Consent Forms

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Consent Forms

The Consent Module contains two submanagers: Consent Form and Patient Consent. From these two managers, users will be able to define consent forms in the system and enter consent information for an existing subject.

The consent form editor allows users to modify all aspects of a consent form. Users need permission to access this module.

Typical Consent form creation workflow:

Create a New consent form → Define the Consent Form Properties → Add Consent Form Fields → Enter Consent Form Field and Value Properties → Add Consent Form Verifiers → Save

When the user first opens the Consent Form editor, the Consent Form Properties panel will be displayed, including the fields described below.

The Field Properties and Value Properties tabs in the Consent Form editor each allow users to set information about the consent form field they are adding. The Field Properties tab deals with general properties of the field. The Value Properties tab allows users to set which values will be accepted in the Patient Consent editor for each field.

Consent Form Properties

Study ID: This field displays the study the consent form name originally entered in the Consent Form Specification dialog. This value is populated when the user first enters a Study ID when creating a new consent form. This field is not editable after the initial creation of the consent form.

Form Name:  This is the Form Name originally entered in the Consent Form specification dialog. This field will remain editable after the initial creation of the consent form.

Date Created: This field shows the date that the consent form was initially created. The field is not editable and is automatically populated by the system.

Date Last Modified: This field shows the date that the consent form was last edited. This field is not editable and is automatically populated by the system.

Created By:  This field shows who initially created the consent form. This field is not editable and is automatically populated by the system.

Status: The status field will automatically default to Active when a consent form is created. Users will have the option to change the consent form status to Inactive. When a status of Inactive is chosen, the consent form will no longer be available for adding patient consent data to the system. This field is always editable.Consent Form Properties

Field Properties

On the Field Properties Tab, users can edit the following information:Consent Field Properties

  • Field Name: This field is a required field. The value entered here will appear on the Patient Consent editor as the field name. The Field Name will also be used to name the field in the Consent Form tree in the Consent Form Editor.
  • Is Required: This checkbox allows users to denote whether the field will be required on the Patient Consent editor. If this field is checked, users will receive an error in the Consent Form editor if the field does not have a value. If the field is optional, this checkbox should remain unselected.
  • Description: This field is provided so that any additional information for users can be shown in the Patient Consent editor. This description will appear in a ToolTip or in the Field Properties dialog in the Patient Consent editor (depending on the view type). This field is not required.
  • Field Type: This field is required. The following fields are available for the user to choose from for this field:
    • Characters
    • Boolean *Note: This field type indicates that the field added is a consent bearing field. This field will be used for consent verification in requisitions and requires a value to be entered in the Questions field in the Consent Form editor. If a False/No value is entered in the Patient Consent editor for a Boolean field, then the system will give a warning that the patient has not consented when associated patient specimens are added to requisitions.
    • Choice
    • Date/Time
    • Integer
    • Decimal
    • Multi-Choice
    • Scientific Notation
    • Attachment
  • Is Active: This field determines whether the field appears on the Patient Consent editor. This field will be automatically checked.
  • Question: When a Field Type of Boolean is chosen, this field is required. Users should use this field to fill in consent questions from the consent forms.
  • Display Order: This field determines the order in which the fields are displayed in the Patient Consent editor. This field will automatically be filled in when a new field is added in the Consent Form editor.

Value Properties

On the Value Properties tab, users can define the following properties for each Field Type:

  • Characters: Field length and the valid characters for the field allowed in the Patient Consent editor.

  • Date/Time: Users can indicate whether future dates can be entered for this field in the Patient Consent editor. The Allow Future Dates checkbox is automatically checked. The time will be listed in the form "00:00" and may be added by typing in four numeric characters after a space at the end of the date portion of the field.

  • Integer: The minimum and maximum values allowed in the Patient Consent editor.

  • Decimal: The minimum and maximum values allowed in the Patient Consent editor. Also, the number of decimal places allowed in the Patient Consent editor.

  • Scientific Notation: The minimum and maximum exponent values. As well as, the number of allowed decimal places and whether users will be able to enter negatives in the Patient Consent editor.

  • Choice and Multi-Choice: Users will be about to fill out a table that creates the code list users can choose values from in the Patient Consent editor. The following fields will appear in the code list table:

    • Value
    • Label
    • Description
    • Required Value: This field is only used if the field type is Multi-Choice. Setting this field to True/Yes requires the user to enter a value when this selection is chosen from the code list in the Patient Consent editor.

Create a Consent Form

Users can create a new consent form from the Consent Form manager using the New button. This will open the consent form editor where users can define consent form fields and specify verifiers.

To add a new consent form:

  1. Select New from the Consent Form manager. The Consent Form Specify Identification for Definition dialog will open. Users will be prompted to fill in the Form Name and Study ID for the new consent form.New Consent Form
  2. Press OK on the Specify Identification for Definition dialog to open to Consent Form editor.
  3. When the Consent Form editor opens, enter the desired information, then press the Save button on the toolbar or under the File menu.Consent Save button
  4. The Consent Form will be saved. Close the Consent form by clicking the X button on the top right of the editor, choosing Close from the File menu, or pressing Alt + F4.

View a Consent Form

Users have the option to view an existing consent form in the editor. When the consent form is open in View mode, users will not be able to make any changes to the consent form.

To view an existing consent form:

  1. Select the desired consent form from the Consent Manager by clicking to highlight the form.
  2. Press the View button on the right side of the manager.
  3. The selected consent form will open in the Consent Form editor in View mode.View Consent Form

Edit a Consent Form

Opening a consent form in Edit mode allows users to make changes to an existing consent form and save them.

