Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial >

Creating a Subject and Setting Up Visits and Visit Activities (End User)

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

Screening a Subject

It is possible to enter and screen subjects for clinical trials using the Subjects view tab.

To enter and screen a subject

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, drill down on the site for which you want to add subjects.
3. Click the Subjects view tab.
4. In the Subjects list, create a new record and complete the necessary fields.

   Some fields 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 4.
   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.
   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. Date. The date the status was changed or updated. Comments. Comments about the subject's status.

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

   The Visits view of the Subjects screen appears.

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

      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 Applying Protocol Amendments (End User).

7. (Optional) Edit subject visits dates.

   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.

8. (Optional) Create or modify subject visits or activities.

Rescreening 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).

To rescreen a subject

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

   The rescreen visits and activities are automatically created in the subject's schedule.

4. (Optional) Edit subject visits dates.
5. (Optional) Create or modify subject visits or activities.
6. (Optional) Rescreen multiple times.

   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.

Enrolling a Subject

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

To enroll a subject

1. Navigate to the Subjects screen.
2. Drill down on the Screening # for the subject.
3. Click the Visits view tab.
4. 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.

      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.

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

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

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

7. (Optional) Edit subject visit dates.

   See Step 7 for more information about editing visit dates.

8. (Optional) Create or modify subject visits or activities.

Creating an Unscheduled Subject Visit

On occasion, it may be necessary to create an unscheduled subject visit. This can be done in the Subjects screen, or in the Site Calendar.

To create a subject visit from the Subjects screen

1. Navigate to the Subjects screen > Subject List view.
2. In the Subjects list, drill down on the screening number of the subject for whom you want to add an unscheduled visit.
3. Click the Visits View tab.
4. In the Visits list, create a new record and complete the necessary fields. The type of the visit is automatically populated as an Unscheduled Visit.

To create a subject visit from the Site Calendar

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, drill down on the site for which you want to add subject visits.
3. Click the Calendar view tab.
4. Click New Subject Visit to create a new record and complete the necessary fields.

   The Calendar details view is displayed.

   Some fields are described in the following table.

   Field	Comments
   Assigned To	Person to whom the subject visit is assigned.
   Completed	Indicates whether or not the visit has taken place.
   Completed Date	Indicates the date on which the visit took place.
   Due	Date on which the subject visit is due.
   Lock Assignment	Determine whether the Lock Assignment field should be selected. If the activity is locked, Assignment Manager will not access it. If it is unlocked, Assignment Manager can reassign it.

Terminating a Subject's Trial Early

On occasion, it may be necessary to terminate a subject's participation in a trial before completion of the trial. This may be because the subject no longer wished to take part in the trial or because the subject failed a screening.

To terminate a subject's trial early

1. Navigate to the Subjects screen > Subject List view.
2. In the Subjects list, Drill down on the Screening # of the subject whose trial you wish to terminate.
3. Click the select button in the MVG Status field.
4. In the Subject Status dialog box, click the Status field and do one of the following:

   To	Select
   Indicate that the trial was terminated early	Early Terminated
   Indicate that the subject failed the screening	Screen Failure

When either of these two events occur, all remaining visits for the subject are deleted.