Page 175 - 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
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed by Research Administration for a twenty-four hour turnaround Cancer Oncology Group (COG) Performance Site Approval (PSA), at the time of PSA submission.
2. INTRODUCTION
Research Administration requires a twenty-four hour turnaround for COG PSAs using a standard process of reviewing the information. From here forward, this process will be referred to as the “COG Performance Site Approval Process” (CPSAP).
For other cross-functional processes, it is good practice and common expectations within the Children’s Health and from industry best practice that procedures must be in place to ensure the accountability, traceability, and consistency of the research approval development process.
3. SCOPE
This SOP applies to Research Administration and associated ad hoc participants to the CPSAP .
CPSAP documentation consists of IRB documents, credentialing and training requirements of study personnel, emails and financial documentation.
4. RESPONSIBILITIES
4.1 Members of CCBD
For a twenty-four hour approval turnaround time, members of CCBD will contact Quality Specialists by phone/email in order to apprise them of a COG PSA submission in Velos.
Items to be requested, completed and/or uploaded in Velos at time of PSA submission:
• Completed PSA submitted in Velos addressing each question
• 1572, if applicable, uploaded in Velos under the “Documents” tab
• Request the Department of Paediatrics Grants & Contracts specialists to
initiation of a service order agreement to capture billable charges
• Completed Delegation log, uploaded in Velos under the “Documents” tab
• All study team members verified as credentialed according to hospital policy
• All study team members verified as completing Children’s Research modules
• Excluding the financial and support staff, study team members listed in the
eIRB, delegation log, and PSA form must be consistent
NOTE: A delay in the approval may result if any of the above is not provided as part of the initial PSA submission.
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