Sending Completed eConsent Forms using REDCap
Email is not considered a secure means of communication and should not be used when sending identifying information.
Completed eConsent forms should never be sent as email attachments
Both methods outlined below transmit files using an encrypted connection (HTTPS/TLS)
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.
If you do not have a @ucalgary.ca email address, your email may not be received by the participant. Learn why here.
Using Survey Login & PDF Snapshot
With some setup, completed eConsent forms can be sent automatically (or upon a manual trigger).
Setup Steps
Step 1. In the same project as your eConsent, create a new instrument that will be used to send the completed forms.
Step 2. Create fields in the new instrument, as needed:
Login code is a text field meant to contain a password-like code that the participant will need to enter before accessing the download page.
If Survey Login is already used by the project, the same login settings can be used for this form and this field is not needed.
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).
The action tag @HIDDEN-SURVEY is used so that this field is not seen by the participant.
Email is a text field with the “email” validation type.
If participant emails are already used by the project, this field is not needed.
The action tag @HIDDEN-SURVEY is used so that this field is not seen by the participant.
Your completed eConsent form is an upload field that will contain a copy of the participant’s completed form.
The action tag @READONLY-SURVEY prevents the participants from accidentally erasing/overwriting the file stored here.
Send to participant? is a radio field with one option (Send). This field is only needed if the process to send the completed eConsent form is to be semi-automated (the email subject, body, and address to and from are automatically filled in, but the email is not sent until this manual trigger to send is met).
The action tag @HIDDEN-SURVEY is used so that this field is not seen by the participant.
Step 3. Enable Survey Login, if the project does not already have it enabled. The Login Code field created earlier can be used as the login field.
For the purposes of sending the completed eConsent form, for “Apply the survey login to all surveys in project?“ ensure that “Only selected surveys…” is selected. Otherwise, the login code will be asked on every survey in the project.
Save the Survey Login settings.
Step 4. Enable the new instrument as a survey. Customize the survey settings as desired, but ensure “Show or hide the Submit buttons” is set to “Always hide…”.
By hiding the submit button, the participant will only be able to download their form and exit the page.
Ensure that this survey required a login code by setting “Enforce ‘Survey Login’?” to “Yes”. This field is not present if Survey Login is set to “All surveys”
Save the Survey settings.
Step 5. Setup the PDF Snapshot to automatically save the completed eConsent form to the upload field created earlier.
If the form is complete the moment the participant has submitted it (no countersignature required), the e-Consent settings can be altered to include this step.
In the e-Consent Framework Settings click the “Edit settings” icon for your eConsent form. Under the “Location(s) to save the signed consent snapshot” select the option to “Save to specified field” and select the upload field created earlier.
Save your e-Consent Settings.
If the form is complete at some point after the participant has submitted it, you can use PDF Snapshots to create a custom trigger upon the form’s completion.
For example, if the eConsent form is split into 2 instruments due to requiring a countersignature by a member of the study team, the trigger could be the completion of the second part of the eConsent form while the scope would include both instruments.
Under the “Location(s) to save the snapshot” select the option to “Save to specified field” and select the upload field created earlier.
Step 6. If desired, automate sending the link to the completed eConsent form using ASIs.
This requires that your project has a Designated Email Field set (on the Project Setup page)
In the Online Designer, create an Automated Invitation for the new instrument
Ensure you are sending FROM an @ucalgary.ca email address. Learn why here.
In the section “STEP 2: Conditions”, use the desired trigger for sending this to the participant.
To send immediately after the eConsent form is uploaded, adapt the following logic to your project’s variable names. This logic ensures that all the necessary pieces of information are entered before sending.
[email] <> "" and [login_code] <> "" and [form_upload] <> ""To send automatically after a manual trigger, the “Send to participant?” field created earlier can be used (it was given the variable name send_form). Adapt the following logic to your project’s variable names. This logic ensures that all the necessary pieces of information are entered before sending, and that the manual trigger is met.
[email] <> "" and [login_code] <> "" and [form_upload] <> "" and [send_form] = 1
Sending the completed eConsent form
A login code and participant email are required. If both were created using the steps above, they are on the instrument used to send the completed eConsent form.
The participant needs to know what their login code is to access the page. The code can be sent in a separate email, given verbally, or the code could be set as something that the participant already knows.
The ability to create randomly-generated login codes requires a REDCap administrator. Contact us if you would like to automate login code creation.
When the eConsent form is completed, it will be uploaded automatically to the form. If the ASI is set to send the form immediately, there are no other steps required.
If using a manual trigger for the ASI, return to the form after the eConsent has been completed and trigger it. The Form Status can be used to indicate whether all steps by the study team are complete.
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 the 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 hidden fields (email, login code, manual trigger field) do not show if the @HIDDEN-SURVEY action tag was used. The participant cannot ‘submit’ the form, so they can continue returning to the survey page and downloading the form as long as they have the survey url and know their login code. The survey url can also be re-sent to the participant as needed.
Additional security options
Use Survey Options, “Time Limit for Survey Completion” to restrict the amount of time that the eConsent download is available (i.e., the participant has 7 days to download the form before the link automatically expires).
Use the Action Tag @DOWNLOAD-COUNT to restrict the number of times that the completed eConsent form can be downloaded. Combined with branching logic, the download field can be removed from view when the download count is greater than 0 and ‘replaced’ instead with a descriptive field informing the participant to contact the study team if they require another copy.
The “Receive confirmation” feature from Send-It can also be re-created in your REDCap project using the Action Tag @DOWNLOAD-COUNT to trigger an email using Alerts & Notifications.