1. Clinical Trial Management System Guide
  2. User Properties for Business Components in Siebel Clinical

User Properties for Business Components in Siebel Clinical

The following table describes the business component user properties that you can use to enable and configure functionality for Siebel Clinical.

User Property

Business Component

Description

Apply Templates WorkFlow Process Name

LS Subject Schedule Date VBC

This property defines the workflow process that is invoked when the Enroll Screen Rescreen Through WorkFlow property is set to Y, and when the Disable Delete Non App Visit property is set to N.

The default value is LS Clinical - ApplyTemplates Process.

If the user clicks No on the pop-up message that the Disable Delete Non App Visit property enables, then LS Clinical - ApplyTemplates Process is invoked, and the subject visit template is applied.

Automatic Missed Status Tracking

Visit Plan

This property configures whether or not Missed status is automatically tracked in the Subject Status MVG (multi value group) for status tracking visits. You configure the status tracking visit for each visit type in the subject visit template.

Configure this property as follows:

  • To enable automatic tracking of Missed status for status tracking visits, set the value to Y.

  • To disable automatic tracking of Missed status for status tracking visits, set the value to N.

The default value is Y.
BIP Report Template Name Clinical Trip Report

This property holds the name for BIP template which will be used to automatically generate BIP report file for integration.

The prerequisite is to set the System-Preference 'CL - Generate TripReport' to Y which will enable Trip Report file generation after approval.

Configure the value as follows:

Syntax: <Visit Type>, <BIP Report Template Name>, <Visit Type>, <BIP Report Template Name>

Example: 

Site Initiation, Template Name 1, Site Monitoring, Template Name 2, Site Close-Out, Template Name 3
  • Name points to type of trip report. Value points to the template name, separated by comma.
  • It's extendable.
  • If report type is not in the Name value list, then the default 'Clinical Trip Report' template will be selected.

The default value is 'Clinical Trip Report'.

Completed Status Code

Visit Plan

This property configures automatic status tracking.

The default value follows is Completed.

Note: Do not change this value.

Date RollUp Fields:Protocol n

Clinical Protocol Site

This property configures automatic rollup of the Last Subject Off Study date from the site record to the protocol record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
 Name>", "<Sort Order>"

The value is set as follows:

"Last Subject Off Study Date", "Last Subject 
Off StudyDate", "(DESCENDING)"
Note: Do not change this value.

Date RollUp Fields:Region n

Clinical Protocol Site

This property configures automatic rollup of the Last Subject Off Study date from the site record to the region record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Sort Order>"

The value is set as follows:

"Last Subject Off Study Date", "Last Subject
Off Study Date", "(DESCENDING)"
Note: Do not change this value.

Delete NonApp WorkFlow Process Name

LS Subject Schedule Date VBC

This property defines the workflow process that is invoked when the Enroll Screen Rescreen Through WorkFlow property is set to Y, and when the Disable Delete Non App Visit property is set to N.

The default value is LS Clinical - DeleteNonAppVisits Process.

If the user clicks OK on the pop-up message that the Disable Delete Non App Visit property enables, then LS Clinical - DeleteNonAppVisits Process is invoked to delete incomplete clinical visits in the previous version of a subject visit template.

Disable Delete Non App Visit

Clinical Subject

This property turns on or off deletion of non applicable clinical subject visits. When users schedule clinical subject visits using a revised subject visit template, a pop-up message appears to confirm if incomplete visits in the previous template version must be deleted, and if complete visits in the new template version must be deleted. Clicking OK in the pop-up message deletes the non applicable subject visits. Clicking Cancel retains the non applicable subject visits.

Configure the value as follows:

  • To enable deletion of non applicable subject visits, set the value to N.

  • To disable deletion of non applicable subject visits, set the value to Y.

The default value is N.
Enable FollowUp Activities for Approved TR Clinical Trip Report

This property enables or disables follow up items, for editing, in an Approved Trip Report.

Configure the value as follows:

  • To enable this property, set the value to Y. It will enable the follow up items, for editing, in an approved trip report.
  • To disable this property, set the value to N. It will disable all follow up items, for editing, in an approved trip report.

The default value is Y.
Enable FollowUp Activities with Status Not Equal To Clinical Trip Report

This property has to be used along with other user property 'Enable FollowUp Activities for Approved TR set as Y.

