Author: Audrey Perdew

Introduction

As of February 2025, RDCRN REDCap will be updated to a version that includes the new Enhanced eConsent Framework, commonly referred to as eConsent 2.0. This article provides guidance on how to transition existing REDCap projects from eConsent 1.0 to 2.0. Major differences include:

• eConsent framework configuration has moved out of Survey Settings to a specific eConsent and PDF Snapshots feature available through the Designer.

• During the setup process for consent forms, their location can be set in relation to a single descriptive field on the survey.

• A consent form can be associated with a specific language and/or a Data Access Group.

• Improved version control for easily managing new versions of consent forms while maintaining historical versions for audit purposes.

• PDF Snapshots that can combine multiple forms and/or signatures into a single PDF document.

Important notes about the installation of these new features:

• No immediate changes are needed. Existing eConsent projects will migrate necessary settings automatically with no interruptions to eConsenting.

• eConsent 2.0 enhancements will be apparent during project setup the next time a new version of a consent document is implemented or you choose to transition to take advantage of the new features.

• The participant experience will be unaffected upon initial installation of eConsent 2.0. Transitioning your project to eConsent 2.0 will not significantly impact patient experience but may include minor changes in the look and feel of the elCFs.

Migrate to New Instruments 

Each consent document will have its own unique instrument. This REDCap instrument will be used for all versions of its corresponding paper form moving forward.

Create New Instrument

1. Copy the existing instrument that requires a new version 

• Find the instrument that requires a new version in the Designer

• Click Choose action and Copy 

  • Update the instrument’s name – do not specify a version in the instrument name

  • Verify addendum of your choice to variable names (ex: “_v2”) 

  • Click Copy Instrument

    2. The new copy will appear at the bottom of the instrument list. Move the new copy underneath the old instrument. 

Update New Instrument

1. Click on the new instrument to open it.  

2. Delete the blank PDF file download field. Downloads will be automatically available in the new framework. 

3. Delete all fields that display consent inline images. Make sure to keep all fields that require participant responses (i.e. signatures, multiple choice questions, etc.)

4. Create a new, empty descriptive text field where you want the consent form to be. This will be used later to display the new consent form.   

5. Create a new text field that will automatically capture the REDCap consent version

   1. Add @CONSENT-VERSION @HIDDEN-SURVEY @HIDDEN-PDF action tags to the field

6. Add versioned branching logic to fields requiring participant response

7. Review all other branching logic on new instrument 

   1. Ex: Branching logic that participants can only provide a signature after selecting they would like to participate 

8. Rename former instrument and survey title

Repeat Steps 1-10 for each instrument

Updating “Individual Obtaining Consent” Instrument  

1. Open the “Individual Obtaining Consent” form in the Designer

2. Click the green arrow, branching logic icon on the staff name or signature field 

3. Keep the existing logic, and add a condition for the corresponding new consent instrument being complete

Repeat for each staff name and signature field 

Review and Submit Changes  

1. Review changes (located under Designer, on the top left of the webpage ) 

2. Click View detailed summary of all drafted changes and verify that you have made all appropriate additions 

3. Review Details regarding all changes made in Draft Mode:. You should see the appropriate number of Fields to be added: and Total potentially critical issues: should equal 0.  

   1. If there are potentially critical issues indicated in red, you must correct them before all changes are moved to production  

      

   2. Example of potential critical issue – deleting an existing field or renaming answer choices that will result in data loss  

   3. A detailed breakdown of all changes is available in the Below is a listing of the changes to be committed to this project. table 

   4. If you submit changes with at least one critical issue, the RDCRN REDCap admin will ask you to confirm this is what you want 

4. Click Return to Previous Page and Submit Changes for Review 

5. Click Submit – changes will be automatically implemented if done correctly

NOTE: The new instruments are now in production. They are not fully functional and cannot be used by participants until the rest of the following sections are also competed.  

