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 shown 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   Withdrawn Reason	Select the reason the subject withdraws from the clinical trial.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