Page 201 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q006
SOP Title: Research Administration Quality and Financial Reviews
• When the date for Quality Review is confirmed with the PI or research coordinator, add the study to the Quality Review Summary Tracking Report spreadsheet located on Children’s Research Administration SharePoint: https://dallaschildrens.sharepoint.com/:x:/r/teams/ResearchQualitySpecialistTeam /_layouts/15/guestaccess.aspx?email=ANDREW.HEBERT%40childrens.com&e= mYblq8&CID=58840693-C529-47A8-AE66- 0320322B3F04&wdLOR=cEED95944-BBB6-43EC-A7B1- 532D4C9D8D9B&share=EdBV3uH5BwRBtvyOQhleKi4BQw- 9r4zzVcWjrEg0xO9fnQ
• One to two days prior to the scheduled Quality Review, Quality Specialist will prepare a virtual file with the following categories:
o Copy of email Notice to the PI / RC and any responses
o TemplateQualityReviewRegulatorytoolandtemplateQualityReview
Subject Chart tool to be filled out during the review o Subjectresearch/documentation
o eIRB/VELOSstudydocuments
▪ eIRB and Velos study documents that will be reviewed:
• IRB approval letter
• Verification of study team members
• Training and Delegation logs
• Protocol(s)/Investigator Brochure – resource in eIRB
• Informed consent form(s) – resource in eIRB
• Historical approval(s) of study documents (MOD and CR)
• Any other pertinent document(s) that impacts the study
• After preparation of the e-file, a review of the study documents in the eIRB and Velos systems will be completed by the Quality Specialist(s)
o Quality Review Regulatory tool will be completed as much as possible from the eIRB and VELOS study documents
o Quality Review Subject Chart tool will be completed as much as possible from EPIC and a thorough review of the protocol and schedule of treatment
DAY OF QUALITY REVIEW / Quality Specialist:
• Meet the Coordinator at the designated location o ReviewRegulatorybinder(s)
o Reviewcollecteddata
o Forprospectivestudies,reviewchart/sourcedocuments
o For retrospective studies, review data collection form and verify
against approved protocol
SOP No. 4 Revised, Date: 04/12/18, 07/24/18; 08/17/21, 05/31/22