Source Review

What percentage of Source Review is QA Responsible for?
10%
20%
50%
100%
Which of the following are critical for Source Review
Case Report Forms
Protocol
IWRS Manual
Delegation of Authority
CRIO
Lattice
IRB
Wet-Ink source is uploaded to Monday.com
True
False
Wet-Ink source is uploaded to CRIO
True
False
Which of the following are Logs within CRIO that are carried throughout all visits within a subject's chart?
Protocol Deviations
Adverse Events
Concomitant Medication
Medical History
Vaccination History
Demographics
Laboratory Sampling
Informed Consent Checklist
Which of the following are examples of wet-ink source that might accompany a CRIO chart?
Informed Consent Form
IWRS Printout
eDiary Distribution
eDiary Activation
Laboratory Requisition Form
Laboratory Sample Receipt
Laboratory Sample Results
Blinded Investigational Product Administrations Form
Site Staff MUST be delegated on Delegation of Authority Log prior to carrying out a task
True
False
0
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