IDRG: Huddle Questions in a Puzzle

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Across
  1. 1. Medication being tested in a clinical trial
  2. 4. Medical record system used by many hospitals
  3. 5. Independent group protecting study participants
  4. 6. Participant identification number
  5. 8. Plan to describe study procedures and visits
  6. 9. Person who oversees site research activities
  7. 10. Calendar of required study events
  8. 14. Departure from study defined requirements
  9. 16. Secure location where trial documents are stored
  10. 18. Inspection by a regulatory authority
  11. 21. Change made after protocol approval
  12. 24. Institution conducting the research
  13. 26. Agency that regulates drugs in the United States
  14. 28. Written record of original observations
  15. 31. Final step when a study ends at a site
  16. 32. Review of data and participant safety
  17. 33. Systematic review of trial conduct
  18. 37. Person responsible for the study at a site
  19. 39. Process of confirming eligibility before enrollment
  20. 40. Sponsor representative who reviews sites
Down
  1. 2. Record of study drug dispensing
  2. 3. Regulatory document required before study begins
  3. 7. Ethics committee review frequency
  4. 11. Person enrolled in a clinical trial
  5. 12. Person who organizes study activities
  6. 13. Clinical trial phase before approval
  7. 15. Person who reviews safety information
  8. 17. Final dataset used for statistical analysis
  9. 19. Organization overseeing multiple sites
  10. 20. Unexpected medical occurrence
  11. 22. Record documenting staff responsibilities
  12. 23. Likelihood that a result occurred by chance
  13. 25. Participant's agreement to join a study
  14. 27. List of questions completed by study participants
  15. 29. Participant privacy law
  16. 30. Drug given for comparison
  17. 34. Study instruction document
  18. 35. Committee monitoring participant safety
  19. 36. Laboratory result outside normal limits
  20. 38. International ethical standard for clinical research