Subjects tab

Subjects controls functions for logging and updating subject information during a visit.

Note: The prompts on many of the Subjects menu pages are configured during study design. Prompts are typically required fields unless they are informational (example: a message displaying the specific drug units to give to the subject).

Menu page	Tasks performed
Subject Transactions	List all subjects in the current study. On this page, you can start all of the tasks in the Subject transactions roadmap as well as other related tasks for editing and managing subject visits. Provides access to the complete visit schedule.
Screening	Register a subject's basic demographic information in IRT. This information is checked during each visit to verify the identity of the subject.
Screen Failure	Decline to enroll the subject in the study. Typically screen failing is the result of not meeting the requirements of the study (examples: weight restrictions, issues with medical screening).
Randomization	Randomize the subject into a treatment group. IRT manages the actual process of randomization using information provided by the sponsor, so you only need to click a button to randomize.
Scheduled Visit	Log the details of all regularly scheduled visits on the visit schedule.
Early Termination	Discontinue (early terminate) a subject from the study who is randomized (example: the subject no longer meets the requirements of the study or has asked to leave the study).
Subject Completion	Confirm the final visit of the study for this subject.
Out of Window Approval	Request approval for a visit to be rescheduled from the date on the visit schedule.
Drug Replacement	Request new drug units for drugs that are missing or damaged. These drugs must be assigned through IRT.
Flag Subject page	Identify subjects who have been given the wrong medication. The subject can be marked as mis-randomized, off-treatment, or none (removes the flag).
Subject Visit Details page	Correct an error in the subject information that is entered during a visit.
Subject Transfer	Complete the transfer of the subject to a new site.