Valid values for this property are the Status Values of Follow Up items. For example: Done,Completed

It excludes the follow up items with given status to enable on Approved Trip Report.

Configure the value as follows:

  • To enable this property, set the value as follows: (Any values from Follow up items Status, comma separated). It will not enable the Follow up Items in status 'Done' or status 'Completed' for an Approved Trip Report, for editing.
    Done,Completed
  • To disable this property, set the value as Null. This will enable all Follow up items for Approved Trip Report for editing.

The default value is Done.
Enable Question Number Clinical Trip Report

This property enables or disables Question Number on SmartScript Player.

Configure the value as follows:

  • To enable this property, set the value to Y.
  • To disable this property, set the value to N.

The default value is N.
Enable SmartScript Page Save Clinical Trip Report

This property enables or disables auto save of questions from each page while user is on SmartScript player. It saves answers while user is on the smart script player itself on click of Next/Previous buttons.

Configure the value as follows:

  • To enable this property, set the value to Y.
  • To disable this property, set the value to N.

The default value is N.
Enable Unblinding Clinical Trip Report

This property enables or disables Blinded Unblinded functionality.

Configure the value as follows:

  • To enable this property, set the value to Y.
  • To disable this property, set the value to N.

The default value is Y.

Enroll Screen Rescreen Through WorkFlow

LS Subject Schedule Date VBC

This property specifies whether subject visit scheduling tasks are executed through workflows or business component methods.

Configure the value as follows:

  • To execute subject visit scheduling tasks through workflows, set the value to Y.

  • To execute subject visit scheduling tasks through business component methods, set the value to N.

The default value is N.

You configure the workflows that execute the scheduling tasks in the following business component properties:

  • WorkFlow Process Name

  • Apply Templates WorkFlow Process Name

  • Delete NonApp WorkFlow Process Name

Last Subject Off Study Date Rollup Status n

Clinical Protocol Site

This property identifies the qualified subject statuses that are used to populate the date in the Last Subject Off Study field. By default the following statuses are set:

  • Completed

  • Early Terminated

LS Amount Rollup Field 1

Clinical Payments

This property configures automatic rollup of Amount Paid To Date from the payment record to the site record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"Amount Paid To Date", "Amount Paid To Date",
"Rollup Parent Buscomp Name"
Note: Do not change this value.

LS Amount Rollup Field 2

Clinical Payments

This property configures automatic rollup of Amount Earned To Date from the payment record to the site record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"Amount Earned To Date", "Amount Earned To
Date", "Rollup Parent Buscomp Name"
Note: Do not change this value.

LS Amount Rollup Field 3

Clinical Payments

This property configures automatic rollup of VAT amounts from the payment record to the site record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"VAT Amount", "VAT Amount", "Rollup Parent
Buscomp Name"
Note: Do not change this value.

LS Amount Rollup Field 3

Clinical Protocol Site

This property configures automatic rollup of VAT amounts from the site record to the region record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"VAT Amount", "VAT Amount", "Rollup Parent 
Buscomp Name"
Note: Do not change this value.

LS Amount Rollup Field 3

Clinical Region

This property configures automatic rollup of VAT amounts from the region record to the clinical protocol record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"VAT Amount", "VAT Amount", "Rollup Parent 
Buscomp Name"
Note: Do not change this value.

LS Amount Rollup Field 3

Clinical Protocol

This property configures automatic rollup of VAT amounts from the protocol record to the program record.

The value takes the following parameters:

"<Source BC Field Name>", "<Target BC Field
Name>", "<Rollup Parent Buscomp Name>"

The value is set as follows:

"VAT Amount", "VAT Amount", "Rollup Parent 
Buscomp Name"
Note: Do not change this value.

LS Amount Rollup On Status 1

Clinical Payments

This property defines the payment status values that are used to calculate the Paid to Date amount.

By default, only payments with a status of Paid are used to calculate the Paid to Date amount.

This property takes a comma delimited list of values as follows:

"Amount Paid to Date","Paid"

LS Clinical Enable Revert On Status

Clinical Payments

This property defines the payment status values for which the Revert button is enabled.

