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Navigable Slide Index

1. Introduction
2. Roles and responsibilities
3. Defining the responsibilities of each person
4. Sponsor responsibilities
5. Sponsors must understand GLP requirements
6. Sponsor responsibilities when providing a test item
7. Sponsor responsibilities - study plan, final report
8. Sponsors - storage/retention of records/materials
9. Sponsors - submitting a regulatory file
10. Management responsibilities (1)
11. Management responsibilities (2)
12. Study director responsibilities (1)
13. Study director responsibilities (2)
14. Study director responsibilities (3)
15. Study director responsibilities (4)
16. Principal investigator responsibilities
17. Archivist responsibilities
18. Quality assurance
19. Documenting roles and responsibilities
20. Organisation chart
21. Organisation chart example
22. Personnel must have
23. Curriculum vitae (CV)
24. CV - recommendations
25. Job descriptions
26. Job descriptions - recommendations
27. Training records (1)
28. Training records (2)
29. Archive records
30. Acknowledgment

Topics Covered

• Responsibilities of Sponsors, Management, Study directors, Principal investigators, Archivists
• Storage/Retention of records/materials
• Quality assurance
• Documenting roles and responsibilities
• Organisation chart
• Curriculum vitae
• Job descriptions
• Training & Archive records

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Mr. David Long has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.