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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 Branching Logic:
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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… Enable E-Consent Version 2 as a survey
Open E-Consent Version 2 survey settings to preform the below: 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) 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) Signautre (v2)
9. Adjust your operational processes or survey settings to send the new e-consent to the participant & retire the old. How this is done depends on your project operational flow and how surveys are sent to participants. Suggested steps: Limit user access to the original e-consent survey through ‘User settings’, however this will not limit ASI’s/Form display logic. If your project uses either of these functionalities, further steps are required to ensure the old consent is no longer used or triggered. Hide the instrument using Form Display logic or by making the survey ASI ‘Not Active’. The survey itself can be switch from active > ‘Survey Offline’ in survey settings, which ensure respondents will not be able to take the survey, even if mistakenly triggered!
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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? I know the records are locked, so what is the best way to have that signed?
A. Use a two-part system.anchor
_GoBack | _GoBack | E-consent Survey: consent is signesigned, reviewed, and submitted within the e-consent framework.
Data entry Attestation form (for staff):form which can have the participant's information piped in and includes a date & signature field for the PI.