SQA Startup 5

Question 1

Which scenario at study startup would trigger a formal protocol amendment rather than a minor administrative correction?

Accepted Answer

Changing the dose levels or duration of treatment

Answer

Changes that affect the scientific conduct of the study, such as dose levels or duration, require a formal signed protocol amendment.

Question 2

In GLP, what is the required outcome if a test article mixture is prepared at study startup and homogeneity cannot be confirmed?

Accepted Answer

Do not use the mixture until homogeneity is analytically confirmed

Answer

Homogeneity of test article mixtures must be analytically verified before administration to ensure dose accuracy and data validity.

Question 3

A QA inspector discovers that the study protocol was signed after the first day of dosing. Which GLP principle has been violated?

Accepted Answer

The requirement that the protocol be signed before study-specific procedures begin

Answer

GLP mandates that the Study Director sign the protocol before study-specific procedures commence; signing after dosing begins is a serious GLP violation.

Question 4

Which of the following best describes a 'startup meeting' in the context of a GLP study?

Accepted Answer

A pre-study meeting to align all personnel on protocol requirements, roles, and responsibilities

Answer

A startup meeting ensures all study personnel understand their roles, the protocol, and GLP expectations before work begins.

Question 5

Under GLP, if the sponsor requests that certain startup documentation remain confidential, what obligation does the test facility still have?

Accepted Answer

Maintain all required GLP records and make them available to regulatory inspectors

Answer

Regardless of confidentiality agreements, all GLP-required records must be retained and made available to regulatory authorities upon request.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Startup 5