Checklist: Does my eConsent form meet best practice requirements?

• Surveys are enabled in my project. The eConsent form is enabled as a survey

• In the ‘e-Consent Framework Settings' the eConsent form is setup and active, and version control is being used

• The contents of my eConsent form are accurate to the consent form approved for use in my study

• A signature or other field has been added to my eConsent form, and only the appropriate person uses this field

• The eConsent form is only being filled out as a survey, not within REDCap

• The completed consent forms are obtained from the PDF Survey Archive in the File Repository

• If the Survey Setting option to ‘Send confirmation email’ is being used, the option to Include PDF of completed survey as attachment is not enabled

• Consent forms are not being emailed

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To help ensure that only the participant is using the signature (or other) fields, they can be marked with the action tag @READONLY-FORM. This will make the field ‘greyed-out’ in REDCap while still being accessible in the survey view.

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REDCap’s Snapshot module creates a PDF copy of the eConsent form when it us submitted. This is important for versioning purposes, as the consent form instrument may be modified in REDCap after the participant submits the form. This is also important in case the form is edited by a member of the study team after it is submitted.

Why would a member of my study team modify a completed consent form?

There is an option in the Settings page that allows eConsent forms to be edited after submission. Forms created in older versions of REDCap may have this enabled by default, or it may have been enabled to allow for countersignatures (i.e., study personnel) to be added after the participant submitted the form.

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REDCap’s Snapshot module only captures the form when it is submitted as a survey. Thus, eConsent forms must be completed as surveys. Using the @READONLY-FORM action tag helps enforce this by making it impossible to complete an eConsent form in REDCap.

As it is possible for the version of the consent form to change after the participant submits it (using the Online Designer), or for the information within in the form to be changed (if survey responses are allowed to be edited by users), it is critical that the static copy captured by the Snapshot module is used. This ensures that the form is accurate in version and information to what the participant signed.

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