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Source Review

A detailed illustration of a research team reviewing clinical trial documents, highlighting elements like case report forms, delegation of authority logs, and digital platforms like CRIO and Monday.com, in a professional office setting.

Source Review Quiz

Test your knowledge on the critical aspects of Source Review in quality assurance! This quiz is designed to enhance your understanding of the key components involved in the Source Review process.

7 Questions covering essential topics
Multiple choice and checkbox formats
Score your understanding of key concepts

7 Questions2 MinutesCreated by InspectingEagle202

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

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