SQA Study Management and Documentation 1 — Questions and Answers
Question 1: Under GLP, what is the definition of 'raw data'?
- Any laboratory worksheets, records, memoranda, notes, or exact copies that are the result of original observations (Correct answer)
- Only electronic data generated by instruments
- Summary tables extracted from laboratory notebooks
- Final study report appendices
Correct answer: Any laboratory worksheets, records, memoranda, notes, or exact copies that are the result of original observations
GLP defines raw data broadly as any original record or exact copy of original observations made during a study.
Question 2: What is required when making a correction to a handwritten entry in GLP raw data?
- Draw a single line through the error, write the correction, date it, and initial it — never obliterate the original entry (Correct answer)
- Use white correction fluid to cover the error and rewrite above it
- Rewrite the entire page with the correction incorporated
- Cross out the error with multiple lines and write 'error' beside it
Correct answer: Draw a single line through the error, write the correction, date it, and initial it — never obliterate the original entry
GLP requires corrections to be traceable: a single strike-through preserves the original entry while the correction, date, and initials document the change.
Question 3: Which GLP document provides step-by-step instructions for routine laboratory operations to ensure consistency?
- Standard Operating Procedure (SOP) (Correct answer)
- Study protocol
- Final report
- Master Schedule Sheet
Correct answer: Standard Operating Procedure (SOP)
SOPs are written instructions that describe how routine procedures are performed, ensuring consistency and traceability.
Question 4: How must superseded (outdated) SOPs be handled under GLP?
- Retained in archives with the date of supersession noted (Correct answer)
- Destroyed immediately upon replacement
- Transferred to the sponsor for retention
- Stored in the active SOP binder alongside the current version
Correct answer: Retained in archives with the date of supersession noted
Superseded SOPs must be archived with documentation of when they were replaced, to support reconstruction of historical study conduct.
Question 5: What is the purpose of a 'study initiation date' under GLP?
- It marks when the first study-specific experimental data are collected, triggering retention period calculations (Correct answer)
- It marks when the protocol was signed
- It marks when the sponsor signed the contract
- It marks when test animals arrived at the facility
Correct answer: It marks when the first study-specific experimental data are collected, triggering retention period calculations
The study initiation date is defined as the date the first study-specific data are recorded, and it triggers GLP retention timeline requirements.
Question 6: Under GLP, what must be documented when personnel are delegated specific study-related responsibilities by the Study Director?
- A written record identifying the individual, their qualifications, and the specific responsibilities delegated (Correct answer)
- Only verbal communication witnessed by the QAU
- A signature in the protocol only
- An email confirmation from the sponsor
Correct answer: A written record identifying the individual, their qualifications, and the specific responsibilities delegated
GLP requires written documentation of all delegated responsibilities, including the delegate's identity and qualifications.
SQA Study Management and Documentation 1
Under GLP, what is the definition of 'raw data'?