Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2016 E52416-01 |
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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
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site to which you want to add a subject.
Navigate to the Subjects view.
In the Subjects list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field | Comments |
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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:
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Withdrawn Reason | Select the reason the subject withdraws from the clinical trial.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:
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