Good Practice Policies and Procedures (GPPP)

1. Notation and terminology
2. Ethics
3. Funding
4. Public access
   
   
5. Sample size
6. Bias control
7. Variance reduction
8. Stratification
   
   
9. Drug labeling and distribution
10. Randomization
11. Randomization override
12. Masking
    
    
13. Laboratory, reading, and banking
14. Substudy, ancillary study, and auxiliary study
    
    
15. Screening and eligibility
16. Enrollment
    
    
17. Forms design
18. Data collection
19. Data entry
20. Data processing
    
    
21. Training, certification, quality control, and quality assurance

22. IRB
23. Consent/assent
24. Adverse event reporting
    
    
25. Startup
26. Followup
27. Close-out
    
    
28. Conflict of interest disclosure and redress
29. Treatment effects monitoring
30. Treatment effects monitoring committee
    
    
31. Analysis
32. Publication and presentation
    
    
33. Administration
34. Organization
35. Operations
36. Meetings
37. Numbered memos
38. Study e-mail
39. Record retention and storage
    
    
40. Generic

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