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Replacing missing or damaged supplies for a subject

IRT assigns drugs to a subject that are missing or damaged, you must request new drug units through IRT. For more information, see Problems with drug supplies.

Best practices for using IRT

If you are replacing damaged drugs from a previous visit, check the drugs provided in the previous visit so you know which drug units the subject received.

  1. Click Subjects (Subjects tab (main menu)).
  2. On the left, click Subject Transactions.
  3. Find the subject in the list.
  4. 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.
  5. Above the visit schedule, click Drug Replacement.
  6. Confirm the demographic details of the subject by selecting Yes from the drop-down list, and click Continue.
  7. From the drop-down list, select the number of the drug unit that is being replaced, and then click Continue.
  8. Fill in the details for the prompt, and then click Continue to view the next prompt.

    The prompts you see depend on the type of drug unit and the design of the study. However, you must confirm the drug unit number and lot number when asked for this information.

    You can replace only one drug unit at a time. You can replace additional drug units for a subject only after you enter the required information for the current drug unit.

  9. Repeat the previous step as many times as necessary to fill in the required information.
  10. Select the Drug Replacement Date, and click Continue.

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

  11. Retrieve these exact drug units from the depot, and give them to the subject. Do not substitute other drug units.
  12. Click Continue.

    The last prompt informs you that the new drug units are assigned, and IRT sends the confirmation email.

  13. Print the email, and file the printed copy according to the policies of the study.
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