status tab
following receipt of fully executed administrative service order agreement.
5. SPECIFIC PROCEDURE 5.1 Process for COG studies
• A PSA application for a COG project is submitted in Velos by a member of CCBD
• QS will update the Velos status to “Performance Site – Received-Pending Review”
• QS will print all pertinent documents including the PSA, DOA, IRB application and all supporting forms
• QS will review/verify research personnel for credentialing and required research training
• QS will review the CIRB application, Protocol, ICF/HIPAA for general consistency
• QS will formulate questions and review them with the Research Administration management, if necessary
• A fully executed administrative SOA must be in place before the study can be routed for site approval.
• For studies that have IRB approval, QS will submit an email notification to Medical Director indicating administrative review/approval of COG study (Fast Track approach). Members of Research Administration will need to be copied on the email request to Medical Director. For non-IRB approved COG studies, PSA approval will be granted subsequent to IRB approval and receipt of FE SOA.
• A follow-up email will be sent to members of the CCBD research team indicating administrative fast track approval along with request for follow-up to questions and documents, including the pricing list.
• In the e-mail notification, QS will inform members of the research team (PI, RC, CCBD Manager) to communicate with the RA Research Finance team regarding any recruitment and visit activities for COG studies that have pending pricing lists and/or have not been created in REVEAL. The intent behind this request is to avoid any research charges being linked to the patient’s standard of care finance account (Medicaid, Private Payer, etc.)
• For studies that have not received IRB approval, a request is made to update the QS regarding IRB approval.
• Following receipt of IRB approval, Velos status will be updated to “Approved”.
SOP No. 1, Date: 4/13/16; revised 5/3/16, 7/5/16; 8/2/16; 10/13/16; 03/18/19; 04/03/20; 08/19/21, 05/31/22