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
  1. IRB
  2. Consent/assent
  3. Adverse event reporting

  4. Startup
  5. Followup
  6. Close-out

  7. Conflict of interest disclosure and redress
  8. Treatment effects monitoring
  9. Treatment effects monitoring committee

  10. Analysis
  11. Publication and presentation

  12. Administration
  13. Organization
  14. Operations
  15. Meetings
  16. Numbered memos
  17. Study e-mail
  18. Record retention and storage

  19. Generic
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   Last updated:  04 November 2004