To edit an existing consent form:

  1. Select the desired consent form from the Consent Form manager by clicking to highlight the form.
  2. Press the Edit button on the right side of the manager.Edit Consent Form
  3. The selected consent form will open in the Consent Form editor in Edit mode. Make the desired changes to the consent form. See the Consent Form Field and Value Properties article for specific fields that can be edited.
  4. Once the changes have been made, press the Save button on the toolbar or choose Save from the File menu to save your changes.
  5. To close the consent form editor, click the X button on the top right of the editor, choose Close from the File menu, or press Alt + F4.

Duplicate a Consent Form

The Duplicate button on the Consent Form manager allows users to create a new consent form with the same fields and verifiers as an existing consent form.

To duplicate a consent form:

  1. Highlight the consent form to be duplicated in the Consent Form manager.
  2. Press the Duplicate button on the right side of the manager.Duplicate Consent Form
  3. The Specify Identification for Definition dialog will open. Choose a Study ID and fill in a Form Name.Consent Specify Identification
  4. Press the OK button. The Consent Form editor will open with a duplicate of the selected consent form.

Delete a Consent Form

To delete an existing consent form:

  1. Select the desired consent form from the Consent Form manager by clicking on it.
  2. Press the Delete button.Delete Consent Form
  3. Users will be presented with the delete confirmation dialog. Pressing No on the delete confirmation dialog will close the dialog without deleting the form.  Pressing Yes on the delete confirmation dialog will do the following:
    • If the consent form does not have patient consent data associated with it, the consent form will be deleted and the manager will refresh.
    • If the consent form does have patient consent data associated with it, a note will appear informing the user that it cannot be deleted because patient consent data has already been filled out. The consent form will then be set to Inactive. When the consent form has a status of Inactive, then users will not be able to use the form to create new patient consent data. However, any existing consent restrictions that have been entered for the Inactive form will be preserved.

Consent Form Fields

Adding Fields

Users can define the fields that will be shown in the Patient Consent editor.

To Add a Consent Form Field:

  1. Press the Add Field button on the toolbar or choose the Add Field option from the Edit menu. A new field will be entered on the Consent Form tree and the Field Properties tab will open.Add Consent
  2. On the Field Properties tab, define the desired information. See the Consent Form Field and Value Properties article for definitions of each field.Consent Form Field Properties
  3. On the Value Properties tab, define the acceptable values for each field type, if desired. See the Consent Form Field and Value Properties article for an explanation of the properties that can be set.
  4. When finished editing, press Save on the toolbar or choose Save from the File menu.

Edit Fields

To edit an existing Consent Form field:

  1. Find the name of the Consent Form field in the tree on the left side of the editor under Consent Form and click to highlight it.Edit Consent Form Fields
  2. The Field Properties for that field will open in the right panel. Edit the desired information.
  3. Press Save when finished editing the consent form field.

Delete Fields

To delete an existing consent form field:

  1. Find the name of the Consent Form field to be deleted in the tree on the left side of the editor under Consent Form and click to highlight.
  2. Press the Delete Field button on the toolbar or click the Delete Field option under the Edit menu.Delete Consent Form Fields
  3. The field will be deleted. Press Save to save the changes.

Consent Form Verifiers

Add Verifiers

To add a consent form verifier:

  1. Press the Add Verifier button on the toolbar or choose Add Verifier from the Edit menu. A new verifier will open in the right panel of the Consent Form editor.Add Consent Form Verifier
  2. Fill in the following information for the Verifier:Consent Verifier
    • Name: This will name the verifier in the Consent Form tree.
    • Severity: There are two options for this field—Warning and Error. The value chosen for this field will determine what type of message is generated if the verifier criteria are not met in the Patient Consent editor. If Warning is chosen, then users will be able to save even when there are violations of the verifier criteria (the warning message will still appear though). If Error is chosen, users will not be able to save the Patient Consent editor when violations of the verifier criteria are present
    • Message: This field allows users to enter the message that a user will see when they violate the verifier criteria in the Patient Consent editor. This field is required.
    • Below the fields listed above is a panel that is similar to the Standard Search dialog. This panel will be used to define the verifier. In the Fields section, only fields that have already been added to the Consent Form tree will be available. Highlight the field you would like to add a verifier to. Using operators and the values field, you will be able to define when a warning or error will appear.Search verifier dialog panel
  3. Press Save when finished.

Users can test that the verifier criteria is entered correctly by pressing the Test button. The Test button appears on the right of the verifier Criteria panel. This button will launch a dialog with the consent form fields appearing as they would in the Patient Consent editor. Users can enter example values in these fields to see which values will produce a warning/error to test that their verifier criteria is set correctly.

Example: Dr. Pascal adds custom fields to the consent manager so that he knows which subjects are willing to participate in concurrent studies and which subjects have been admitted to a hospital between visits. He sets up verifiers so that a warning will be displayed for specimens of a subject who has not consented to particular procedures.

Edit Verifiers

To edit an existing consent form verifier:

  1. Find the name of the desired Consent Form verifier in the tree on the left side of the editor under Verifiers and click to highlight.Consent form verifier
  2. The Verifier Properties will open in the right panel. Edit the desired information.
  3. Pres Save when finished editing the verifier.

Delete Verifiers

To delete an existing consent form verifier:

  1. Find the name of the desired Consent Form verifier in the tree on the left side of the editor under Verifiers and click to highlight.
  2. Press the Delete Verifier button on the toolbar or select Delete Verifier from the Edit menu.Delete consent verifiers
  3. The verifier will be deleted. Press Save to save the changes