SQA Study Management and Documentation 2

Question 1

What is the key difference between a 'protocol deviation' and a 'protocol amendment' under GLP?

Accepted Answer

A deviation is an unintended departure from the protocol; an amendment is a planned, authorized change to the protocol

Answer

Deviations are unplanned departures from protocol requirements, while amendments are prospective, authorized changes approved before implementation.

Question 2

Under GLP, which individual is required to sign and date the final study report to certify its accuracy?

Accepted Answer

Study Director

Answer

The Study Director must sign and date the final report, certifying that it accurately reflects the raw data and that the study was conducted in compliance with GLP.

Question 3

What is required when computerized systems are used to collect GLP raw data?

Accepted Answer

Validation of the system, access controls, audit trails, and backup procedures

Answer

GLP computerized systems must be validated, protected with access controls, equipped with audit trails, and backed up to ensure data integrity.

Question 4

Under GLP, what is the requirement for documentation of test article receipt at the test facility?

Accepted Answer

A receipt record documenting identity, quantity, date received, and storage conditions

Answer

GLP requires written receipt documentation capturing identity, quantity, receipt date, and storage conditions for all test articles.

Question 5

Which GLP document must list all personnel involved in a study along with their qualifications and training?

Accepted Answer

Personnel training records maintained at the test facility

Answer

GLP requires that personnel training and qualification records be maintained at the facility to demonstrate that all study personnel are competent to perform their assigned tasks.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Study Management and Documentation 2