In a basic Clarity Clinical Trial data model, which entity represents enrollment and includes a surrogate primary key, foreign keys to trial and patient, plus enrollment_date and arm?

In a basic Clarity Clinical Trial data model, which entity represents enrollment and includes a surrogate primary key, foreign keys to trial and patient, plus enrollment_date and arm?

• A. TRIAL
• B. PATIENT
• C. ENROLLMENT
• D. SITE Gryphon

Answer: (C)

Enrollment captures a patient's participation in a specific trial as a distinct record. It uses a surrogate primary key (for example, enrollment_id) and includes foreign keys that link to the trial and to the patient, tying together who is in which study. It also holds the enrollment_date, which tracks when the patient joined the study, and arm, which indicates which treatment group they were assigned to within that trial. This pairing of a unique enrollment identifier with the two foreign keys and these attributes is exactly what you need to record a participant’s enrollment event, separate from the general trial data or the patient’s basic details. A site can be modeled separately if needed, but the enrollment record itself is the proper place to represent the enrollment instance.

Enrollment captures a patient's participation in a specific trial as a distinct record. It uses a surrogate primary key (for example, enrollment_id) and includes foreign keys that link to the trial and to the patient, tying together who is in which study. It also holds the enrollment_date, which tracks when the patient joined the study, and arm, which indicates which treatment group they were assigned to within that trial. This pairing of a unique enrollment identifier with the two foreign keys and these attributes is exactly what you need to record a participant’s enrollment event, separate from the general trial data or the patient’s basic details. A site can be modeled separately if needed, but the enrollment record itself is the proper place to represent the enrollment instance.