Startup Flashcards

During a GLP study startup, which document must be finalized before any study-specific procedures begin?

Answer: The signed study protocol

GLP regulations require the signed study protocol to be in place before study-specific procedures commence.

What is the purpose of a 'pre-study audit' conducted by a QA unit during startup?

Answer: To review protocol and facility readiness before work begins

A pre-study audit ensures the protocol is sound and the facility, equipment, and personnel are prepared before study initiation.

When a test facility receives a study sponsor's protocol amendment during startup, what is the FIRST action required under GLP?

Answer: Review, approve, and sign the amendment before proceeding

Protocol amendments must be reviewed, approved, and signed by the Study Director before any amended procedures are implemented.

Which of the following best describes 'study initiation date' under GLP guidelines?

Answer: The date the Study Director signs the protocol

The study initiation date is defined as the date the Study Director signs the study protocol.

During startup, a laboratory discovers that a required piece of equipment is out of calibration. What must occur before the study proceeds?

Answer: Calibrate, verify accuracy, and document before use

GLP requires that all equipment be calibrated and verified as fit for purpose before it is used in a study.

Who is responsible for ensuring that all study personnel are adequately trained before study startup under GLP?

Answer: The Study Director

The Study Director is responsible for ensuring all personnel involved in the study have appropriate training, experience, and qualifications.

Which startup activity ensures that the test system (e.g., animals, cells) meets the protocol specifications before study procedures begin?

Answer: Test system acclimation and characterization

Acclimation and characterization confirm the test system's health, identity, and suitability prior to experimental procedures.