5Administering Clinical Subjects and Clinical Visits

Administering Clinical Subjects and Clinical Visits

This chapter covers administering clinical subjects and clinical visits. It includes the following topics:

• About Subject Visit Templates

• Process of Defining Subject Visit Templates

• Approving Subject Visit Templates

• About Automatic Tracking of Subject Status

• Creating Records for Clinical Subjects

• Scheduling Clinical Subjects

• Rescheduling Clinical Subjects

• Administering Subject Visits in Batch Mode

• Screening Clinical Subjects

• Rescreening Clinical Subjects

• Enrolling Clinical Subjects

• Randomizing Clinical Subjects

• Overriding Initial Subject Status

• Transferring Clinical Subjects

• Viewing Subject Transfer Information for Clinical Subjects and Sites

• Viewing Subject Visits Information for Sites

• Creating Unscheduled Subject Visits

• Terminating Clinical Trials Early for Clinical Subjects

• Applying Protocol Amendments to Sites and Clinical Subjects

• About Rolling Up Information for Subject Enrollment

• Viewing Status Accruals for Clinical Subjects of Sites

• Viewing Status Accruals for Clinical Subjects of Clinical Regions

• Viewing Status Accruals for Clinical Subjects of Clinical Protocols

• Monitoring Rates for Subject Enrollment

• Monitoring Status Accruals for Clinical Subjects by Visit Type

• Using Audit Trail for Changes to Subject Status

• Generating Oracle BI Publisher Reports for Site Enrollment Status

About Subject Visit Templates

Subject visit templates allow you to set up a clinical visit schedule using the clinical protocol. The template is then used to generate screening, rescreening, and enrollment schedules for each subject, according to the subject’s screening, rescreening, and enrollment dates.

If you amend the protocol, then you must create new versions of the subject visit template to reflect the modifications to the protocol.

Process of Defining Subject Visit Templates

To define a subject visit template for scheduling subject visits, perform the following tasks:

• Creating Subject Visit Templates

• Defining Versions for Subject Visit Templates

• Defining Subject Visits

• Defining Planned Subject Visits

• Defining Activities for Subject Visits

Creating Subject Visit Templates

This topic describes how to create a subject visit template.

This task is a step in Process of Defining Subject Visit Templates.

To create a subject visit template

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. In the Subject Visit Templates list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Name	Type the name of the subject visit template.
   Protocol #	Select the protocol for the subject visit template. Select from the list of existing protocols in the Pick Protocol dialog box.
   Title	Displays the title for the protocol that you select.
   Comments	Type comments about the subject visit template.

Defining Versions for Subject Visit Templates

This topic describes how to define a version for a subject visit template.

This task is a step in Process of Defining Subject Visit Templates.

To define a version for a subject visit template

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. In the Template Versions list, create a new template version record or select a version that you created by using the Versions view.

   Some fields are described in the following table.

   Field	Comments
   Version	Select the version of the subject visit template.
   Comments	Type comments about the version. This field has a maximum character length of 250 characters. This field is not copied when you copy the subject visit template.
   Start Date	Select the date that you create the version of the subject visit template.
   End Date	Select the date that you must complete the version of the subject visit template.
   Status	Select the status of the version of the subject visit template. The following values are available: In Progress Approved Obsolete When you create a new version of the subject visit template, the Status field is populated with a value of In Progress.
   Change Summary	Type a summary of changes to the version of the subject visit template.

Defining Subject Visits

This topic describes how to define subject visits in a subject visit template.

This task is a step in Process of Defining Subject Visit Templates.

To define subject visits

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. For the new template version record, create a visit record in the Visits list for each visit that a subject will make to the site.

   Some fields are described in the following table.

   Field	Comments
   Sequence	Type the sequence number of the visit. Typically, the first visit has a sequence number of 1.
   Visit Type	Select the type of clinical visit. The following preconfigured values are available: Screening Rescreening Enrollment End of Study You can add, modify, or delete values for the Visit Type field.
   Name	Type the name of the visit, for example, screening or baseline.
   Planned	Select this field to define a subject visit as a planned visit. This field is selected by default.
   Status Tracking Visit	Select this field to enable automatic tracking of the status in the Subject Status MVG (multi value group) for each visit type. You can set only one visit as the status tracking visit for each visit type. For example, if TreatmentPhase1, TreatmentPhase2, and TreatmentPhase3 clinical visits exist for a Treatment visit type, then you can set only TreatmentPhase3 as the status tracking visit. When you select the Status Tracking Visit field for a visit, the following status records are automatically created in the Subject Status MVG when each predefined visit type is processed: A Visit Type value of Screening creates a Screened status record in the Subject Status MVG. A Visit Type value of Re-Screening creates a Re-screened status record in the Subject Status MVG. A Visit Type value of Enrollment creates an Enrolled status record in the Subject Status MVG. A Visit Type value of End of Study creates a Completed status record in the Subject Status MVG. You can manually override the automatic value in the Subject Status MVG. Any create, update, or delete operations on the tracked status fields trigger automatic create, update, and delete operations in the Subject Status MVG. Automatic status tracking is not enabled for custom values in the Visit Type list. You can edit the Status Tracking Visit field only in the subject visit template. This field is read-only when copied to the subject’s visit plan. If you do not enable automatic status tracking for a clinical visit, then you can manually create, update, and delete status records in the Subject Status MVG. The following conditions apply: You can create only one status record for each visit type. Multiple status records for the same visit type are not permitted. If Visit Type is not null, then it must be unique. When Visit Type is null, the status value must be unique. Multiple status records with the same Status value, and a null Visit Type, are not permitted. The value pair of Visit Type and Status must be unique.
   Lead	Type the lead time from the start date. You define the start date in the Schedule Date field when scheduling the subject.
   Lead Units	Select the units for the lead time.
   Min	Type the time before the lead time that the visit can occur. For example, if Min is 1 and Min/Max Units is days, then the visit can occur one day before the scheduled date. Do not leave this field empty.
   Max	Type the time after the lead time that the visit can occur. For example, if Max is 2 and Min/Max Units is days, then the visit can occur up to two days after the scheduled visit. Do not leave this field empty.
   Min/Max Units	Select the units for the Min and Max values. Do not leave this field empty.
   # CRF Pages	Type the number of CRF (case report form) pages.
   Status	Select the status of the visit. The following subject status values are available: Screened Screen Failure Randomized Enrolled Completed Early Terminated Re-screened Withdrawn The Status field is not copied when you copy the subject visit template to the subject’s visit plan.

