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

A deviation requires sponsor approval; an amendment does not

Answer

A deviation is documented in the QAU statement; an amendment is verbal only

Answer

A deviation is serious; an amendment is minor

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

Quality Assurance Unit Manager

Answer

Sponsor

Answer

Test Facility Management

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

A paper printout of all data at the end of each day

Answer

Sponsor certification of the software version

Answer

QAU signature on each electronic data file

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

A verbal confirmation to the Study Director

Answer

Only a storage log once the article is placed in inventory

Answer

An email from the sponsor confirming shipment

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

The study protocol

Answer

The final report appendix

Answer

The QAU inspection log

Question 6

Under GLP, how should multiple samples from the same animal or subject be differentiated in raw data?

Accepted Answer

By unique individual identification such as animal number, sample code, or collection time

Answer

By weight only

Answer

By cage position

Answer

By the technician's initials