Study Plan - The Contents
The OECD Principles of Good Laboratory Practice provide a minimum list of contents for the study plan. Additional detail is often needed to make the study plan understandable and prevent mistakes occurring.
Using the outline specification of the study from the Sponsor:
- Resources must be allocated
- Materials must be assembled
- Methodology must be agreed
The study plan will then be written to include:
- A descriptive title
- A statement which reveals the nature and purpose of the study
- The identification of the test item
