Page 163 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

BOOK 2 OF 2: SECTION 3 Quality & Compliance
OVERVIEW OF SECTION CONTENT
Q001 Research Department Mailbox Process
Q002 Lapsed IRB Study Process
Q003 COG Performance Site Review and Approval
Q004 PSA Process (Full Board)
Q005 PSA Process (Expedited/Exempt)
Q006 RA Quality and Financial Reviews
Q007 MOD Approval Notification Process
Q008 Expanded Access/ Compassionate Use
Q009 Integrify
Q010 PSA Process for External IRB Projects
Q011 Facility Use Agreements
Q012 Service Order Agreement Process
Q013 Revising with SOAs Modifications
Q014 Performance Site Review Rejections
Q015 PSR Study File Management Plan
Q016 Standard Review Process
Q017 Pre-Trial Feasibility Assessment
Q018 Assessing/Requesting Ancillary Support
Q019 Non-Regulated Research
Q020 Adult Research Patients at Children’s Health
Q021 FDAAA 801, The Final Rule
Q022 Data Requests
Q023 Internet-Based Monitoring of Non-EPIC
Research Data
Q024 Study Close-Out Procedure
Research Administration
2022