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Description:
Using the OECD Advisory Document No. 13 as the foundation, this course takes you through the responsibilities of the sponsor, test facility management, quality assurance and Study Directors in the conduct of a GLP study which is conducted at more than one site.
On completion you will be able to use terminology related to multisite studies, discuss the responsibilities of key personnel, and the planning, conduct, reporting and archiving of multisite studies as the test facility.
Curriculum:
- Introduction
- Lesson 1
- Terminology
- Lesson 2
- Management and Control of Multisite Studies
- Lesson 3
- Quality Assurance
- Lesson 4
- Planning
- Conduct
- Reporting
- Archiving
- Conclusion
- Final Assessment
- Certification