SQA Startup 2 — Questions and Answers
Question 1: During a GLP study startup, which document must be finalized before any study-specific procedures begin?
- The final study report
- The signed study protocol (Correct answer)
- The audit certificate
- The raw data archive
Correct answer: The signed study protocol
GLP regulations require the signed study protocol to be in place before study-specific procedures commence.
Question 2: What is the purpose of a 'pre-study audit' conducted by a QA unit during startup?
- To verify final data integrity
- To confirm sponsor payment schedules
- To review protocol and facility readiness before work begins (Correct answer)
- To archive completed raw data
Correct answer: To review protocol and facility readiness before work begins
A pre-study audit ensures the protocol is sound and the facility, equipment, and personnel are prepared before study initiation.
Question 3: When a test facility receives a study sponsor's protocol amendment during startup, what is the FIRST action required under GLP?
- Archive the amendment without review
- Implement changes immediately without documentation
- Review, approve, and sign the amendment before proceeding (Correct answer)
- Notify the EPA only
Correct answer: Review, approve, and sign the amendment before proceeding
Protocol amendments must be reviewed, approved, and signed by the Study Director before any amended procedures are implemented.
Question 4: Which of the following best describes 'study initiation date' under GLP guidelines?
- The date the sponsor signed the contract
- The date the Study Director signs the protocol (Correct answer)
- The date the final report is issued
- The date raw data archiving begins
Correct answer: The date the Study Director signs the protocol
The study initiation date is defined as the date the Study Director signs the study protocol.
Question 5: During startup, a laboratory discovers that a required piece of equipment is out of calibration. What must occur before the study proceeds?
- Document the issue and continue as planned
- Replace the equipment with any available substitute
- Calibrate, verify accuracy, and document before use (Correct answer)
- Notify the sponsor and await their decision
Correct answer: Calibrate, verify accuracy, and document before use
GLP requires that all equipment be calibrated and verified as fit for purpose before it is used in a study.
Question 6: Who is responsible for ensuring that all study personnel are adequately trained before study startup under GLP?
- The QA unit exclusively
- The study sponsor
- The Study Director (Correct answer)
- The archive manager
Correct answer: The Study Director
The Study Director is responsible for ensuring all personnel involved in the study have appropriate training, experience, and qualifications.
Question 7: Which startup activity ensures that the test system (e.g., animals, cells) meets the protocol specifications before study procedures begin?
- Data reconciliation
- Final report preparation
- Test system acclimation and characterization (Correct answer)
- Archiving of study records
Correct answer: Test system acclimation and characterization
Acclimation and characterization confirm the test system's health, identity, and suitability prior to experimental procedures.
SQA Startup 2
During a GLP study startup, which document must be finalized before any study-specific procedures begin?