SQA Study Management and Documentation

Question 1

Under GLP, what is the definition of 'raw data'?

Accepted Answer

Any laboratory worksheets, records, memoranda, notes, or exact copies that are the result of original observations

Answer

Only electronic data generated by instruments

Answer

Summary tables extracted from laboratory notebooks

Answer

Final study report appendices

Question 2

What is required when making a correction to a handwritten entry in GLP raw data?

Accepted Answer

Draw a single line through the error, write the correction, date it, and initial it — never obliterate the original entry

Answer

Use white correction fluid to cover the error and rewrite above it

Answer

Rewrite the entire page with the correction incorporated

Answer

Cross out the error with multiple lines and write 'error' beside it

Question 3

Which GLP document provides step-by-step instructions for routine laboratory operations to ensure consistency?

Accepted Answer

Standard Operating Procedure (SOP)

Answer

Study protocol

Answer

Final report

Answer

Master Schedule Sheet

Question 4

How must superseded (outdated) SOPs be handled under GLP?

Accepted Answer

Retained in archives with the date of supersession noted

Answer

Destroyed immediately upon replacement

Answer

Transferred to the sponsor for retention

Answer

Stored in the active SOP binder alongside the current version

Question 5

What is the purpose of a 'study initiation date' under GLP?

Accepted Answer

It marks when the first study-specific experimental data are collected, triggering retention period calculations

Answer

It marks when the protocol was signed

Answer

It marks when the sponsor signed the contract

Answer

It marks when test animals arrived at the facility

Question 6

Under GLP, what must be documented when personnel are delegated specific study-related responsibilities by the Study Director?

Accepted Answer

A written record identifying the individual, their qualifications, and the specific responsibilities delegated

Answer

Only verbal communication witnessed by the QAU

Answer

A signature in the protocol only

Answer

An email confirmation from the sponsor