Page 123 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)
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BOOK 2 OF 2: SECTION 3
Quality & Compliance
2021
Pre-Trial Feasibility Assessment Assessing/Requesting Ancillary Support Non-Regulated Research
OVERVIEW OF SECTION CONTENT
Q001
Q002
Q003
Q004
Q005
Q006
Q007
Q008
Q009
Q010
Q011
Q012
Q013
Q014
Q015
Q016
Q017
Q018
Q019
Q020
Q021
Q022
Q023
Research Data
Q024 Study Close-Out Procedure
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
Adult Research Patients at Children’s Health FDAAA 801, The Final Rule
Data Requests
Internet-Based Monitoring of Non-EPIC
Research Administration