Defining Planned Subject Visits

This task describes how to define planned subject visits for the clinical trial. For example, complete this task to define whether treatment visits or surgery visits are planned for a subject.

This task is a step in Process of Defining Subject Visit Templates.

To define planned subject visits

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. In the Visits list, define the planned subject visits using one of the following methods:

   1. To define all the subject visits as planned visits, click Plan All.

   2. To define selected subject visits as planned visits, select the Planned field for each visit.

Defining Activities for Subject Visits

This task describes how to define activities for subject visits in the clinical trial.

This task is a step in Process of Defining Subject Visit Templates.

To define activities for a subject visit

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. For each visit record, create a set of activity records in the Activities list to describe the procedures and tasks required for the visit.

   Some fields are described in the following table.

   Field	Comments
   Duration	Select the estimated length of time to complete the activity.
   Payment Flag	Select this field to indicate that you pay the investigator for this activity. This flag is selected by default. For more information about payments, see Setting Up and Making Clinical Payments
   Payment Amount	Type the standard amount that you pay the investigator for this activity. You can adjust this amount for each site or each individual.

Approving Subject Visit Templates

Setting the status of a subject visit template to approved sets the subject visit template as read-only. You can modify only the Approved Date field of an approved subject visit template.

To approve a clinical subject visit template

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

2. In the Template Versions list, select the version of the template to approve.

3. Enter the date in the Approval Date field.

4. Select Approved in the Status field.

About Automatic Tracking of Subject Status

This topic describes the fields that the mechanism for automatically tracking subject status uses, and the automatic operations that they trigger in the Subject Status MVG (multi value group). The Subject Status MVG contains a history of the subject’s status. It contains the following fields.

• Date. The date that users change or update the status.

• Status. The status of the subject, for example, Screened, Enrolled, or Re-screened.

• Primary. A flag that sets the current status. This field appears in the Status field of the Subjects view.

• Comments. Comments about the subject status.

• Visit Type. The type of clinical subject visit, such as Screening or Enrollment. This field is null for status records, such as Randomized and Withdrawn.

Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG

The following information lists the status tracking fields that trigger create and delete operations on the records in the Subject Status MVG. The records in the Subject Status MVG are automatically updated as follows:

• Populating a status tracking field listed in the following table automatically creates the corresponding status record in the Subject Status MVG, including Status, Date, and Visit Type fields, where applicable

• Deleting a status tracking field listed in the following table automatically deletes the entire corresponding status record in the Subject Status MVG, including the Status, Date, and Visit Type fields, where applicable.

Table Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG

Status Tracking Field	Record in Subject Status MVG Automatically Created or Deleted
Random ID	Randomized
Screen Failure Reason	Screen Failure
Withdrawn Reason	Withdrawn
Early Termination Reason	Early Terminated
Missed	Missed
Completed	Status that the status value in the Visit Plans list for that visit defines
Override Status	Missed, or the status that the status value in the Visit Plans list for that visit defines

Status Tracking Fields that Trigger Update Operations on Fields of Subject Status MVG

The following information lists the status tracking fields that trigger update operations on the Date and Status fields of the Subject Status MVG. The fields of the Subject Status MVG are automatically updated as follows:

• Populating or updating a status tracking field listed in the following table automatically triggers an update to the corresponding Date or Status field value in the Subject Status MVG.

• Deleting a status tracking field listed in the following table automatically triggers a delete operation on the corresponding Date or Status field value in the Subject Status MVG.

