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).
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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. |
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Register a subject's basic demographic information in IRT. This information is checked during each visit to verify the identity of the subject. |
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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). |
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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. |
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Log the details of all regularly scheduled visits on the visit schedule. |
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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). |
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Confirm the final visit of the study for this subject. |
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Request approval for a visit to be rescheduled from the date on the visit schedule. |
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Request new drug units for drugs that are missing or damaged. These drugs must be assigned through IRT. |
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Identify subjects who have been given the wrong medication. The subject can be marked as mis-randomized, off-treatment, or none (removes the flag). |
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Correct an error in the subject information that is entered during a visit. |
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Complete the transfer of the subject to a new site. |