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