Page 163 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q006
SOP Title: Research Administration Quality and Financial Reviews
• Two days prior to the scheduled Quality Review, Quality Specialist will send an email to confirm the scheduled date, time, and location of the Quality Review with the PI and RC, and confirm with the Financial Specialist the participant(s) to be reviewed.
• One to two days prior to the scheduled Quality Review, Quality Specialist will prepare a virtual file with the following categories:
o CopyofemailNoticetothePI/RCandanyresponses
o TemplateQualityReviewRegulatorytoolandtemplateQualityReview
Subject Chart tool to be filled out during the review o Subjectresearch/documentation
o eIRB/VELOSstudydocuments
▪ eIRBandVelosstudydocumentsthatwillbereviewed:
• 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 QualityReviewRegulatorytoolwillbecompletedasmuchaspossible from the eIRB and VELOS study documents
o QualityReviewSubjectCharttoolwillbecompletedasmuchaspossible from EPIC and a thorough review of the protocol and schedule of treatment
DAY BEFORE QUALITY REVIEW:
Email the PI and Coordinator confirming the Quality Specialist(s) is coming the next day for the Quality Review
DAY OF QUALITY REVIEW / Quality Specialist:
• Meet the Coordinator at the designated location o ReviewRegulatorybinder(s)
o Reviewcollecteddata
o Forprospectivestudies,reviewchart/sourcedocuments
o Forretrospectivestudies,reviewdatacollectionformandverify
against approved protocol
SOP No. 4 Revised, Date: 04/12/18, 07/24/18; 08/17/21