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