Introduction
Consent forms are configured at a CP level in HTML and can contain the following:
Formatted text
Consent Statements
Custom fields
Prerequisites
Consent Statements
The consent statements are defined at a global level so that they can reused across CPs. Go to Menu->Consents to define new consent statements. Refer to Coded Consentsfor more details.
Custom Fields
The consent form could have fields like consent witness, consent date, eSignatures etc. These fields are to be added in a custom form attached at “Consent Document Custom Fields” level. A single form is maintained for consent custom fields across the system to avoid duplicating fields across CPs and making it easy for reporting.
Refer to Create and Edit Formfor details on how to create a new form.
Refrain from adding duplicate fields. For example, ‘participant name’ is the same as the ‘patient name’.
Designing the Consent Form
Consent form is designed in HTML since it gives us the flexibility to easily format. E.g. bullet points, bold, underline, embed videos/photos, etc.
There are three sections in the consent form:
Formatted text
Consent statements
Custom fields
You need to know how to use HTML formatting to be able to create consent forms. You can use online HTML editors like this to create this section.
Formatted text
This section applies to any informative text that has to be included in the consent form. For example, see below.
Consent Statements
Consent statement(s) can be added anywhere in the consent form. They can be displayed as a dropdown, radio-button, or checkbox.
For example:
Custom Fields
Details such as signature, date of signature etc. that were defined in the custom form (step 2 in the “Prerequisites”) can be displayed as below in the consent form.
Example Consent Form
<HS: include the complete HTML for download here>
Adding the Consent From to a CP
Once the HTML is ready, you can upload it for a CP using the below steps.
From the navigation menu, go to Collection Protocols list page > CP Overview > Consents tab
User is redirected to the list page of the CP level consents. Click on “Add”.
Enter the name of the consent document in the “Title” field, the version in the “Revision” field and upload the HTML file in the “Document File” field. All three fields are mandatory. Click on “Add”.
It will be visible at the end of the consent statements in the list view.
Updating a Consent Form
The title, version and the HTML content can be updated. It can be done by clicking the “Edit” icon from the consents list page.
Go to the CP Overview > Consents
Click on the “Edit” icon beside the consent document
If you want to update the title and version, just update the fields and click update. No need to re-upload the document.
In case an updated document is to be uploaded, leave the other fields unchanged. Upload the document and click “Update”.
Consent Versioning
A consent document can have multiple versions. When a new version is added, the new version is available for old and new participants. The data collected for older version remains in the database and is available for querying.
From the consents list page, click on the “+” icon across the document
Enter the version of the consent document. Upload the document and click “Add”
Archiving Consent Form
In case a version of consent form is not needed anymore, it can be archived. Once archived, the form is not available anymore. However, if consent is already collected for that version, then it is available for viewing, edit and reporting.
Download Consent
The consent form’s HTML file can be downloaded and used to editing the form or uploading it another instance or another CP. This saves the re-work of designing the document from scratch.
Sort Consents
The order of consent documents can be changed using the “Sort” option. If no order is specified, the system will displayed in the order the forms are uploaded.
Go to CP Overview > Consents > Sort
Enter the sort order starting from 1. Click “Update”.
While choosing to add the consents for a participant, these documents appear in the same order as specified.
