The Good Laboratory Practice Study - The One Rule
The ONE rule is a useful way of remembering the key requirements of a study:
- ONE unique identity to separate it from all other studies - the study number
- ONE Study Director so it is clear who is the single point of control, and responsible for the technical validity and the Good Laboratory Practice compliance of the study
- ONE approved and definitive study plan that covers the whole scope of the study - available to all study personnel and Quality Assurance personnel
- ONE approved and definitive final report
