Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits >

Creating a Clinical Trial Subject Record

CRAs can 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.

To create a clinical trial subject record

1. Navigate to the Site Management screen, then the 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
   Early Termination Reason	This field records the reason the subject's participation in the trial was terminated early. The following options are provided: 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
   Early Terminated Date	This field records the date on which the subject's participation in the trial was terminated.
   Encounter Date	This field records the date on which the subject was first registered for the trial.
   Enrollment ID	This is the principal ID number for the subject.
   Informed Consent Date	The date on which the subject signed the informed consent form for participation in the clinical trial. Informed consent must be obtained prior to initiation of any clinical screening procedures.
   Last Completed Visit Date	Select this option to use the last completed clinical visit date for rescheduling clinical visits.
   Randomization ID	An ID number for the subject, which can be used in randomized studies where both an enrollment ID and a randomization ID are required.
   Randomized Date	This field records the date on which the subject was randomized into an arm of the trial.
   Screen Failure Date	This field records the date on which the subject failed screening.
   Screen Failure Reason	This field records the reason why the subject failed screening.
   Screening Number	The Screening Number (#) is generated from the Subject ID field and the Encounter Date field. The Screening Number is automatically generated after the Subject ID field and the Encounter Date field are entered, and the record is saved.
   Status	A multi-value field that contains a history of the subject's status. Date. The date the status was changed or updated. Status. The status of the subject, for example, screened, enrolled, or re-screened. Primary. This flag sets the current status, which displays in the Status field of the Subjects view. Comments. Comments about the subject's status. Visit Type. The type of clinical subject visit, such as Screening or Enrollment. The user can override automatic status updates.
   Subject ID	This field contains a unique identifier for the subject.
   Withdrawn Date	This field records the date on which the subject withdrew from the clinical trial.
   Withdrawn Reason	This field records the reason the subject withdrew from the clinical trial.