Table Status Tracking Fields that Trigger Update Operations on Fields of Subject Status MVG

Status Tracking Field	Field of Subject Status MVG Automatically Updated
Randomized Date	Date field in the record of the Subject Status MVG with a Status field of Randomized
Screen Failure Date	Date field in the record of the Subject Status MVG with a Status field of Screen Failure
Withdrawn Date	Date field in the record of the Subject Status MVG with a Status field of Withdrawn
Early Terminated Date	Date field in the record of the Subject Status MVG with a Status field of Early Terminated
Completed Date	Date field in the record of Subject Status MVG
Override Status	Status field in the Subject Status MVG is updated to Missed, or the status value in the Visit Plans list for that visit.

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: 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.

Rescheduling Clinical Subjects

You can reschedule clinical subject visits using a fixed date, or using the delay between the Planned Date and Completed Date for the last completed visit. Select the Last Completed Visit Date field to base the rescheduling of subject visits on the date of the last completed visit, and deselect this field to base the rescheduling of subject visits on a fixed date. You can define the rescheduling mechanism at the site level. The selected rescheduling option at the subject level overrides the selected option at the site level.

To reschedule 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 reschedule a subject.

3. Navigate to the Subjects view.

4. Drill down on the screening number field of the subject to reschedule.

   The Visits view of the Subjects screen appears.

5. Complete one of the following steps:

   • Deselect the Last Completed Visit Date field to reschedule subject visits using a fixed date.

   • Select the Last Completed Visit Date field to reschedule subject visits using the date of the last completed visit.

6. Click Reschedule.

7. To reschedule subject visits using a fixed date, enter a date in the Reschedule applet.

   The subject visit dates are rescheduled as described in the following table.

   Reschedule Option	Reschedule Mechanism
   Fixed Date	The remaining subject visit dates are rescheduled using the date in the Reschedule applet.
   Last Completed Visit Date	The remaining subject visit dates are rescheduled using the delay between Planed Date and Completed Date for the last completed visit. The rescheduled dates for the planned dates and due sates are calculated as follows: Planned or Due Date equals Planned Date or Due Date plus Delay

Administering Subject Visits in Batch Mode

The Visit Types view displays the subject visit plan by visit type. Each distinct visit type for the subject appears in the Visit Types applet, with a read-only field indicating whether or not each visit type is planned for the subject. Associated visits for each visit type appear for batch administration, and associated activities for each visit also appear. The Visit Types view provides for the following administration tasks:

• Viewing clinical visit types for each subject, the associated visits, and the associated activities.

• Planning and unplanning clinical visits in batch mode, by visit type.

• Deleting clinical visits in batch mode, by visit type.

To administer subject visits in batch mode

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 administer visits.

3. Navigate to the Subjects view.

4. In the Subjects list, drill down on the screening number field of the subject for which you want to administer visits.

5. The Visits view of the Subjects screen appears.

6. Navigate to the Visit Types view.

7. The visit types, associated visit plans, and associated activities appear.

8. Complete one of the following steps:

   • To plan all visits associated with a visit type, select the visit type, and click Plan.

   • To unplan all visits associated with a visit type, select the visit type, and click Unplan.

   • To delete a visit type and all associated visit plans, select the visit type, and click Delete Visits.

Screening Clinical Subjects

You can schedule screening visits when the subject signs the informed consent form. The Subject Status MVG (multi value group) is automatically updated for the screening visit that is the status tracking visit in the subject visit template.

To screen 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 screen a subject.

3. Navigate to the Subjects view.

4. In the Subjects list, enter the informed consent date for the subject to screen as follows:

   • Click the select button in the Informed Consent Dates field to open the Informed Consent Dates dialog box.

   • Select the appropriate version.

   • Enter an informed consent date for the subject, and click OK.

5. In the Subjects list, drill down on the screening number field of the subject.

   The Visits view of the Subjects screen appears.

6. (Optional) Edit subject visit dates or activities.

   For example, you might want to edit some subject visit dates so that visits are not scheduled on weekends. If the rescheduled date is outside the range that the subject visit template specifies, then a warning message appears, but the visit is still rescheduled according to the new date.

7. Select the Completed field for the screening visit in the Visit Plans list.

8. Enter the completion date in the Completed Date field.

   If the subject clinical visit is a status tracking milestone visit, then the subject record automatically updates as follows:

   • A record with a value of Screening in the Visit Type field is added to the Subject Status MVG.

   • The Status field is updated to Screened.

   • The Date field of the Subject Status MVG is populated with the date in the Completed Date field of the Visit Plans list.

Rescreening Clinical Subjects

You can rescreen a subject who initially fails screening. You must define the Re-screening visit type in the visit plan for the subject. The Subject Status MVG (multi value group) is automatically updated for the re-screening visit that is the status tracking visit in the subject visit template.

To rescreen a clinical subject

1. Navigate to the Subjects screen.

2. Drill down on the screening number field of the subject who failed screening.

3. Navigate to the Visits view.

4. (Optional) Edit subject visit dates or activities.

5. Select the Completed field for the Re-screening visit in the Visit Plans list.

6. Enter the completion date in the Completed Date field.

   If the subject clinical visit is a status tracking milestone visit, then the Subject record automatically updates as follows:

   • A record with a value of Re-screening in the Visit Type field is added to the Subject Status MVG.

   • The Status field is updated to Re-screened.

