Across
- 2. System that tracks investigational product dispensing and returns (abrv)
- 4. Characteristics or conditions that prevent someone from participating in a research study
- 8. Final freeze of trial data at study end (abrv)
- 9. To assign subjects by chance
- 11. Independent committee that monitors ongoing clinical trials to ensure subject safety and data integrity oversees participant safety and trial integrity(abrv)
- 12. Blinding helps prevents this in clinical trials
- 14. Study phase that focuses on safety, tolerability, and dose-finding in a small group of healthy participants
Down
- 1. Governing document for study conduct
- 3. Clinical site visit to ensure sites are trained and ready to conduct the trial according to the protocol and GCP
- 4. Specific, measurable outcomes used to determine whether the intervention being studied is effective or safe
- 5. Document that outlines how statistical analysis will be performed(abrv)
- 6. Summarizes all known clinical and nonclinical data about the Investigational Product (abrv)
- 7. Electronic capture of subject level data (abrv)
- 10. Committee that reviews and approves research to ensure participant safety and ethical conduct (abrv)
- 11. Occurs when a subject misses a required assessment/subject visit
- 13. To confirm source CRF entries match original source records(abrv)