Content Comparison

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Initial Considerations

When a new version of the consent is needed, it is critical to modify the project in such a way as to not lose existing data nor compromise the audit trail of the REDCap e-Consent.

When you have multiple, separate, consent survey(s) in your project, each survey instrument will have it’s own unique set-up options as shown below for an ICF & Assent and Parental Permission Surveys.There are two ways to implement new versions of

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How to version and update e-consent document:

1. Creation of new instruments

2. Branching Logic

Expand the process you wish to review below

The Process

Updating E-Consent using Branching Logic:

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using branching logic:

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Keep the existing public survey instrument as the first instrument in the project

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Create new fields for each updated section of the consent.

1. Updated fields should sit directly under the original field

Create a field in the public survey to denote Consent Version.

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Use Action tags to ensure that only the current version of the e-consent is selected.

Use the @Default to ensure only the most current version is presented and @HIDDEN SURVEY)

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Use of branching logic makes the new fields visible only when the appropriate current version of the e-consent is selected.

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Open survey settings to preform the below updates:

1. 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 approval date.

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2. Below is an example of the issue that occurs if you do NOT update your version number:

   1. participant #3 actually filled out Version 2 but because the survey settings were not updated, the accurate version is not shown in the PDF file display. (However if you open the PDF it will be second version signed by the participant)
       

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After saving your survey settings, the next participant consented will accurately reflect consent version

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Updating E-Consent using new instrument creation:

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Modifying the e-consent via new instrument:

1. Since your project is in Production, you’ll need navigate to your online designer and enter Draft Mode

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2. Copy your existing E-consent form to quickly copy over the bulk of your E-Consent

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3. Move the E-consent (version 2) instrument under the now expired (version 1) instrument

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4. Apply needed updates to new version (2) such as…

   1. Upload IRB stamp with new expiration date

   2. Apply any consent field/verbiage updates required

   3. All Consent component should be included in your new version

5. Submit your drafted changes for review to a REDCap Administrator

6. STOP HERE UNTIL YOUR CHANGE REQUEST HAS BEEN APPROVED

7. Once the requested changes have been implemented…

   1. Enable E-Consent Version 2 as a survey

8. Open E-Consent Version 2 survey settings to perform the below:

   1. Update Survey Title:

      1. This is what will appear at the top of the participants survey page. Note, the survey title (red) and the instrument name (blue) can be different.

         View file
         name Invalid file id - 10613d31-7999-4698-afcb-2ed43e3a458d

   2. Setup the E-consent Framework

      1. 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 approval date.

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   3. 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:

      1. First name (v2)

      2. Last Name (v2)

      3. DOB (v2)

      4. Signature (v2)

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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:

1. 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.

2. Hide the instrument using Form Display logic or by making the survey ASI ‘Not Active’.

3. 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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E-consent Survey: consent is signed, reviewed, and submitted within the e-consent framework.

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1. Navigate to the ‘online designer’ page

2. Rename your instrument to include the updated expiration date.

   1. To do so enter ‘draft mode' > ‘rename’ instrument > then 'submit changes for review’

   2. If your title doesn’t include an expiration date, we suggest adding it as a visual reminder to upload your new version when the time comes.

   3. Review the new version document against the document currently in your project to identify if any additional questions need added into the survey instrument.

      1. Add new fields if applicable

   4. Click ‘Submit Changes for review’

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3. Navigate to e-consent framework feature via the ‘online designer’ page

   1. Click ‘+Add Consent Form’ for the applicable survey

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   2. Input new version number

   3. Choose new PDF file

   4. Verify updated inputs are correct

      1. Make sure the file selected is correct before submitting

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   5. After verifying the desired version and correct file have been input, click ‘Add new consent form’

4. Consent version update is now live and complete!

Old versions of consent forms can be viewed by selecting “View all versions”

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