Previous Topic

Next Topic

Book Contents

Screen failing a subject

After a subject has been screened in IRT, you can screen fail a subject who has been identified as not meeting the requirements of the study. For more information, see Screen failures (after screening).

Best practices for using IRT

  • Log the subject information for all visits into IRT to keep an accurate count of the number of subjects for the study. These results have a direct impact on the success of the study.
  • Screen failing and early termination affect the drug supply, so make sure you perform these tasks in IRT right away.
  • Make sure the information you log during a visit is correct.

  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. Above the visit schedule, click Screen Fail.
  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. If you are asked to provide the reason for the screen failure, select the reason from the drop-down list, and then click Continue.
  8. Type or select the date the screen failure was reported, and click Continue.

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

  9. Print the email, and file the printed copy according to the policies of the study.
Send Feedback