How to add a consent to a trial?

1. Open: Consents

   Within your selected trial, click on the “Consents” tab located on the left side of the screen. This will show you a list of all consents currently associated with your trial.

2. To create a new consent:

   • Click the plus (+) button in the top right corner of the screen to open the consent creation page.
     
     

3. General Information Panel:

   • Name: Enter the name of the consent. This field is required with a maximum of 64 characters. The name must be unique and no procedure with the same name can be added.
   • Type:
     • Mandatory: This is a fixed, required consent that follows the protocol.
     • Additional: This allows you to create supplementary consents. If you choose "Additional," you'll be required to select the related procedures.
   • Related Procedure:
     • If you select the Additional type, choose the related procedure(s) from a multi-select list of trial procedures. This field is inactive for Mandatory type and required for Additional type.
   • Valid from: Select the start date for when the consent becomes valid using the date picker. This field is mandatory.
   • Protocol Number: Enter the protocol number. This is a mandatory field with a maximum of 64 characters.
   • Blinding: Select the blinding option (e.g., Blinded, Unblinded). This field is mandatory.
   • Performer: Choose the performer role responsible for this consent. This field is also mandatory.

4. Adding Elements to the Consent:

   • Tabs: There are two main tabs for adding sections to the consent:

     • Signing form: For collecting signatures from trial participants.
     • Withdrawal form: For cases where a participant might want to withdraw consent.

   • Note: You must add at least one element to each section for the consent to be valid.

5. Adding Fields:

   • Access the “Add” section: Use the "Add" button to start adding fields to your consent.

   • You have the option to add three types of fields:

     • Individual fields created at the network level.
     • Custom fields (fields defined for this specific consent).
     • Generic fields (predefined fields available for general use).

   • Search and Filter: You can search the list of available fields dynamically by typing at least one character. You can also filter the list by Type, Domain, and Source.

   • Hover over the info button next to each field to see detailed information about it.

6. Managing Fields:

   • Once added, you can:
     • Change the position of a field using drag-and-drop functionality.
     • Delete a field if it’s not required.
     • Edit a field by clicking on it to adjust its settings or mark it as mandatory.
     • Adjust the field's width: Choose from 25%, 33%, 50% (default), or 100% width to suit the form design.

7. Completing the consent form:

   • After adding all the necessary fields, review your consent to ensure all information is complete.
   • The status toggle button at the top should be set to Active by default, indicating that the consent is ready for use.

8. Saving the consent:

   • Click Create to save the consent and add it to the list of consents inside the trial.
   • If you wish to cancel, click the Cancel button, which will return you to the list of consents without saving.
     
     
     
     

Important Notes:

• You must add at least one element in both the Signing form and Withdrawal form sections for the consent to be valid.
• All consents added will be listed in the Consents tab, and you can edit any of them by clicking on their names.
• Consents are available only at trial level.