SQA Study Management and Documentation 3

Question 1

What must be included in a GLP final study report according to 21 CFR 58.185?

Accepted Answer

Name and address of facility, study initiation and completion dates, objectives, methods, results, and QAU statement

Answer

Only statistical summaries and conclusions

Answer

Study director's CV and sponsor contract details

Answer

Protocol only, with a reference to raw data location

Question 2

In GLP document management, what does 'Good Documentation Practices' (GDP) require when dating an entry?

Accepted Answer

Entries must be dated contemporaneously — on the same day the observation or action occurs

Answer

Dates may be added within 30 days of the observation

Answer

The Study Director may backdating entries during the final report preparation

Answer

Dates are required only for summary pages, not individual data entries

Question 3

Under GLP, when must the QAU conduct its inspection of the final study report?

Accepted Answer

Before the final report is submitted to the sponsor or regulatory agency

Answer

After the regulatory agency reviews the report

Answer

Within 30 days of study completion regardless of report status

Answer

Only when the sponsor requests a GLP audit

Question 4

What is the GLP requirement for specimen labels to ensure traceability throughout the study?

Accepted Answer

Labels must contain sufficient information to identify the specimen, including study number, animal ID, and collection date

Answer

Labels need only a sequential sample number

Answer

Labels must match the animal's physical tag color

Answer

Labels are not required for specimens stored at the facility longer than 6 months

Question 5

Under GLP, which type of record must be retained to demonstrate that a testing site's equipment was functioning correctly during the study?

Accepted Answer

Calibration and maintenance records

Answer

Animal care logs

Answer

Test article receipt records

Answer

Personnel training certificates

Question 6

What is the consequence of missing or incomplete raw data under GLP regulations?

Accepted Answer

The study may be considered non-compliant and data may be rejected by the regulatory agency

Answer

The Study Director must rerun the affected portion of the study

Answer

The QAU must notify the FDA within 30 days

Answer

The sponsor must certify that missing data does not affect conclusions