The value takes a comma delimited list of payment statuses as follows:

"<Status1>", "<Status2>"

By default, the Revert button is enabled for the following payment Status values:

  • In Progress

  • To Be Processed

LS Subject Terminate Study Status Value 1

Clinical Subject Status

This property turns on or off the deletion of incomplete future visits for a subject. These incomplete visits are visits for which the date associated with the subject status has a value, the Completed field for the visit is not selected, and the date in the Date field of the visit is later than the date associated with the subject status. When enabled, the incomplete future visits are deleted if the status of the subject is a value in this property.

By default, this property includes the following values:

  • Screen Failure

  • Early Terminated

Missed Status Code

Visit Plan

This property configures automatic status tracking.

The value is set to Missed.

Note: Do not change this value.

Named Method 1

Action (No Owner Lock)

This property generates payment records.

The value string is set as follows:

"GenerateNewPayment", "INVOKESVC", "Action(No
Owner Lock)", "LS SubjectVisits Service", 
"GeneratePayment", "'Site Id'", "[Protocol 
Site Id]", "'srcBusComp'", "'Action (No Owner
Lock)'", "'srcBusObj'", "'Clinical Protocol
Site'", "'tgtBusObj'", "'Clinical Payments'",
"'tgtBusComp'", "'Clinical Payments'"
Note: Do not change this value.

Named Method 1

LS Clinical Subject Status Snapshot

This property generates the subject status snapshot for a clinical site.

The value string is set as follows:

"SiteSnap", "INVOKESVC", "LS Clinical Subject
Status Snapshot", "LS Clinical Trip Report 
Svc", "GetSiteSnapshot", '"SVId"', 
"ParentFieldValue('Id')"
Note: Do not change this value.

Named Method 2

Clinical Trip Report

This property turns on or off approver verification for trip reports. When enabled, the User Verification screen is launched during the approval process for trip reports to verify the user logon credentials of the approver.

Configure the value as follows:

  • To enable this property, set the value as follows:

    "ValidateUser", "INVOKESVCSEL", "Clinical
Trip Report", "Workflow Process Manager",
"RunProcess", "ProcessName", "LS Clinical 
Trip Report Approval", "RowId", "[Id]", 
"Enable Verification", "Y"

  • To disable this property, set the value as follows:

    "ValidateUser", "INVOKESVCSEL", "Clinical
Trip Report", "Workflow Process Manager",
"RunProcess", "ProcessName", "LS Clinical
Trip Report Approval", "RowId", "[Id]", 
"Enable Verification", "N"

This property is disabled by default, and cannot be null.

Note: Customers who do not have a license for Siebel Tools can use the CL – Verify TripReportApprover system preference to configure this functionality. For more information about configuring system preferences, see System Preferences in Siebel Clinical.

Named Method n

Clinical Protocol Site for Popup

This property associates accounts, activities, and documents for clinical protocols and clinical regions with sites. It specifies the method (for example, ProtocolAccountRolldownToSite) for the appropriate popup applet, the underlying business component (Clinical Protocol Site for Popup) for that applet, the method (ApplyRolldown) in that business component that calls the rolldown business service (LS Clinical Record Rolldown Service), and the appropriate user property (for example, Protocol Account To Site Rolldown) as the input argument for the business service.

To associate accounts for clinical protocols with sites, set the value string as follows:

"ProtocolAccountRolldownToSite", "INVOKESVC",
"Clinical Protocol Site for Popup", "LS 
Clinical Record Rolldown Service",
"ApplyRolldown", "UserPropertyName", 
"Protocol Account To Site Rolldown"

To associate accounts for clinical regions with sites, set the value string as follows:

"RegionAccountRolldownToSite", "INVOKESVC",
"Clinical Protocol Site for Popup", "LS 
Clinical Record Rolldown Service", 
"ApplyRolldown", "UserPropertyName", "Region 
Account To Site Rolldown"

To associate activities for clinical protocols with sites, set the value string as follows:

"ProtocolActivityRolldownToSite", "INVOKESVC",
"Clinical Protocol Site for Popup", "LS
Clinical Record Rolldown Service", 
"ApplyRolldown", "UserPropertyName", 
"Protocol Activity To Site Rolldown"

To associate activities for clinical regions with sites, set the value string as follows:

