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Navigable Slide Index

1. Introduction
2. Background
3. Definitions
4. Responsibilities of management
5. Test facility management responsibilities
6. Test site management responsibilities
7. Study director responsibilities (1)
8. Study director responsibilities (2)
9. Study director responsibilities (3)
10. Principal investigator responsibilities (1)
11. Principal investigator responsibilities (2)
12. Principal investigator responsibilities (3)
13. Principal investigator responsibilities (4)
14. Principal investigator responsibilities (5)
15. Responsibilities of the study personnel
16. Responsibilities of the lead quality assurance
17. Responsibilities of test site quality assurance
18. Sponsor responsibilities (1)
19. Sponsor responsibilities (2)
20. Multi-site studies
21. Communication
22. Master schedules
23. Study plan (1)
24. Study plan (2)
25. Study plan (3)
26. Study plan - field studies
27. Performance of the study - field studies
28. Contaminating specimens
29. Storage areas
30. Facilities that handle test and reference items
31. Field studies - characterisation
32. Field studies - documentation
33. Field studies - waste disposal
34. Field studies - test systems
35. Multi-site studies - equipment
36. Study materials control and accountability
37. Control and accountability during transport
38. Material / data transfer
39. Reporting of study results (1)
40. Reporting of study results (2)
41. Standard operating procedures (SOP)
42. SOP parameters
43. Storage and retention of records / materials
44. References
45. Thank you

Topics Covered

• Conduct of multi-site and field studies in compliance with the OECD Principles of GLP
• Context, issues and complexities
• Responsibilities of test facility and test site personnel and sponsor
• Importance of communication
• Master schedule requirements for test sites
• Study plan requirements (with special reference to flexibility required for field studies)
• Performance of the study (with special reference to general facilities and to facilities for handling test and reference items and documentation required for field studies)
• Equipment, control and accountability of study materials for multi-site studies
• Reporting of study results
• Standard Operating Procedures
• Archives

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Dr. Geetha Rajashekhar has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.