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Roadmap: Subject visits

This roadmap lists the typical actions you perform to complete a visit schedule with IRT. The visit schedule varies from study to study so be sure to check the schedule in IRT for your study for exact details.

All actions in this roadmap are started from the Subject Transactions page and should follow the guidelines for subject transactions.

For information on unblinding, see Managing unblinding.

Visit #

Action

What happens?

1

Screen the subject

Screening registers the subject for the study in IRT and assigns a unique screening number.

This step must occur before you can do other tasks related to subjects in IRT, because all tasks after the initial screenings require a subject number.

If necessary, correct subject information.

2

Randomize the subject

The subjects are enrolled in the study and randomly assigned to a treatment.

A subject must be randomized before you can give drugs to that person. All drug units are assigned by IRT.

If necessary, correct subject information.

3
and later

Complete the visit schedule for the subject

The Subject Transactions page shows you the complete visit schedule and guides you through each visit. For example, you must:

  • Accurately identify the subject.
  • Retrieve the specific drug units assigned by IRT from inventory and give those drugs to the subject.
  • Verify that you have given the assigned drug units to the subject.

    If necessary, correct subject information.

Last visit

Register the subject as completed

On the last visit in the visit schedule, you must register the subject as completed; that is, the subject has attended all visits required by the study.

If necessary, correct subject information.

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