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.

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.
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.
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.

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.
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.
3. The Specify Identification for Definition dialog will open. Choose a Study ID and fill in a Form Name.
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.
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.
2. On the Field Properties tab, define the desired information. See the Consent Form Field and Value Properties article for definitions of each field.
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.
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.
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.
2. Fill in the following information for the 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.
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.

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.
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.
3. The verifier will be deleted. Press Save to save the changes