How to set up the eConsent feature in Climedo?

Learn how to set up Climedo to send and sign eSignatures for eConsent.

Please note that this feature is only partially self-service. Please contact your Customer Success Manager if you wish to use this feature. The following parts require the involvement of Climedo's Tech department and some information must be provided by the customer in advance: 

1. Set-up of the consent document in YouSign® ▶️ Consent file needs to be provided by the customer.
2. Set-up of signature request emails and reminder emails in YouSign® ▶️ Custom Email texts need to be provided by the customer.
3. Set-up of the Webhook in your Climedo instance to collect all signature information from YouSign®.
   
   

The below steps describe the self-set-up and usage guidelines of this feature within Climedo: 

1. Step 1 - General

2. Step 2 - Assigning the required eConsent rights

Assign eConsent sending and signing rights under Access - Roles - Subject Right to your collaborators that should be eligible to digitally send and/or sign a consent form
Read: Collaborators are able to see the columns "Consent type", "Consent status" and "Consent name" in the subject overview without being able to change anything in the implementation itself.  If the collaborator does not have the right to at least read the subject files, they cannot see or open the finished eConsent document.
Send: Collaborators can send a signature request to the patient and the signee (usually the doctor who conducted the pre-study discussion).  Collaborators can assign and change eConsent signees of subjects.
Sign: This collaborator can be assigned as eConsent signee to subjects. The collaborator can sign the consent document via YouSign.

3. Step 3 - Managing eConsent forms in Step 3

All users with the 'eConsent - View' management right will have access to the 'eConsent Forms' tab in Step 3. This tab provides an overview of the uploaded eConsent form(s) per study. As mentioned above, our Customer Success Team will assist you in uploading and configuring the forms provided. 

Here you can see the available eConsent forms for this study, including

• the name of the consent form (which will be visible to site staff and subjects)
• the status of the forms (active or inactive)
• the site(s) assigned to this form
• an optional description
• the timestamps of when the form was created/uploaded and when it was last updated

It is possible to upload multiple active eConsent forms to your study. This allows you to cover multiple use cases, including multicenter studies (one form per study) or multilingual studies (one form per language).

What's more, if there is an amendment to the eConsent form, you can simply upload the new, updated form to start the subject re-consent process.

Hybrid consent

If you have a hybrid study set-up where both paper-based and eConsents will be signed, you can enable this function yourself in the settings under "Step 1 - General". This means upon enrolled of a subject the site has the option to select whether a paper-based consent or an eConsent is suitable for this subject.