Other terms and concepts

pre-analytical errors, chain of custody, LIMS, CAP, and endpoints

Q: What is a pre-analytical error?

A: An error that occurs before lab analysis

Q: What is chain of custody in sample handling?

A: A documented record of every person who handles a sample from collection to analysis.

Q: What is a LIMS?

A: Laboratory Information Management System – software used to track samples

Q: What does CAP stand for in lab accreditation?

A: College of American Pathologists – provides accreditation and quality assurance programs.

Q: What is CLIA?

A: Clinical Laboratory Improvement Amendments – US regulations that ensure lab testing quality.

Q: What is an EQA scheme?

A: External Quality Assessment – a program where external samples are sent to labs to test accuracy and comparability.

Q: What is a primary endpoint?

A: The main outcome measured in a clinical trial to determine treatment effect.

Q: What is a secondary endpoint?

A: An additional outcome used to evaluate other effects of a treatment.

Q: What is an exploratory endpoint?

A: A research question in a trial that is not powered for formal testing but may generate future hypotheses.

Q: Give an example of a pre-analytical factor that can affect RNA quality.

A: Delay in freezing

Q: Why is proper sample labeling important?

A: To prevent mix-ups and ensure traceability from patient to data.

Q: What does calibration mean in a lab context?

A: Adjusting equipment to ensure accuracy by comparing against a known standard.