Test item means an article that is the subject of a study. The test item may be a synthetic chemical, or a living organism. Test management are responsible for ensuring that test items are appropriately characterised.

Test system means any biological, chemical or physical system or combination thereof used in a study and is typically what the test item is applied to e.g rats in an animal toxicology study.

Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.

It is sometimes referred to as the protocol. Management is responsible for ensuring that there is documented approval of the study plan by the Study Director.