SQA Study Management and Documentation 2 — Questions and Answers
Question 1: What is the key difference between a 'protocol deviation' and a 'protocol amendment' under GLP?
- A deviation is an unintended departure from the protocol; an amendment is a planned, authorized change to the protocol (Correct answer)
- A deviation requires sponsor approval; an amendment does not
- A deviation is documented in the QAU statement; an amendment is verbal only
- A deviation is serious; an amendment is minor
Correct answer: A deviation is an unintended departure from the protocol; an amendment is a planned, authorized change to the protocol
Deviations are unplanned departures from protocol requirements, while amendments are prospective, authorized changes approved before implementation.
Question 2: Under GLP, which individual is required to sign and date the final study report to certify its accuracy?
- Study Director (Correct answer)
- Quality Assurance Unit Manager
- Sponsor
- Test Facility Management
Correct answer: Study Director
The Study Director must sign and date the final report, certifying that it accurately reflects the raw data and that the study was conducted in compliance with GLP.
Question 3: What is required when computerized systems are used to collect GLP raw data?
- Validation of the system, access controls, audit trails, and backup procedures (Correct answer)
- A paper printout of all data at the end of each day
- Sponsor certification of the software version
- QAU signature on each electronic data file
Correct answer: Validation of the system, access controls, audit trails, and backup procedures
GLP computerized systems must be validated, protected with access controls, equipped with audit trails, and backed up to ensure data integrity.
Question 4: Under GLP, what is the requirement for documentation of test article receipt at the test facility?
- A receipt record documenting identity, quantity, date received, and storage conditions (Correct answer)
- A verbal confirmation to the Study Director
- Only a storage log once the article is placed in inventory
- An email from the sponsor confirming shipment
Correct answer: A receipt record documenting identity, quantity, date received, and storage conditions
GLP requires written receipt documentation capturing identity, quantity, receipt date, and storage conditions for all test articles.
Question 5: Which GLP document must list all personnel involved in a study along with their qualifications and training?
- Personnel training records maintained at the test facility (Correct answer)
- The study protocol
- The final report appendix
- The QAU inspection log
Correct answer: Personnel training records maintained at the test facility
GLP requires that personnel training and qualification records be maintained at the facility to demonstrate that all study personnel are competent to perform their assigned tasks.
Question 6: Under GLP, how should multiple samples from the same animal or subject be differentiated in raw data?
- By unique individual identification such as animal number, sample code, or collection time (Correct answer)
- By weight only
- By cage position
- By the technician's initials
Correct answer: By unique individual identification such as animal number, sample code, or collection time
GLP requires that each sample be traceable to its source through unique identifiers that link specimen to animal and collection event.
SQA Study Management and Documentation 2
What is the key difference between a 'protocol deviation' and a 'protocol amendment' under GLP?