Department of Epidemiology


              Coordinating Centers

    C.L. Meinert Memo Series

Good Practice Policies and Procedures (GPPP)
 

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  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

  1. Laboratory, reading, and banking

  2. Substudy, ancillary study, and
    auxiliary study

  3. Screening and eligibility

  4. Enrollment
     

  5. Forms design

  6. Data collection

  7. Data entry

  8. Data processing
  1. Training, certification, quality control,
    and quality assurance
  2. IRB
  3. Consent/assent
  4. Adverse event reporting
     
  5. Startup
  6. Followup
  7. Close-out
  8. Conflict of interest disclosure and
    redress
     
  9. Treatment effects monitoring
  10. Treatment effects monitoring
    committee
  11. Analysis
  12. Publication and presentation
     
  13. Administration
  14. Organization
  15. Operations
  16. Meetings
  1. Numbered memos
  2. Study e-mail
  3. Record retention and storage
  4. Generic