Survey Settings

1. Click Survey settings located to the right of the new instrument’s name in the Designer 

2. Confirm Survey Status is set to Survey Active 

3. Change Survey Title if applicable 

4. Confirm general survey settings of the former instrument copied to the new instrument 

5. Send Confirmation Email 

   1. Confirm that Send confirmation email? is set to Yes 

   2. Confirm the Include PDF of completed survey as attachment box is checked 

   3. Confirm or update the email message with the IRB approved message 

6. Verify that the other settings are appropriately configured  

7. Save all Survey Settings

Repeat for each new instrument

Make New Instrument(s) Accessible

The new instruments must be in production for this step. If they are not, go back to Review and Submit Changes

User Rights for New Instrument(s)

1. Update User Rights to have access to the new instrument

2. Select Read Only radio button for new consent instrument under the Data Entry Rights on the right-hand side 

3. Confirm the Edit survey responses box is unchecked 

Repeat for each role 

Designate Instruments to Events

1. Click Project Setup 

2. Click Designate Instruments for My Events

1. Click Begin Editing 

2. Select the new instrument(s) for all events 

3. Click Save 

Update Survey Queue

Located in the Designer in the grey box above the instrument list 

1. Export the current Survey Queue and save as part of change management documentation 

2. Click Survey Queue 

3. Click Activate next to new instrument(s)  

4. Set up the survey queue logic for the new instrument(s) 

   1. Select appropriate instrument from drop down menu. Pay special attention to select the correct instrument version from the correct event (e.g. Consent, Re-consent 1, PRN Consent 1, etc.). 

   2. Copy and paste the survey queue logic of the former instrument to the new instrument. If needed, update logic to reflect new field names. 

   3. Select Auto Start option if being used 

5. Click Deactivate on the former instrument survey queue setting 

6. Verify the logic for any other instruments in that event is still accurate  

Repeat for each new instrument in each event  

1. Click Save 

2. Export updated Survey Queue and save as part of change management documentation 

Configure eConsent Settings

eConsent framework settings are no longer located in Survey Settings. Instead, they are located in the Designer in the grey box above the instrument list 

Update eConsent Framework

1. Click Enable the e-Consent Framework for a survey 

2. Select the new instrument from the dropdown list

3. Complete configuration settings  

   1. Verify that the Allow eConsent responses to be edited by users? checkbox is unchecked

   2. Select first name, last name, and date of birth fields from the Landing Page 

   3. Add IRB approved version # as a Custom tag 

   4. Select all signature field(s) 

   5. Optional: Static PDFs of completed consents will always be saved to the File Repository, but you may also select a field in the project a PDF of the completed instrument 

4. Update any other configurations as desired 

5. Click Save 

Repeat for each new instrument 

Add Consent Form

1. Click Add consent form 

2. Enter consent form version 

3. Select the new descriptive field created during Update New Instrument for placement of the consent form

4. Click Consent Form (Inline PDF) 

5. Upload the new consent document. The file must be a PDF. 

6. Click Add new consent form 

Repeat for each new instrument 

Wrapping Up

Retire Former Instrument(s)

1. Click on Survey Settings of the former, now inactive instrument

2. Set Survey Status to Survey Offline 

3. Click Save Changes

 Repeat for each inactive instrument 

1. Optional: Organize the retired instrument(s) 

   1. Enter Draft Mode

   2. Drag and drop the instrument(s) to your desired placement on the instrument list 

   3. Repeat steps above to Review and Submit Changes 

Testing

1. Site users and the study eConsent management team members should test the functionality and verify the updated verbiage and logic 

2. Run a few test records through the updated workflow.   

   1. Test records will appear as real records. Use an obvious and unique naming convention for the Local ID (e.g. TEST-001) so these records can be easily identified 

   2. When doing test data entry, enter study staff information or obvious fake information (i.e. Participant’s name: First-test Last-test) to emphasize again that these are test records 

   3. Test records should not be deleted from the eConsent project. They are useful to have and keep as documentation of testing