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NOTE: This article should only be used to modify your E-Consent survey in Production in order to apply version updates as necessary. If you are looking to create a e-consent survey for the first time, see: E-Consent Initial Setup |
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There are two ways to implement new versions of e-consent:
Creation of new instruments
Branching Logic
Expand the process you wish to review below
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The Process
Updating E-Consent using new instrument creation:
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Modifying the e-consent via new instrument: Since your project is in Production, you’ll need navigate to your online designer and enter Draft Mode Copy your existing E-consent form to quickly copy over the bulk of your E-Consent Move the E-consent (version 2) instrument under the now expired (version 1) instrument Apply needed updates to new version (2) such as… Upload IRB stamp with new expiration date Apply any consent field/verbiage updates required All Consent component should be included in your new version
Submit your drafted changes for review to a REDCap Administrator STOP HERE UNTIL YOUR CHANGE REQUEST HAS BEEN APPROVED
Once the requested changes have been implemented…approved… Enable E-Consent Version 2 as a survey Open E-Consent Version 2 survey settings to perform the below: Update the copied Survey Title: This is what will appear at the top of the participants survey page, edit as needed. Note, the survey title (red) and the instrument name (blue) can be different.
Setup the E-consent Framework Update version number from 1 > 2 (you do not have to use the number 2, but the value listed MUST be different from the first version). Best practice would include version number and IRB expiration date.
CRITICAL STEP: in addition to updating the version number, you also must ensure the framework is pulling data from the new fields in the new consent version (2) for the below inputs: First name (v2) Last Name (v2) DOB (v2) Signature (v2)
Adjust your operational processes or survey settings to send the new e-consent to the participant & retire the old
Next you need to ensure all appopriate user(s) in the project now have access to view the new form. By default when a new form is added, it defaults to ‘NO ACCESS’ to all users as a safeguard, to ensure you are able to update the framework settings as shown above BEFORE collecting new data. Update user rights to access the new form Adjust any operational settings you project may use such as survey queues, ASI’s or form display logic to use the new form. Deactivate the OLD consent:
The survey itself can be switched from active > ‘Survey Offline’ in survey settings, which ensures respondents will not be able to take the survey, even if mistakenly triggered! Image RemovedImage Added |
Updating E-Consent using Branching Logic:
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Additional Considerations
Q. What is the optimal way to handle multiple signatures? For instance, the parent or participant consents and then our PI would need to sign the consent. Usually this is all done in person, however, with e-Consent what is the best workflow?
A. Use a two-part system.
E-consent Survey: consent is signed, reviewed, and submitted within the e-consent framework.
Documentation of Informed Consent /Attestation data form (for staff) can have the participant's information piped in and includes a date & signature field for the PI.