   • The Data field of the Subject Status MVG is populated with the date in the Completed Date field of the Visit Plans list.

Enrolling Clinical Subjects

You enroll in the study a subject who successfully passes screening or rescreening. The Subject Status MVG (multi value group) is automatically updated for the enrollment visit that is the status tracking visit in the subject visit template.

To enroll a clinical subject

1. Navigate to the Subjects screen.

2. Drill down on the screening number field for the subject to enroll.

3. Navigate to the Visits view.

4. (Optional) Edit subject visit dates or activities.

5. Enter the enrollment ID in the Subjects applet.

6. In the Visit Plans list, complete the following steps:

   1. Select the Completed field for the enrollment visit.

   2. Enter the completion date in the Completed Date field.

      If the subject clinical visit is a status tracking milestone visit, then the Subject record automatically updates as follows:

      • A record with a value of Enrollment in the Visit Type field is added to the Subject Status MVG.

      • The Status field is updated to Enrolled.

      • The Date field of the Subject Status MVG is populated with the date in the Completed Date field of the Visit Plans list.

Randomizing Clinical Subjects

This topic describes how to randomize a subject for a randomized clinical trial.

To randomize 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 randomize a subject.

3. Navigate to the Subjects view.

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

   The Visits view of the Subjects screen appears.

5. Complete the required fields.

   Some fields are described in the following table.

   Field	Comments
   Random ID	Type the ID number assigned to the subject for the randomized trial.
   Randomized Date	Select the date that you randomize the subject into an arm of the trial.

6. Save the record.

   The Subject record automatically updates as follows:

   • A Randomized status record is added to the Subject Status MVG (multi value group), and the value in the Randomized Date field is copied to the Date field of the Subject Status MVG.

   • The Status field is updated to Randomized.

Overriding Initial Subject Status

You can override the initial subject status for a status tracking clinical visit by selecting a new status in the Override Status field. For example, for a status tracking clinical visit with a Missed value, you can subsequently set the Override Status field to Completed.

When you select the Completed value from the Override Status field, the previous Missed value is updated to the status value for that visit in the Visit Plans list. For example, the status value for the Screening visit type is updated to Screened.

When you select the Missed value in the Override Status field, the previous status record for that visit is updated to Missed.

To override initial subject status

1. Navigate to the Subjects screen.

2. Drill down on the screening number field for the subject.

3. Navigate to the Visits view.

4. Select one of the following values from the Override Status field:

   • Completed

   • Missed

5. For a completed visit, enter the completion date in the Completed Date field.

Transferring Clinical Subjects

The subject transfer feature allows you to manage the transfer of subjects from one study site to another, with options to retain the subject’s visit data and also the destination study sites’s visit template. During subject transfers, the payment exceptions from the destination site are applied and the payment data is recalculated. A history of all subject transfers is tracked at the subject and the site level. To ensure more robust data audit trails, you can no longer delete subjects and sites.

To transfer clinical subjects

1. Navigate to the Subjects screen, then the Subject List view.

2. In the Subject list, select the subject that you want to transfer.

3. Click Transfer.

   The Transfer applet is launched.

4. In the Transfer applet, complete the fields as shown in the following table.

   Field	Description
   Site	Select the destination site to which you want to transfer the subject. Only sites within the same protocol are included in the Sites drop-down list.
   Informed Consent Date	Select an informed consent date if prompted.
   Scheduled Date	The start date for the destination site’s clinical subject visits.
   Reason	Select a reason for the subject transfer from the Reason drop-down list.
   Comments	Type in any comments about the subject transfer as required.
   Transfer Date	The date of the subject transfer.

5. If the destination sites’s Subject Visit Template version differs from the originating site, then you are prompted with a message similar to the following:

   Would you like to delete uncompleted visits from the old version and completed visits from the new version?

   Click OK to confirm the deletion of non applicable visits.

   After confirmation, the subject transfer process completes, new visits and payment exceptions are applied as defined by the destination site, and the transfer history for the subject and the site is updated accordingly. For more information, see Viewing Subject Transfer Information for Clinical Subjects and Sites.

Viewing Subject Transfer Information for Clinical Subjects and Sites

The Transfer History and Subject Transfer History views show all the subject transfer information for subjects and sites respectively.

To view subject transfer information for clinical subjects and sites

1. View the subject transfer information for a subject as follows:

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

   2. Drill down on the Site # field of the site that you want.

   3. Navigate to the Subjects view.

   4. Drill down on the Screening # field of the subject for which you want to view subject transfer information.

      The Visits view of the Subjects screen appears showing the Visit Plans.

   5. Navigate to the Transfer History view.

      The Transfer History view appears showing all subject transfers against the subject. The view includes the following information for each subject transfer: Source Site Name, Destination Site Name, Transfer Date, Transferred By, Status at Transfer, Description.

2. View the subject transfer information for a site as follows:

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

   2. Drill down on the Site # field of the site for which you want to view subject transfer information.

   3. Navigate to the Subject Transfer History view.

      The Subject Transfer History view appears showing all subject transfers against the site as follows:

      • The Subject In applet lists all subject visits transferred to the site.

      • The Subject Out applet lists all subject visits transferred from the site.

