The conduct of trial
The quality of the data produced
Compliance with Good Clinical Practice (GCP) and applicable regulations
All of the above
True
False
True
False
True
False
Centralized in one location
Robust metrics and reporting capabilities
Provides audit trails
All of the above
Regulatory
Quality Management
CRO
All of the above
FDA
MHRA
DEA
A and B
True
False
True
False
True
False
Study Team Training
Screening and Enrollment Log
Clinical Study Report
A and B
True
False
Content QC
Document (non-content) QC
Both A and B
None of the above
True
False
Nothing. The document is filed as-is.
The document is returned to the submitter to make corrections.
Document Management fixes the error and files the document.
None of the above.
True
False
Day one
When a site is initiated
When the study closes
When you receive notification of an inspection
Following Good Clinical Practice (GCP)
Relying solely on ICH GCP Essential Document List
Understanding the regulatory environment of the governing authority
A and C
True
False
Volunteer information.
Never ask the inspector to clarify their questions.
Only answer questions specifically related to your role.
B and C
True
False
Storyboard
Protocol
ICH GCP Section 8
All of the above
None of the above
Prospective QC
Retrospective QC
Oversight QC
A and C
All types are equally preferred.
True
False
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