Startup Flashcards

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

Answer: Use a documented, reproducible randomization method with recorded assignments

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

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

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

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

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

Answer: Refuse to sign until all parameters are fully defined in writing

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

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

Answer: The computer system validation (CSV) package

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

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

Answer: Documented as protocol deviations and assessed for impact

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

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

Answer: Provide and document appropriate training before they perform any study tasks

All study personnel must receive documented training appropriate to their tasks before performing any study-related activities.

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

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

The study initiation date is defined by protocol signature, while the experimental start date marks when actual data collection (e.g., first dosing) begins.