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Description:
Using the OECD Advisory Document No. 11 and 21 as the foundation, this course takes you through the responsibilities of the sponsor in the conduct of GLP studies. It is suitable for Sponsors, Test Facility Management and Study Directors.
On completion you will be able to discuss the responsibilities of the Sponsor and their direct and indirect involvement in studies.
Curriculum:
- Introduction
- Lesson 1
- Responsibilities of the Sponsor
- Use of the studies
- Lesson 2
- Characterisation of the test item
- Storage and retention of records and materials
- Lesson 3
- Direct involvement in GLP studies
- Indirect involvement in GLP studies
- Conclusion
- Final Assessment
- Certification