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Screening a new subject

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

Best practices for using IRT

  • Enter the subject's screening information as soon as possible to obtain a screening number. This number is required before you can perform additional visits with this subject in IRT. Also, if you don't screen on time, the site might not have enough drug available for the randomization visit.
  • The demographic information you enter in IRT during the screening visit is used to verify the subject's identity in each visit. Make sure this identifying information is accurate and complete.
  • As you enter the screening information, verify it with the subject and the source record.

  1. Click Subjects (Subjects tab (main menu)).
  2. On the left, click Subject Transactions.
  3. Above the list of subjects, click Screening.

    To screen the subject, you respond to the list of prompts on the left. For details on this page, see Screening page.

  4. Select Date of Birth, and then click Continue.

    The format of this date is set during study design, but a hint to the format appears to the right of the Date of Birth drop-down list. If you select the complete date from the calendar, IRT changes the date to the required format.

    If configured for your study, a partial entry, or an entry of Unknown for the day or month of a patient date of birth is accepted.

  5. Select the subject's details for this prompt, and then click Continue.

    Be sure to double-check the information you select at each prompt before clicking Continue to save the information.

  6. Repeat the previous step as many times as necessary to fill in the required information.

    If the subject does not meet the age requirements of the study, you might be asked if you want to continue to screen the subject. If you continue, IRT sends a request for out-of-age approval.

    At the System Assignments prompt, a message tells you the screening number that has been assigned. You might find it useful to make a note of the screening number on the subject's source record.

  7. Click Continue.

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

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