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Navigable Slide Index

1. Introduction
2. Planning
3. Prescriptive documents
4. Examples of prescriptive documents
5. Study plan
6. Pivotal document
7. GLP requirements for contents - study director
8. GLP requirements for contents - proposed dates
9. GLP requirements for contents - useful dates
10. Approval / review of the study plan
11. Amendments to the study plan
12. GLP requirements for amendments
13. Master schedule definition
14. Regulatory inspectors' requests
15. Master schedule list
16. List necessity (1)
17. List necessity (2)
18. List necessity (3)
19. Compiling the master schedule
20. Archiving master schedule
21. Recording
22. Descriptive documents definition
23. Examples of descriptive documents
24. Raw data: definition
25. Before data recording
26. During data recording
27. Data should show "What"
28. Data should show "How"
29. Data should show "When"
30. Data should show "Who"
31. ALCOA (1)
32. ALCOA (2)
33. ALCOA (3)
34. Data management
35. Sample form
36. Carousel loading
37. Data audit trail
38. Archives
39. What should be retained in an archive?
40. Source of data generated
41. Retaining data in the archive
42. Associated documentation
43. Study related documentation
44. Environmental data
45. Concentric series
46. Archive function (1)
47. Archive function (2)
48. Archive function (3)
49. Designated manager
50. Movement of material into the archive
51. Archives submission form
52. Occasional retrieval of material
53. History of document
54. Retrieval (1)
55. Retrieval (2)
56. SOP - security
57. Conditions which minimise deterioration
58. Archive indexing
59. Electronic archiving
60. Archive duration (1)
61. A reminder of data retained
62. Archive duration (2)
63. Data type and archive duration
64. Licence for sale and archive duration
65. Some potential difficulties in archiving
66. Discarding archived data
67. Acknowledgements and thanks

Topics Covered

• Prescriptive documents
• Study plan
• Pivotal document
• GLP requirements for contents and amendments
• Master schedule
• Regulatory inspectors' requests
• Descriptive documents
• Raw data
• Before and during data recording
• ALCOA
• Data management
• Carousel loading
• Data audit trail
• Source of data generated
• Retaining data in the archive
• Associated documentation
• Environmental data
• Concentric series
• Archive function
• Designated manager
• Movement of material into the archive
• Retrieval of material
• History of document
• SOP-security
• Conditions which minimise deterioration
• Archive indexing
• Electronic archiving
• Data type / Licence for sale and archive duration
• Difficulties in archiving
• Discarding archived data

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on September 22, 2013

Financial Disclosures

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