Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial > End-User Procedures >

Adding a Subject and Setting Up Visits and Visit Activities

CRAs may enter information about clinical trial subjects. Once the subject record is added, the subject visit template active for the site can be applied to set up a schedule of visits and activities for the subject.

To enter and screen a subject

  1. Navigate to the Site Management screen.
  2. From the Show drop-down list, select My Sites.
  3. In the Sites list, select the site for which you want to add subjects.
  4. Click the Subjects view tab.
  5. In the Subjects list, add a record, and complete the necessary fields.

    6. Some of the fields in a Subjects record are described in the following table.

    Field
    Comments
    Enrollment Id
    This is the principal ID number for the subject. The value is entered when you click the Enroll button (Step 8).
    Informed Consent
    An informed consent date must be entered before a subject can be enrolled in the protocol. See Step 3.
    Randomization Id
    An ID number for the subject, which can be used in studies where both an enrollment ID and a randomization ID are required.
    Screen Failure Reason
    The choices in this drop-down list are configured by using the CLINCL_REASON_EXCLUDED type in the List of Values.
    Screening #
    This field is based on the subject's initials and date of birth. It is automatically populated after Subject Initials and Date of Birth fields are entered and the record is saved.
    Status
    A multi-value field that contains a history the subject's status.
    Primary. This flag sets the current status, which displays in the Status field of the Subjects view.
    Status. The status of the subject, for example, screened, enrolled, or re-screened. The choices in this drop-down list are configured by using the CLNCL_SUBJECT_STATUS type in the List of Values.
    Date. The date the status was changed or updated.
    Comments. Comments about the subject's status.
    Withdrawn Reason
    The choices in this drop-down list are configured by using the CLINICAL_WITHDRAWN_REASON type in the List of Values.

  6. Click the hyperlink in the Screening # field of the subject.

    7. The Visits view of the Subjects screen appears.

  7. To generate screening visits and activities:
    1. Click Screen in the Subject form.
    2. Enter the screen date in the Screening dialog box.

      3. Screening visits and activities to take place in those visits appear in the Visits and Activities lists.

      NOTE:  A subject can be screened only once for each visit template. After screening visits have been generated, clicking the Screen button again and changing the screen date reschedules the screening visits according to the new screen date. (If the subject visit template has been updated since the last time the screen button was clicked, new screening visits are generated.) See Updating a Protocol Version at a Site.

  8. Optional: Edit subject visits dates.

    9. For example, you might want to edit some subject visit dates so that visits are not scheduled on weekends.

    If the rescheduled date falls outside the range specified by the subject visit template, the application displays a warning message, but still reschedules the visit according to the new date.

  9. Optional: Add or modify subject visits or activities.

To rescreen a subject

A subject who initially fails screening can be rescreened. The rescreen date must be greater than or equal to the screen date, and rescreening cannot happen if the subject has not already been screened (that is, if the screen date is null).

  1. Navigate to the Subjects screen, and select the subject who is eligible for the study. (The subject must have already been screened.)
  2. Click Rescreen in the Subject form, and enter a rescreen date.

    3. The rescreen visits and activities are automatically added to the subject's schedule.

  3. Optional: Edit subject visits dates.
  4. Optional: Add or modify subject visits or activities.
  5. Optional: Rescreen multiple times.

    6. A subject can be rescreened more than once. Each time the Rescreen button is clicked and the rescreen date entered, a new set of the rescreening visits and activities is generated and appended to the existing ones. This applies even though the subject visit template has not been changed.

To enroll a subject

A subject who has successfully passed screening or rescreening is then enrolled in the study.

  1. Navigate to the Subjects screen, and select the subject.
  2. Click the Visits view tab.
  3. Enter the informed consent date:
    1. Click the select button in the Informed Consent Dates field to open the Informed Consent dialog box.
    2. Click New.

      3. The versions of the subject visit template appear in the drop-down list of the Add Informed Consent dialog box. Make sure to select the version before entering the informed consent date.

    3. Click Add.
    4. In the Informed Consent Dates dialog box, enter an informed consent date for the subject, and close the Informed Consent Dates dialog box.

      5. NOTE:  Enrollment activities cannot be generated without an informed consent date for the active version of the protocol.

  4. Click the Enroll button in the Subject form.
  5. Enter the enrollment date and the enrollment ID in the Enrollment dialog box.

    6. The enrollment date must be greater than or equal to the screen date.

  6. Optional: Edit subject visit dates.

    7. See Step 8 for more information about editing visit dates.

  7. Optional: Add or modify subject visits or activities.

 Siebel Life Sciences Guide 
 Published: 18 April 2003