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Randomizing a subject

During randomization, IRT identifies the exact drug units to give to the subject. For more information, see The randomization visit.

You must screen the subject in IRT before that subject can be randomized.

Best practices for using IRT
  • Always verify the subject's identifying information against the source record during the visit. Be absolutely certain you are providing the correct drug to the correct subject.
  • Do not pull drug units for the subject from inventory until the units have been assigned by IRT during a visit. You must provide the specific units assigned by IRT to the subject.
  1. Click Subjects (Subjects tab (main menu)).
  2. On the left, click Subject Transactions.
  3. Find the subject in the list.

    Click More detail icon - click to expand the form to the left of the subject number, or select the row with the subject you want to view.

  4. Find the randomization visit in the visit schedule, and click Randomization.
  5. Confirm the subject demographics with the subject and source record to make sure you are meeting with the correct person.
  6. If the demographic information is correct, select Yes from the drop-down list, and then click Continue.

    or

    If the information is not correct, select No. If possible, update the subject information. Contact your field monitor for instructions.

  7. Select the randomization date, and click Continue to view the information you must provide for the next prompt.

    If a message tells you the visit is out of window, see Logging an out-of-window visit.

  8. If additional prompts appear, fill in the details for each prompt, and then click Continue.
  9. Repeat the previous step as many times as necessary to fill in the required information.

    At the System Assignments prompt, a message lists the specific drug units IRT has assigned specific drug units to the subject. The unit numbers, lots, and expiration date are listed.

  10. Retrieve these exact drug units from the site inventory, and give them to the subject. Do not substitute other drug units.

    If you cannot find these units or they are damaged, you must log a request to replace missing or damaged supplies.

  11. Click Continue.

    The last prompt informs you that the subject has been randomized, and IRT sends the confirmation email.

  12. Print the email, and file the printed copy according to the policies of the study.
  13. (optional) Select Back to the Subject to check the date of the next visit.
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