Study Management and Documentation Flashcards

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

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

21 CFR 58.185 specifies required final report contents including facility information, study dates, methods, all results, and the QAU compliance statement.

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

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

GDP requires contemporaneous dating, meaning dates must reflect when the observation actually occurred — retroactive dating is a GLP violation.

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

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

The QAU must inspect the final study report prior to submission to ensure it accurately reflects the raw data and that the GLP statement is included.

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

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

Specimen labels must carry enough information to uniquely link each specimen to its study, source animal, and collection event.

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

Answer: Calibration and maintenance records

Calibration and maintenance records prove that equipment was operating within validated parameters during the study period.

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

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

Missing or incomplete raw data undermines GLP compliance and can result in regulatory rejection of the study findings.