SQA Startup 2

Question 1

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

Accepted Answer

The signed study protocol

Answer

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

Question 2

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

Accepted Answer

To review protocol and facility readiness before work begins

Answer

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

Question 3

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

Accepted Answer

Review, approve, and sign the amendment before proceeding

Answer

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

Question 4

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

Accepted Answer

The date the Study Director signs the protocol

Answer

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

Question 5

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

Accepted Answer

Calibrate, verify accuracy, and document before use

Answer

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

SQA - Society of Quality Assurance Practice Test