SQA Startup 4

Question 1

When randomizing animals to treatment groups at study startup, which practice best supports GLP data integrity?

Accepted Answer

Use a documented, reproducible randomization method with recorded assignments

Answer

Assign animals by visual appearance

Answer

Let technicians choose based on preference

Answer

Randomize after dosing begins

Question 2

What does 'facility qualification' mean in the context of GLP study startup?

Accepted Answer

Confirming the facility has been inspected and is appropriate for the study type

Answer

Obtaining a business license

Answer

Completing the final report at the facility

Answer

Sponsoring an FDA workshop

Question 3

A Study Director is asked to sign a protocol that contains undefined parameters. What is the correct GLP response?

Accepted Answer

Refuse to sign until all parameters are fully defined in writing

Answer

Sign and clarify parameters verbally during the study

Answer

Sign and attach a memo to be filed separately

Answer

Have a technician sign in the Study Director's absence

Question 4

Which startup documentation confirms that a computerized data system used in the study has been validated for its intended use?

Accepted Answer

The computer system validation (CSV) package

Answer

The system's purchase order

Answer

The sponsor's marketing brochure

Answer

The raw data archive index

Question 5

During study startup, how should deviations from the protocol that occur before study initiation date be handled?

Accepted Answer

Documented as protocol deviations and assessed for impact

Answer

Ignored because the study hasn't officially started

Answer

Reported directly to the FDA without Study Director review

Answer

Corrected silently with no documentation

Question 6

Which action is required when a new, untrained technician is added to the study team during the startup phase?

Accepted Answer

Provide and document appropriate training before they perform any study tasks

Answer

Allow them to work under informal supervision only

Answer

Assign them non-critical tasks without documentation

Answer

Wait until the study ends to provide training

Question 7

What is the significance of the 'experimental start date' in a GLP study, and how does it differ from the study initiation date?

Accepted Answer

The experimental start date is when the first study-specific data are collected; the initiation date is when the protocol is signed

Answer

They are identical terms with no distinction

Answer

The experimental start date is when the sponsor approves the budget

Answer

The initiation date is when the archive receives documents

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