Summary

This article describes the management, tracking and accessing of the subjects enrolled in the trial using the subject manager.

Table of Contents

• Access Subject Manager
• Progress Bars
  • Tracked Metadata and Available Statuses
  • Color Coding and Form Links
    • SDV, Frozen, Data Reviewed, Locked, and Signed Statuses
    • Answer Status
    • Alert and Query Status
• Manager-Level Actions
  • Apply and Clear Metadata Statuses
  • Manipulate Subjects and Casebooks
    • Delete Subjects
    • Restore Subjects
    • Additional Actions
• Available Columns and Filter Types

The Subject Manager allows for the management, tracking and accessing of the subjects enrolled in the trial. It provides visibility into the progress being made in each subject casebook.

Access Subject Manager

Within a study click ‘Subjects’ in the Hamburger Menu to access the Subject Manager.

Progress Bars

Some columns in the Subject Manager table will be displayed as progress bars. These allow you to track the percentage of questions in a subject’s casebook that have certain metadata statuses applied to them.

Tracked Metadata and Available Statuses

Only those metadata that develop progressively within a casebook are tracked in this manner. Each of these metadata have a set of statuses describing a form’s state with regard to that particular metadata. These are described in the table below:

Color Coding and Form Links

The progress bars are color coded to indicate how much progress has been made. What the colors indicate varies slightly with the particular metadata that they are representing. Additionally, colored portions of these bars can be clicked to view the entry in a more specific manager with automatically configured filters. Subject Manager links will redirect you to the Form Manager in most cases, with the exceptions being Alert and Query Status which link to their own respective managers.

The color coding scheme and this linking format are described below:

SDV, Frozen, Data Reviewed, Locked, and Signed Statuses

Green

• Indicates the action has been completed, and the status is applied to a form.
• Clicking the green portion of the progress bar redirects to that subject’s entries in the Form Manager and applies the filters [Action Completed] + Partially [Action Completed] applied. (e.g. Verified + Partially Verified)

White

• Indicates that the action is either unnecessary or not ready to be executed on a form.
• Clicking the white portion of the progress bar redirects to that subject’s entries in the Form Manager and applies the filters Not Ready to be [Action Completed] + Partially [Action Completed]. (e.g. Not Ready to be Verified + Partially Verified)

Red

• Indicates that the action is needed or ready to be executed on a form.
• Clicking the red portion of the progress bar redirects to that subject’s entries in the Form Manager with the filter [Action] Needed set.

Answer Status

Green

• This indicates that data has been entered and marked as complete.
• Clicking on the green segment of the progress bar will redirect you to that subject’s entries in the Form Manager and apply the filters Completed + Partially Completed.

White

• Indicates that data has not yet been entered.
• Clicking on the white segment of the progress bar will redirect you to that subject’s entries in the Form Manager and apply the filters Blank + Partially Completed.

Red

• Indicates that data has been entered, but has not yet been flagged as completed.
• Clicking the red segment of the progress bar will redirect you to that subject’s entries in the Form Manager and apply the filter Completion Needed.

Alert and Query Status

Green

• Indicates that the alert or query is closed.
• Clicking the green segment of the progress bar will redirect you to that subject’s entries in the Alert or Query Manager and apply the filter [Alert or Query] Status: Closed.

White

• Indicates that no open or closed queries exist.
• When this progress bar is white, it is not linked to any other pages.

Red

• Indicates that there are open queries or alerts.
• Clicking the red segment of the progress bar will redirect you to that subject’s entries in the Alert or Query Manager and apply the filters New + Reopened + Answered.

Manager-Level Actions

Certain actions are provided to the user by way of the dropdown actions bar in the Manager Table. These actions are differentiated from those available in the green ‘Actions’ tab at the top-right corner of the screen in that they are applicable to both individual records and groups of records selected from the table. These are described below.

Apply and Clear Metadata Statuses

For the Subject Manager, Form Manager, and Question Manager which deal with patient casebook records, the actions allowing metadata statuses to be added or removed from forms are available.The following steps apply to the following actions: Complete, Clear Complete, SDV, Clear SDV, Lock, Unlock, Freeze, and Unfreeze, Sign, Clear Signature, Data Review, Clear Data Review.

To execute these actions:

1. Click the checkboxes next to the patient records that you wish to apply the status to.
2. Choose the action you wish to apply from the dropdown menu in the manager table.
3. A second dropdown menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
   You will be redirected to a confirmation page.
5. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct
6. Click ‘Yes’ to complete the action or ‘No’ to cancel the action.
7. If you are signing documents, you will be redirected to an additional page where you must enter your login credentials to complete the operation.

Executing these actions at the manager or form-summary level carries the effect of applying a status to both the record displayed in the table and all of the sub-forms beneath it. This means that if you SDV a record at the level of the Subject Manager, that status will be applied to the entire casebook (because entries in the Subject Manager are subject casebooks), including all forms and questions contained within.

Note: If you modify any finalized data (Green Status), the system invalidates all SDV, Completion, and Data Review statuses and Signatures. 

Manipulate Subjects and Casebooks

Delete Subjects

When subjects are created in error, they can be deleted by those with appropriate permissions.

1. Navigate to the subject that should be deleted and click the checkbox next to the appropriate items.
2. In the dropdown menu, select ‘Delete Checked.’
3. A second dropdown menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
   You will be redirected to the ‘Confirm Delete Record’ page.
5. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
6. Enter a reason for the deletion.
7. Click the ‘Ok’ button to complete the action or ‘Cancel’ to cancel the action.

Restore Subjects

If subjects are deleted in error, they can also be restored.

1. In the Deleted Status filter table, remove ‘Active’ option by clicking the ‘x.’
2. Click the Deleted Status filter to add the ‘Deleted’ option to the list of options.
3. In the Filter Table, click the ‘Search’ button.
4. Click the checkbox next to the subjects that should be restored.
5. In the dropdown menu, select ‘Restore Checked.’
6. A second dropdown menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
7. Click the ‘Go!’ button to the right of the second dropdown menu.
   You will be redirected to the ‘Confirm Restore Record’ page.
8. Enter a reason for the restore.
9. Click the ‘Restore’ button to complete the action or ‘Cancel’ to cancel the action.

Additional Actions

Additional actions related to mid-study configurations, dynamic statuses, subset exports, filling sample data and working with subject statuses may also be available depending on the trial configuration.

Available Columns and Filter Types

The Subject Manager has many columns that can be dragged and dropped between the Manager and Filter Tables. The values of certain columns also serve as links to the Casebook. The following table defines each column, the actions made available through the column value and the filters and sorts available.

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