Across
- 1. Electronic capture of subject level data
- 4. To confirm source CRF entries match original source records
- 6. Governing document for study conduct
- 9. Summarizes all known clinical and nonclinical data about the IP
- 10. Primary or secondary outcomes
Down
- 2. To assign subjects by chance
- 3. Reviews and approves research to ensure participant safety and ethical conduct
- 5. Blinding helps prevents this in clinical trials
- 7. Study phase that focuses on safety, tolerability, and dose-finding in a small group of healthy participants
- 8. Outlines how statistical analysis will be performed
- 11. Group that oversees participant safety and trial integrity