Viewing Subject Visits Information for Sites

The Subjects Visits view shows information about all the completed subject visits for a site, including any completed subject visits where the subject has been transferred to another site.

To view subject visits information for sites

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

2. Drill down on the Site # field of the site for which you want to view subject visits.

3. Navigate to the Subjects Visits view.

   The Subjects Visits view appears showing all completed subject visits (including subject visits where the subject has been transferred to another site) and corresponding activity information for the selected site.

Creating Unscheduled Subject Visits

On occasion, you might have to create an unscheduled subject visit.

Creating a Subject Visit From the Subjects Screen

Complete the procedure in this topic to create a subject visit from the Subjects screen.

To create a subject visit from the Subjects screen

1. Navigate to the Subjects screen, then the Subject List view.

2. In the Subject list, drill down on the screening number field of the subject for whom you want to add an unscheduled visit.

3. Navigate to the Visits view.

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

   The type of the visit is automatically populated with Unscheduled Visit.

Creating a Subject Visit From the Calendars for Sites

Complete the procedure in this topic to create a subject visit from the calendar for a site.

To create a subject visit from the calendar for a site

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 add subject visits.

3. Navigate to the Calendar view.

4. Create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Done	Select the date that the visit occurred.
   Done Flag	Select this field to indicate that the visit occurred.
   Calendar Planned	Select the date and time that the subject visit is due. This field value is automatically populated in the Due field.
   Lock Assignment	Select this field as necessary. If the activity is locked, then Assignment Manager cannot access it. If it is unlocked, then Assignment Manager can reassign it.
   Assigned To	Select the user ID of the person assigned to the subject visit.

Terminating Clinical Trials Early for Clinical Subjects

On occasion, you might have to terminate a subject’s participation in a trial before completion of the trial. For example, the subject might no longer want to take part in the trial, or the subject might fail a screening.

To terminate a clinical trial early for a clinical subject

1. Navigate to the Subjects screen, then the Subject List view.

2. In the Subject list, drill down on the screening number field of the subject of the trial you want to terminate.

3. Enter the reason for terminating the subject’s trial using one of the following methods:

   • To indicate that the subject failed the screening, enter the reason in the Screen Failure Reason field.

   • To indicate that the subject withdrew from the trial, enter the reason in the Withdrawn Reason field.

   • To indicate that the subject’s trial terminated early, select the reason in the Early Termination Reason field.

4. Enter the date for terminating the subject’s trial using one of the following methods:

   • To indicate that the subject failed the screening, enter the date in the Screen Failure Date field.

   • To indicate that the subject withdrew from the trial, enter the date in the Withdrawn Date field.

   • To indicate that the subject’s trial terminated early, enter the date in the Early Terminated Date field.

5. Save the record.

Subject Termination Event	Automatic Field Updates
Screen Failure	The Subject record automatically updates as follows: A record with a Status field value of Screen Failure is added to the Subject Status MVG (multi value group), and the value in the Screen Failure Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Screen Failure.
Early Terminated	The Subject record automatically updates as follows: A record with a Status field value of Early Terminated is added to the Subject Status MVG, and the value in the Early Terminated Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Early Terminated.
Withdrawn	The Subject record automatically updates as follows: A record with a Status field value of Withdrawn is added to the Subject Status MVG, and the value in the Withdrawn Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Withdrawn.

When a Screen Failure or Early Terminated event occurs, all remaining visits for the subject are deleted. For more information, see the LS Subject Terminate Study Status Value 1 user property in User Properties for Business Components in Siebel Clinical.

Applying Protocol Amendments to Sites and Clinical Subjects

When you revised a protocol mid-study, apply the protocol amendments and update:

• The subject visit template version associated with the site.

• The visit schedules of any subjects who are still in the study.

Applying Revised Subject Visit Templates to Sites

This topic describes how to apply a new version of the subject visit template to a site when you revise a protocol mid-study. When you activate the new version of the subject visit template at the site, the Schedule button is enabled in the Subjects screen.

To apply a revised subject visit template to a site

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

2. In the Protocol Site list, select the site to which you want to apply a new version of the subject visit template.

3. In the Versions field, click the select button and complete the following steps:

   1. Select the new version of the subject visit template.

   2. Enter a date in IRB Approval Date field for the new version.

   3. Select the Active field for the new version.

   4. Click OK.

Applying Revised Subject Visit Templates to Clinical Subjects

This topic describes how to apply a new version of the subject visit template to a subject when you revise a protocol mid-study. When you activate the new version of the subject visit template at the site, the Schedule button is enabled in the Subjects screen.

To apply a revised subject visit template to 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 update subject visits.

3. Navigate to the Subjects view.

4. Complete one of the following steps:

   • To update the subject visit templates for all subjects at the site, click Apply Version to All.

     For all subjects at this site, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.

   • To update the subject visit templates for some subjects at the site, select the subject records, and click Apply Version to Selected.

     For the selected subjects, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.

5. In the Subjects list, drill down on the screening number field of the enrolled subject whose schedule you want to update for the revised subject visit template.

   The Visits view of the Subjects screen appears.

