Sending Completed eConsent Forms using REDCap

Email is not considered a secure means of communication and should not be used when sending identifying information.

Using REDCap’s Send-It feature

Send-It is a tool in REDCap that is accessible from REDCap’s menu header.

How it works

Rather than attach the form to the email, the Send-It tool sends a pair of emails to the participant: one with a unique download URL and one with a password. The participant is instructed to follow the URL and enter the password, taking them to a place where their form can be downloaded.

 

Limitations

  • the Send-It feature is not linked to any one REDCap project and requires the participant’s email address to be copied in manually.

  • The eConsent form has to be carefully matched to the participant to ensure the correct form is being sent to the correct person.

  • Both emails are being sent to the same email address simultaneously. While more secure than an attachment, this method does not protect the participant’s information if the participant’s email login is compromised or shared.

 

Using the CRU’s eConsent framework

The CRU’s eConsent Tool contains a template survey instrument that allows the participant to access and download the completed form.

Template setup

This method requires REDCap’s Survey Login to be enabled.

In the CRU eConsent Framework, the default setting for Login field #1 is send_login_code

To enable Survey Login on only the ‘Send Completed Forms’ instrument, ensure ‘Apply the survey login to all surveys in project?’ is set to ‘Only selected surveys’

In the Survey Settings for the 'Send Completed Forms' instrument, enforce survey login.

Auto-uploading the eConsent form

To auto-upload a completed consent form into the upload field, go to the Survey Settings for the eConsent form. Set the option to ‘Save a PDF of completed survey response to a File Upload field’

 

Using the Template

In the record for the participant, the form requires three pieces of information before the consent form can be sent to the participant:

Completed Consent Form

This upload field contains the form that will be available for download by the participant.

If the eConsent form has been split into multiple parts due to the need for countersigning, the individual PDFs can be downloaded and merged before being uploaded into this tool manually.

 

Login code

In the template, this field is controlled by the study team. The code entered into this field will be used by the participant to access the download page. If Survey Login is already used by the project, the same login settings can be used for this form.

The study team can inform the participant of their login code via email, phone, or other means. Using REDCap’s Survey Login settings, the code can be set to another field in the project (i.e., date of birth).

 

Participant’s email

By default, the template expects a field named participant_email to exist and be set as the designated email field. This can be customized to your project. Learn more here.

 

Send to the participant

Once the information is entered, the page can be sent. By default, the template uses REDCap’s Automated Survey Invitations.

The participant can receive the link to the download page using the same methods used to send a REDCap Survey (Compose Survey Invitation, Automated Survey Invitations, Survey Access Code, QR code, etc.)

 

 

How the participant accesses their forms

After receiving their survey invitation, the participant is directed to a Survey Login page where they will need to enter their login code.

 

After successfully logging in, the download page appears. The participant can click the link to download the PDF of their completed form.

The template tool hides the ‘Submit’ button from the survey page, as the participant is not asked to submit any information.

If needed, the study team can send a new survey invitation for the participant to access the form again at a later date.

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