SQA Startup 4 — Questions and Answers
Question 1: When randomizing animals to treatment groups at study startup, which practice best supports GLP data integrity?
- Assign animals by visual appearance
- Use a documented, reproducible randomization method with recorded assignments (Correct answer)
- Let technicians choose based on preference
- Randomize after dosing begins
Correct answer: Use a documented, reproducible randomization method with recorded assignments
A documented and reproducible randomization procedure ensures unbiased group assignment and supports audit traceability.
Question 2: What does 'facility qualification' mean in the context of GLP study startup?
- Obtaining a business license
- Confirming the facility has been inspected and is appropriate for the study type (Correct answer)
- Completing the final report at the facility
- Sponsoring an FDA workshop
Correct answer: Confirming the facility has been inspected and is appropriate for the study type
Facility qualification confirms that the physical environment, utilities, and containment capabilities meet GLP and study-specific requirements.
Question 3: A Study Director is asked to sign a protocol that contains undefined parameters. What is the correct GLP response?
- Sign and clarify parameters verbally during the study
- Refuse to sign until all parameters are fully defined in writing (Correct answer)
- Sign and attach a memo to be filed separately
- Have a technician sign in the Study Director's absence
Correct answer: Refuse to sign until all parameters are fully defined in writing
The Study Director must not sign an incomplete protocol; all parameters must be clearly defined in writing before signature.
Question 4: Which startup documentation confirms that a computerized data system used in the study has been validated for its intended use?
- The system's purchase order
- The computer system validation (CSV) package (Correct answer)
- The sponsor's marketing brochure
- The raw data archive index
Correct answer: The computer system validation (CSV) package
A computer system validation package documents that the system performs as intended and meets GLP requirements for data integrity.
Question 5: During study startup, how should deviations from the protocol that occur before study initiation date be handled?
- Ignored because the study hasn't officially started
- Documented as protocol deviations and assessed for impact (Correct answer)
- Reported directly to the FDA without Study Director review
- Corrected silently with no documentation
Correct answer: Documented as protocol deviations and assessed for impact
Any deviations, even pre-initiation, must be documented and assessed to determine their potential impact on study validity.
Question 6: Which action is required when a new, untrained technician is added to the study team during the startup phase?
- Allow them to work under informal supervision only
- Provide and document appropriate training before they perform any study tasks (Correct answer)
- Assign them non-critical tasks without documentation
- Wait until the study ends to provide training
Correct answer: Provide and document appropriate training before they perform any study tasks
All study personnel must receive documented training appropriate to their tasks before performing any study-related activities.
Question 7: What is the significance of the 'experimental start date' in a GLP study, and how does it differ from the study initiation date?
- They are identical terms with no distinction
- The experimental start date is when the first study-specific data are collected; the initiation date is when the protocol is signed (Correct answer)
- The experimental start date is when the sponsor approves the budget
- The initiation date is when the archive receives documents
Correct answer: The experimental start date is when the first study-specific data are collected; the initiation date is when the protocol is signed
The study initiation date is defined by protocol signature, while the experimental start date marks when actual data collection (e.g., first dosing) begins.
SQA Startup 4
When randomizing animals to treatment groups at study startup, which practice best supports GLP data integrity?