The number of patients or experimental units required for a trial.
See Serious Adverse Event.
Risk to individual subject vs. potential benefits. Also called Risk-Benefit Analysis.
Investigator, subinvestigator and clinical research coordinator involved with study.
Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.
In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the entire drug approval process.
Time allowed to enroll all subjects for a study.
Act of enrolling subjects with the proper inclusion criteria.
A method based on chance by which study subjects are assigned to a treatment group. The method minimizes differences among groups by equally distributing people with particular characteristics among all trial arms.