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

A documented and reproducible randomization procedure ensures unbiased group assignment and supports audit traceability.

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

Facility qualification confirms that the physical environment, utilities, and containment capabilities meet GLP and study-specific requirements.

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

The Study Director must not sign an incomplete protocol; all parameters must be clearly defined in writing before signature.

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

A computer system validation package documents that the system performs as intended and meets GLP requirements for data integrity.

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

Any deviations, even pre-initiation, must be documented and assessed to determine their potential impact on study validity.

SQA - Society of Quality Assurance Practice Test