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Consent forms are configured at a CP level . The consent form is configured in HTML and can contain the following:

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Prerequisites

Consent Statements

Consent statement should be defined in the “Consents” module. 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.

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The consent form could have fields like consent witness, consent date, eSignatures etc. These fields are to be added in a Consent Custom Fieldscustom 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 CP CPs and making it easy for reporting.

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Consent form is designed in HTML HTML since it gives us the flexibility to easily format the consent form. E.g. bullet points, bold, underline, embed videos/photos, etc.

There are three sections in the Consent Formconsent form:

  1. Formatted text

  2. Consent statements

  3. Custom fields

Info

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.

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Consent Statements

Consent statement(s) can be added anywhere in the consent form. They can be displayed as a dropdown, radio-button, or checkbox.

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<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 as the consent form using the below steps.

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titleAdding a consent document to the CP
  1. From the navigation menu, go to Collection Protocols list page > CP Overview > Consents tab

  2. User is redirected to the list page of the CP level consents. Click on “Add”.

  3. 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”.

  4. It will be visible at the end of the consent statements in the list view.

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The order of consent documents can be changed using the “Sort” option. This is to sort the consent forms in a specific order. If no order is specified, the system will displayed in the order the forms are uploaded.

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titleSteps to re-order the consent documents
  1. Go to CP Overview > Consents > Sort

  2. Enter the sort order starting from 1. Click “Update”.

  3. While choosing to add the consents for a participant, these documents appear in the same order as specified.

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