"RegionActivityRolldownToSite", "INVOKESVC", 
"Clinical Protocol Site for Popup", "LS 
Clinical Record Rolldown Service", 
"ApplyRolldown", "UserPropertyName", "Region
Activity To Site Rolldown"

To associate documents for clinical protocols with sites, set the value string as follows:

"ProtocolDocumentRolldownToSite", "INVOKESVC",
"Clinical Protocol Site for Popup", "LS
Clinical Record Rolldown Service", 
"ApplyRolldown", "UserPropertyName", 
"Protocol Document To Site Rolldown"

To associate documents for clinical regions with sites, set the value string as follows:

"RegionDocumentRolldownToSite", "INVOKESVC",
"Clinical Protocol Site for Popup", "LS
Clinical Record Rolldown Service", 
"ApplyRolldown", "UserPropertyName", "Region 
Document To Site Rolldown"

Status Field RollUp n

Clinical Subject Status

This property collates subject numbers for each status value. You can also configure it to collate subjects status and visit type value pairs. The subject accruals data is rolled up to the site record.

The following comma-delimited parameter configurations are supported:

  • "[Subject Status]", "[Business Component Field Name]", "[Visit Type]"

  • "[Subject Status]", "[Business Component Field Name]", "[Null]"

  • "[Subject Status]", "[Business Component Field Name]"

The Subject Status and Business Component Field Name parameters are mandatory. The Visit Type parameter is optional. The Visit Type value is not populated by default.

The following example provides the default configuration for the Enrolled status, and collates the subjects with an Enrolled status for automatic rollup to the site record:

"Enrolled", "# Enrolled"

Status RollUp Fields:Protocol n

Clinical Protocol Site

This property collates subject numbers for each status value. You can also configure it to collate subjects status and visit type value pairs. The subject accruals data is rolled up to the protocol record.

The following comma-delimited parameter configurations are supported:

  • "[Subject Status]", "[Business Component Field Name]", "[Visit Type]"

  • "[Subject Status]", "[Business Component Field Name]", "[Null]"

  • "[Subject Status]", "[Business Component Field Name]"

The Subject Status and Business Component Field Name parameters are mandatory. The Visit Type parameter is optional. The Visit Type value is not populated by default.

The following example provides the default configuration for the Enrolled status, and collates the subjects with an Enrolled status for automatic rollup to the protocol record:

"Enrolled", "# Enrolled"

Status RollUp Fields:Region n

Clinical Protocol Site

This property collates subject numbers for each status value. You can also configure it to collate subject status and visit type value pairs. The subject accruals data is rolled up to the region record.

The following comma-delimited parameter configurations are supported:

  • "[Subject Status]", "[Business Component Field Name]"

  • "[Subject Status]", "[Business Component Field Name]", "[Visit Type]"

  • "[Subject Status]", "[Business Component Field Name]", "[Null]"

The Subject Status and Business Component Field Name parameters are mandatory. The Visit Type parameter is optional. The Visit Type value is not populated by default.

The following example provides the default configuration for the Enrolled status, and collates the subjects with an Enrolled status for automatic rollup to the region record:

"Enrolled", "# Enrolled"

Status Tracking Field n

Clinical Subject

This property configures automatic status tracking for subject status. By, default, automatic subject status tracking applies to fields related to the following subject statuses:

  • Screen Failure

  • Randomized

  • Withdrawn

  • Early Terminated

You can track additional custom subject statuses by configuring additional values for this property type. This property takes the following comma-delimited list of parameters:

"[Business Component Field Name]", "[DateField]", "[Status Value"

  • [Business Component Field Name] is the name of the business component field that is tracked for automatic status tracking, for example, Randomization ID.

  • [Date Field] is the name of the corresponding date field that is tracked for automatic status tracking, for example, Randomized Date.

  • [Status Value] is the corresponding status value that is tracked for automatic status tracking, for example, Randomized.

Status Tracking Field 1

Clinical Subject

This property configures automatic status tracking for the subject status of Randomized.

The default value follows:

"Randomization Id", "Randomized Date",
"Randomized"

To track additional custom subject statuses, see Status Tracking Field n.

Status Tracking Field 2

Clinical Subject

This property configures automatic status tracking for the subject status of Screen Failure.

