Study Management and Documentation Flashcards

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

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.

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

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.

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

Answer: Standard Operating Procedure (SOP)

SOPs are written instructions that describe how routine procedures are performed, ensuring consistency and traceability.

How must superseded (outdated) SOPs be handled under GLP?

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Superseded SOPs must be archived with documentation of when they were replaced, to support reconstruction of historical study conduct.

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

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.

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

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.