6. In the Subjects form, complete the following steps to enter the informed consent date for the new version:

   1. Click the select button in the Informed Consent field to open the Informed Consent Dates dialog box.

   2. Enter an informed consent date for the new version, and click OK.

7. Click Schedule, and complete the following steps:

   1. Enter the Schedule Date.

      A message appears asking if you want to delete uncompleted visits from the old version of the subject visit template and completed visits from the new version of the subject visit template. Non-applicable visits are those visits generated from the old template version that are scheduled to occur after the new Informed Consent Date and those visits generated by the new template version that have due dates prior to the new Informed Consent Date.

   2. Complete one of the following steps:

      • Click OK.

        The non-applicable visits are deleted.

      • Click Cancel.

        The new visits for the new protocol version are appended to the existing Visit Plans list. No visits are deleted. Typically, if you click Cancel, then you can return at a later stage to the Visits list and delete future-sched­uled visits from the original version of the subject visit template and past-scheduled visits from the new version of the subject visit template.

      The Subject Visits record updates as follows:

      • All the visits in the new 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.

      For more information, see Rules for Applying Protocol Amendments.

Rules for Applying Protocol Amendments

If you choose Cancel in response to the delete uncompleted visits from the old version and completed visits from the new version dialog, then a new set of visits is created and added to the visits already created from prior versions.

If you choose OK, then a new set of visits is created, the two sets of visits are compared, and the non-applicable visits are deleted when the following conditions are satisfied:

1. The subject Informed Consent date is used for the new version as a cut-off date for transitioning from the old version to the new version.

2. Equivalent Visits are those visits that have the same Visit Name.

3. For an old visit (created from the old template version) with a Completed date:

   1. If the Completed date is earlier than the Informed Consent date, then the old completed visit remains intact, and the corresponding visit from the more recent amended version is deleted. In other words, visits under the old version that are completed before an amendment takes effect are preserved, and the equivalent visits from the new version are deleted.

   2. If the Completed date is later than or equal to the Informed Consent date, then the following rules apply:

      • If the Due date of the corresponding new visit is earlier than the Informed Consent date, then the old completed visit remains intact. In other words, visits that are scheduled under the old version to complete before an amendment occurs but are actually completed later are also preserved. The equivalent visits from the new version are deleted.

      • If the Due date of the corresponding new visit is later than or equal to the Informed Consent date, then the visits from the old version are deleted, but the completed dates are copied to the equivalent visits from the new version. In addition, all child activities of the completed visits are set to Completed and have the same completed date of the parent visit. This rule applies in situations where the subject already switched to the new version before Siebel Clinical is setup in time to handle such a scenario. In such a case, the visit records generated under the old version are marked Complete instead of the visits from the new version.

4. For an old clinical visit without a Completed date:

   1. If the Due date is later than or equal to the Informed Consent date, then the visit generated from the old version of the subject visit template is deleted. In other words, future visits generated from the old version that are not yet completed are deleted, and their equivalent visits from the new version are preserved.

   2. If the Due date is earlier than the Informed Consent date, then the visit from the old version remains intact. In other words, visits under the old version that are not completed (these visits are presumably the visits that a Subject missed in the past) are preserved, and the equivalent visit from the new version is deleted.

5. For a new visit generated under the new template version:

   1. If the Due date is earlier than the Informed Consent date, then the new visit is deleted.

   2. If the Due date is later than or equal to the Informed Consent date, then the new visit remains intact, although it might still be deleted using the aforementioned rules.

Rules for Deleting Subject Visits When Deemed Non-Applicable by Early Termination

In addition to automatically deleting non-applicable visits for protocol amendments, visits that are scheduled and deemed non-applicable by early termination are deleted. Visits that are not scheduled through a template are not deleted. The following rules apply to deleting the appropriate visits:

1. Delete non-applicable, scheduled visits after a subject terminates the study.

   When the Status field of a subject is changed to Early Terminated and the Early Terminated date is populated, all future visits are deleted. Future visits are visits with a Due date and an Early Terminated date.

2. Delete non-applicable, scheduled visits after a subject fails screening.

   When the Status field of a subject is changed to Screen Failure and the Screen Failure date is populated, all future visits are deleted. Future visits are visits with a Due date and a Screen Failure date.

About Rolling Up Information for Subject Enrollment

Siebel Clinical supports clinical organizations in better managing subject enrollment for their trials in real-time. To implement this tracking, subject information is rolled up from the site level to the region level and then to the protocol level or directly from the site level to the protocol level. However, frequently this data is not available to the clinical organization, which presents significant business challenges.

For example, if organizations out source trials to CROs (clinical research organizations), then the clinical organizations cannot always receive subject level information. The enhanced subject rollup functionality provides accurate subject enrollment data at the region and protocol level, when subject level information is not available for each site or region.

Characteristics of Trials Where Subject Level Data is Available for Each Site

Trials, for which subject level information is available for each site, display the following rollup characteristics:

• Subject enrollment information is automatically rolled up from the subject level to the site level, from the subject level to the region level, and from the subject level to the protocol level.

• When a subject is the first subject to enroll for a site, region, or protocol, the date in the First Subject Enrolled field for that site, region, or protocol, is automatically populated.

