Creating Records for Clinical Subjects

CRAs (clinical research associates) can enter information about clinical subjects. When they create the subject record, the subject visit template that is active for the site is used to set up a schedule of visits and activities for the subject.

To create a record for a clinical subject  

1. Navigate to the Site Management screen, then the Protocol Site List view.

2. In the Protocol Site list, drill down on the site number field of the site to which you want to add a subject.

3. Navigate to the Subjects view.

4. In the Subjects list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Last Completed Visit Date	Select this field to use the last completed clinical visit date for rescheduling clinical visits.
   Subject ID	Type a unique identifier for the subject.
   Encounter Date	Select the date that the subject first registers for the trial.
   Screening #	Displays the screening number for the subject. This field is automatically generated from the Subject ID field and the Encounter Date field. The screening number is automatically generated after you enter the Subject ID field and the Encounter Date field, and save the record.
   Enrollment ID	Type the principal ID number for the subject.
   Status	Select a record containing a history of the subject's status. This record contains values for the following fields: Primary. A flag that sets the current status. This status appears in the Status field of the Subjects view. Visit Type. The type of clinical subject visit, such as Screening or Enrollment. Status. The status of the subject, for example, Screened, Enrolled, or Re-screened. Date. The date that users change or update the status. Comments. Comments about the subject's status. You can override automatic status updates.
   Randomization ID	Type an ID number for the subject, which you can use in randomized studies where both an enrollment ID and a randomization ID are required.
   Informed Consent Dates	Select the date that the subject signs the informed consent form for participation in the clinical trial. You must obtain informed consent prior to initiation of any clinical screening procedures.
   Screen Failure Reason	Select the reason the subject fails screening.
   Withdrawn Reason	Select the reason the subject withdraws from the clinical trial.
   Early Termination Reason	Select the reason the subject's participation in the trial terminates early. The following values are available: Adverse Event Completed Death Lack of Efficacy Lost to Follow-Up Non-Compliance with Study Drug Other Physician Decision Pregnancy Progressive Disease Protocol Violation Recovery Screen Failure Study Terminated by Sponsor Technical Problems Withdrawal by Subject Not Done

   
   

Scheduling Clinical Subjects

Scheduling a subject applies the activated subject visit template. You enter a single start date for all subject visit types in the Schedule Date field.

To schedule a clinical subject  

1. Navigate to the Site Management screen, then the Protocol Site List view.

2. In the Protocol Site list, drill down on the site number field of the site for which you want to schedule a subject.

3. Navigate to the Subjects view.

4. In the Subjects list, drill down on the screening number field of the subject to schedule.

   The Visits view of the Subjects screen appears.

   Some fields are described in the following table.

   Field	Comments
   Early Terminated Date	Displays the date that the subject's participation in the trial terminates.
   Randomized Date	Displays the date that you randomize the subject into an arm of the trial.
   Withdrawn Date	Displays the date that the subject withdraws from the clinical trial.
   Screen Failure Date	Displays the date that the subject fails screening.

   
   

5. Click Schedule.

   The Schedule applet is launched.

6. Select a date in the Schedule Date field, and click OK.

   The subject visits record updates as follows:

   • All the visits in the active subject visit template are copied to the Visit Plans list.

   • The Visit Type, Name, Start Date, Planned, Status Tracking Visit, and Status fields are copied from the subject visit template.

   • The planned dates and due dates are calculated using the lead time in the subject visit template and the start date in the Schedule Date field. The planned dates and due dates are calculated as follows:

     planned or due date equals schedule date plus lead time.

Note: You can also schedule subjects through workflows. Set the Enroll Screen Rescreen Through WorkFlow user property to true to execute the schedule subject tasks in workflows instead of executing these tasks through applets and business component methods. If the Enroll Screen Rescreen Through WorkFlow user property is set to true, then workflows in other user properties are executed according to context. You can change workflow names to execute custom workflows. You can also modify other workflows and business service methods according to your needs. For more information about the Enroll Screen Rescreen Through WorkFlow user property, see "User Properties for Business Components in Siebel Clinical".