Adding and Editing a consent form

This article explains how to add new consent forms, edit or delete existing ones.

To add a new form, navigate to the ‘Consent Forms’ page and follow these steps:

1. Click on the ‘Add consent form’ button. 

2. In the ‘Create New Consent Form’ window, specify the details of the consent form.

3. Click ‘Create New Form’ to create a form. Once the form is created, the status of the form will be changed to ‘Draft’ and it will be displayed in the Consent Forms overview.

Once the form is created, you need to add the form text and set the relevant form properties. This can be done in the ‘Content’ and ‘Settings’ tabs. It is also possible to Preview your form and Download it in pdf format.

Content

On the ‘Content’ page, you are able to define the form text, add checkboxes and signature statements, and preview and publish your consent form.

Form text: here you can include the form text and format the text

Subject agreements: add subject agreements for the subject to check before signing.

To manage subject agreements, click on the pencil icon:

Here you will be able to edit  or delete the existing agreements, and add new ones.

1. Subject agreement description

2. Label of the agreement: the label is valid for the Subjects overview, so you can see at a glance whether a participant ticked that box before signing. 

Note: You can only add labels to optional agreements.

3. When adding a new agreement, you need to specify whether it is required by ticking the 'Required' checkbox, include the agreement statement and its label. 

4. The subject agreement statement allows to define the description of the agreement.

5. 'Add another agreement' button allows to add additional agreements to your form.

6. Click on 'Save changes' button to proceed with the changes or 'Cancel' to revert the changes.

7. Click on the bin icon to delete the subject agreement.

Signature Statements

In this section you can define signature statements for subjects and study team members. The needed signatures on the consent forms can be configured for each form.  

Subject Section

In this section you can define subject signature statements.  

Some documents only require a subject signature and no counter signature by a study team member. It is possible to define only subject signature statement. Once a subject has signed the ICF that does not include a study team member signature, the consent status of the form is set to ‘Consented’ as it is fully signed. 

When editing a form, you need to click on the ‘Save changes’ button to make sure that all the changes are saved. 

The default header for the subject signature component on the ICF labeled as “Subject signature” is  editable. This allows sponsors to use their own wording (for example “Participant signature”) and to support different ICF languages better.

To edit the subject signature header and the signature statement:

1. Click on the pencil icon:

2. Adjust the signature header and the: signature statement and click the 'Save changes' button to apply the changes:

Study team member Section

This section allows to add, customize or delete study team member signatures.

• It is possible to have none or maximum two study team signatures. When only one signature is added, it will be set to 'Required' by default.  The headers of the study team member signatures are configurable per ICF template.

• A second study team member signature can be added to the ICF template by clicking on the 'Add study team signature' button. 

• This second signature can be setup as:

  • Required - The second study team member signature component always needs to be signed before the ICF is set to completely signed (status ‘Consented’);

  • Optional - If it is unknown upfront whether a second study team member signature is needed for a specific form or subject, the second signature can be marked as optional. In that case, the second study team member signature component needs to be (de)activated by the first study team member that signs the ICF. If the signature component is deactivated, it can no longer be signed. If the signature component is activated, it has to be signed before the ICF is set to completely signed (‘Consented’).

• The section  ‘Additional signature(s) details’ in the ‘Consent form (most recent)’ card on the profile page of the subject  displays the consent status of the additional signature, the header name of the additional signature, and whether a notification has been sent.

• When there is a required second signature component, or an activated optional second signature component, a signature can be requested by sending an email notification.

• Once a second signature component is activated by mistake, this component can be deactivated again via the action by clicking on the three dot menu of the ICF. This also works the other way around; a deactivated signature component can be activated again.

• The second study team member signature component can be signed by users with sign rights. The second signatory cannot be the same as the one who is required to sign on the first signature component.

• Activating or deactivating the signature components is logged on the audit trail.

Publishing the form

Once you have finished editing the form, you can publish the form by clicking the ‘Publish’ button. Once the form is published,  it will no longer be possible to edit the content. Please ensure you have completed the necessary review and approval processes prior to publishing. Click ‘Publish now’ to publish the form. You can still modify the form settings after publishing.

Settings

In the ‘Settings’ page, you can change the form settings such as Form name, Country, Site(s), Language, Version number and Version date.