• When a subject is the last subject to complete or drop off the trial for the site, region, or protocol, the date in the Last Subject Off Study field for that site, region or protocol is automatically populated.

  When you terminate a site by entering a date in the Site Termination field, the date in the Last Subject Off Study field for the site is populated with the latest date in the Completed Date field or the Early Terminated Date field of all subjects that are associated with the site. Siebel Clinical verifies that the date in the Last Subject Off Study field is later than or equal to the date in the First Subject Enrollment field. For more information, see the Last Subject Off Study Date Rollup Status n user property in User Properties for Business Components in Siebel Clinical.

  Also, the Last Subject Off Study date is automatically rolled up from the site level to the region level and from the site level to the protocol level. For more information, see the Date RollUp Fields:Region n user property and the Date RollUp Fields:Protocol n user property in User Properties for Business Components in Siebel Clinical.

Characteristics of Trials Where Subject Level Data is Not Available for Each Site

Trials, for which subject level information is not available for a site, display the following characteristics:

• You can select the No Subject Info field for sites that do not have subject level information.

• CRAs (clinical research associates) can enter information in the following fields for sites that do not have subject or site level information:

  • # Screened

  • # Re-Screened

  • # Screen Failure

  • # Enrolled

  • # Completed

  • # Early Terminated

  • First Subject Enrolled

  • Last Subject Off Study

  • Initiated Date

  • Terminated Date

• Information that you manually for sites without subject data is rolled up in the same manner as the information for sites with subject data.

Characteristics of Trials Where Site Level Data is Not Available for a Region

Trials, for which site level information is not available for a region, display the following characteristics:

• The No Site Info field is selected for regions that do not have site level information. You do not have to select the No Subject Info field.

• CRAs (clinical research associates) can enter information in the following fields for regions that do not have site level information:

  • # Screened

  • # Re-Screened

  • # Screen Failure

  • # Enrolled

  • # Completed

  • # Early Terminated

  • First Subject Enrolled

  • Last Subject Off Study

  • Initiated Date

  • Terminated Date

  • First Site Initiated Date

  • Last Site Terminated Date

• Information that you manually for regions without site data is rolled up in the same manner as the information for regions with subject data.

Viewing Status Accruals for Clinical Subjects of Sites

Clinical subject data is automatically rolled up to the clinical site record. The Status Field RollUp user properties determine the criteria for the automatic rollup of subject status accruals to the clinical site record. For more information about these user properties, see User Properties for Business Components in Siebel Clinical.

You must select the Status Tracking Visit field (in the Visits list in the Visit Templates view of the Administration - Clinical screen) to automatically create subject status accruals for pairs of a visit type value and a subject status value. For more information about the Status Tracking Visit field, see Defining Subject Visits.

The task in this topic describes how to view subject status accruals for each visit type and subject status of a clinical site.

To view status accruals for clinical subjects of a site

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 view subject accruals.

3. Navigate to the Subject Status Accruals view.

   Some fields are described in the following table.

   Field	Comments
   Visit Type	Displays a type of clinical subject visit that is associated with the site, such as Screening, Re-screening, or Enrollment.
   Status	Displays a subject status that is associated with the site, such as Screened, Re-screened, or Enrolled.
   Total Accrual Number	Displays the number of site subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects and for which these same values applied to the subjects in the past.
   Current Accrual Number	Displays the number of site subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects. The value in the Visit Type field and the value in the Status field currently apply to records in the Subject Status MVG (multi value group) for which the Primary field is selected. You see the Subject Status MVG when you click the select button in the Status field of the subject record.

Viewing Status Accruals for Clinical Subjects of Clinical Regions

Clinical subject data is automatically rolled up to the clinical region record. The Status RollUp Fields: Region user properties determine the criteria for the automatic rollup of subject status accruals to the clinical region record. For more information about these user properties, see User Properties for Business Components in Siebel Clinical.

You must select the Status Tracking Visit field (in the Visits list in the Visit Templates view of the Administration - Clinical screen) to automatically create subject status accruals for pairs of a visit type value and a subject status value. For more information about the Status Tracking Visit field, see Defining Subject Visits.

The task in this topic describes how to view subject status accruals for each visit type and subject status of a clinical region.

To view status accruals for clinical subjects of a clinical region

1. Navigate to the Regions screen, then the Region List view.

2. In the Region list, drill down on the Region field of the region for which you want to view subject accruals.

3. Navigate to the Subject Status Accruals view.

   Some fields are described in the following table.

   Field	Comments
   Visit Type	Displays a type of clinical subject visit that is associated with the region, such as Screening, Re-screening, or Enrollment.
   Status	Displays a subject status that is associated with the region, such as Screened, Re-screened, or Enrolled.
   Total Accrual Number	Displays the number of region subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects and for which these same values applied to the subjects in the past.
   Current Accrual Number	Displays the number of region subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects. The value in the Visit Type field and the value in the Status field currently apply to records in the Subject Status MVG (multi value group) for which the Primary field is selected. You see the Subject Status MVG when you click the select button in the Status field of the subject record.