The default value follows:

"Reason Excluded", "Screen Failure Date", "Screen Failure"

To track additional custom subject statuses, see Status Tracking Field n.

Status Tracking Field 3

Clinical Subject

This property configures automatic status tracking for the subject status of Withdrawn.

The default value follows:

"Withdrawn Reason", "Withdrawn Date", "Withdrawn"

To track additional custom subject statuses, see Status Tracking Field n.

Status Tracking Field 4

Clinical Subject

This property configures automatic status tracking for the subject status of Early Terminated.

The default value follows:

"Early Termination Reason", "Early Terminated Date",
"Early Terminated"

To track additional custom subject statuses, see Status Tracking Field n.

Trip Report Template Filter 1

Clinical Trip Report

This property filters the trip report templates in the dialog box that appears when users click the select button in the Template field of a Trip Report form. It designates that templates with a protocol that is the same as the protocol for the site visit appear in the dialog box. Templates with no protocol also appear in the dialog box.

The default value follows:

"Protocol Id", "Protocol Id"

The first value designates the field name for protocols in the Clinical Trip Report business component. The second value designates the field name for protocols in the LS Clinical Trip Report Template business component.

Trip Report Template Filter 2

Clinical Trip Report

This property filters the trip report templates in the dialog box that appears when users click the select button in the Template field of a Trip Report form. It designates that templates with a region that is the same as the region for the site visit appear in the dialog box. Templates with no region also appear in the dialog box.

The default value follows:

"Region Id", "Region Id"

The first value designates the field name for regions in the Clinical Trip Report business component. The second value designates the field name for regions in the LS Clinical Trip Report Template business component.

Trip Report Template Filter 3

Clinical Trip Report

This property filters the trip report templates in the dialog box that appears when users click the select button in the Template field of a Trip Report form. It designates that templates with a visit type that is the same as the visit type for the site visit appear in the dialog box. Templates with no visit type also appear in the dialog box.

The default value follows:

"Type", "Visit Type"

The first value designates the field name for visit types in the Clinical Trip Report business component. The second value designates the field name for visit types in the LS Clinical Trip Report Template business component.

Validate Field

LS Subject Enrollment Date VBC
Note: This property is deprecated in version 8.1.1.9 and later.

This property represents the name of the field to validate.

The default value is Enrollment ID.

Validate On 1

Clinical Trip Report

This property turns on or off validation for trip reports that have a status of Rejected.

When enabled, trip reports that have a status of Rejected are validated to ensure that one of the following fields is populated:

  • Reviewer Comments

  • Approver Comments

Configure the value as follows:

  • To enable this property, set the value as follows:

    "Rejected", "Y"

  • To disable this property, set the value as follows:

    "Rejected", "N"

This property is enabled by default.

Validate On 2

Clinical Trip Report

This property turns on or off validation for trip reports that have a status of Submitted.

When enabled, trip reports that have a status of Submitted are validated to ensure that a reviewer is assigned to the trip report.

Configure the value as follows:

  • To enable this property, set the value as follows:

    "Submitted", "Y"

  • To disable this property, set the value as follows:

    "Submitted", "N"

This property is enabled by default.

Validate On 3

Clinical Trip Report

This property turns on or off validation for trip reports that have a status of Submitted for Approval.

When enabled, trip reports that have a status of Submitted for Approval are validated to ensure that an approver is assigned to the trip report.

Configure the value as follows:

  • To enable this property, set the value as follows:

    "Submitted for Approval", "Y"

  • To disable this property, set the value as follows:

    "Submitted for Approval", "N"

This property is enabled by default.

WorkFlow Process Name

LS Subject Schedule Date VBC

This property defines the workflow process that is invoked when the Enroll Screen Rescreen Through WorkFlow property is set to Y.

The default value is LS Clinical - SubjectVisits Process.

This workflow process applies the approved subject visit template to the subject.

If the subject visit template that is applied is different from the previous version of the subject visit template that was applied, and if the Disable Delete Non App Visit property is set to N, then a pop-up message appears to confirm if incomplete visits in the previous template version must be deleted, and if complete visits in the new template version must be deleted. Clicking OK in the pop-up message deletes the non applicable subject visits. Clicking Cancel retains the non applicable subject visits.