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