Viewing Status Accruals for Clinical Subjects of Clinical Protocols

Clinical subject data is automatically rolled up to the clinical protocol record. The Status RollUp Fields: Protocol user properties determine the criteria for the automatic rollup of subject status accruals to the clinical protocol record. For more information about these user properties, see User Properties for Business Components in Siebel Clinical.

You must select the Status Tracking Visit field (in the Visits list in the Visit Templates view of the Administration - Clinical screen) to automatically create subject status accruals for pairs of a visit type value and a subject status value. For more information about the Status Tracking Visit field, see Defining Subject Visits.

The task in this topic describes how to view subject status accruals for each visit type and subject status of a clinical protocol.

To view status accruals for clinical subjects of a clinical protocol

1. Navigate to the Protocols screen, then the Protocol List view.

2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to view subject accruals.

3. Navigate to the Subject Status Accruals view.

   Some fields are described in the following table.

   Field	Comments
   Visit Type	Displays a type of clinical subject visit that is associated with the protocol, such as Screening, Re-screening, or Enrollment.
   Status	Displays a subject status that is associated with the protocol, such as Screened, Re-screened, or Enrolled.
   Total Accrual Number	Displays the number of protocol subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects and for which these same values applied to the subjects in the past.
   Current Accrual Number	Displays the number of protocol subjects for which the value in the Visit Type field and the value in the Status field currently apply to the subjects. The value in the Visit Type field and the value in the Status field currently apply to records in the Subject Status MVG (multi value group) for which the Primary field is selected. You see the Subject Status MVG when you click the select button in the Status field of the subject record.

Monitoring Rates for Subject Enrollment

The Subject Status feature in the Charts view provides a graphical representation of subject enrollment rates. You can display the charts by protocol, region, or site, and in a variety of pie chart and bar chart formats.

To monitor rates for subject enrollment

1. Navigate to the Protocols, Regions, or Site Management screen.

2. In the list, select the record for which you want to create the charts.

3. Navigate to the Charts view.

4. Select values from the drop-down lists as follows:

   1. From the first drop-down list, select Subject Status.

   2. From the second drop-down list, select Subject Enrollment Rates.

   3. From the third drop-down list, select the time frame.

   4. From the fourth drop-down list, select the display type, such as bar chart or pie chart.

5. Click Go.

Monitoring Status Accruals for Clinical Subjects by Visit Type

The Subject Status Analysis feature in the Charts view provides a graphical representation of subject status accruals by visit type. You can display the charts by protocol, region, or site, and in a variety of pie chart and bar chart formats.

To monitor status accruals for clinical subjects by visit type

1. Navigate to the Protocols, Regions, or Site Management screen.

2. In the list, select the record for which you want to create the charts.

3. Navigate to the Charts view.

4. Select values from the drop-down lists as follows:

   1. From the first drop-down list, select Subject Status Analysis.

   2. From the second drop-down list, select Subject Accruals.

   3. From the third drop-down list, select the time frame.

   4. From the fourth drop-down list, select the display type, such as bar chart or pie chart.

5. Click Go.

Using Audit Trail for Changes to Subject Status

The Status Audit Trail view provides a detailed history of the changes to Subject Status records, including the dates and times of the changes and details of the users who make the changes.

To use the audit trail for changes to subject status

1. Navigate to the Subjects screen, then the Subject List view.

2. In the Subject list, drill down on the screening number field of the subject.

3. Navigate to the Status Audit Trail view.

   Some fields are described in the following table.

   Field	Comments
   Employee Login	Displays the username of the user who changed the record.
   Business Component	Displays the business component for the record where the database change occurred.
   Field	Displays the name of the field where the change occurred.
   Operation	Displays the type of operation that was performed, for example, New Record, or Modify.
   Old Value	Displays the value in the field before the database change occurred.
   New Value	Displays the value in the field after the database change occurred.
   Date	Displays the timestamp of the change.
   Record ID	Displays the unique identifier of the record that was changed.
   Base Table	Displays the name of the primary database table where the database change occurred.
   Column	Displays the name of the column in which the change occurred.
   Group ID	Displays the unique identifier of the group to which the user who changed the record belongs.
   Node	Displays the name of the database table node where the change occurred.
   Table	Displays the name of table to which the selected field belongs in the Siebel database.
   Row ID	Displays the unique identifier of the row in which the change occurred.
   Employee ID	Displays the unique identifier of the user who changed the record.

Generating Oracle BI Publisher Reports for Site Enrollment Status

You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. The preconfigured Site Enrollment Status report applies clinical trials. For more information about using Siebel Reports, and integrating with Oracle BI Publisher, see Siebel Reports Guide.

To generate an Oracle BI Publisher report for the site enrollment status

1. Navigate to the Protocols screen, then the Protocol List view.

2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate an Oracle BI Publisher report.

3. Navigate to the Sites view.

4. On the application toolbar, click Reports.

5. In the Run Report pane, complete the appropriate fields.

   Some fields are described in the following table.

   Field	Comments
   Report Name	Select the Site Enrollment Status report.
   Output Type	Select the output type for the report.

6. Click Submit.

   The report runs.

7. Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.

   A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.