Create REDCap e-Consent Project

Create Project

1. Log in to https://redcap.wustl.edu/ with WUSTL Key and password.

2. Click +New Project in the top menu

3. Enter Project Title:

4. Purpose of this project: → Research

   1. Add PI name, PI email and IRB number

   2. Check at least 1 area under Please specify:

5. Project creation option: Use a template (choose one below).

6. Select WashU REDCap e-Consent Template Project

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Project Setup

Designate Email Field for Communications

1. Enable optional modules and customizations:

   1. Ensure Designate an email field… has Field currently designated: consent_copy_email or other email field of your choosing

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Remove Record ID from Fully Executed Consent

1. Navigate to Project setup → Click Additional Customizations

   1. Check box next to PDF Customizations

   2. Change the dropdown menus to “Hide it” under Hide Record ID from PDF header? (This will…) and Display or hide the Secondary Unique Field…

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2. Click Save

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Survey Settings

1. Click Online Designer. The Data Collection Instruments table should look like this:

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   1. The instrument names with mmddyyyy will need to be updated following IRB approval

2. Select Survey Settings for Informed Consent Form V1.00 App mmddyyyy.

   1. Basic Survey Options section → Survey Instructions contains example text

   2. Survey Design Options section → choice of default settings or customized

   3. Survey Customizations section: leave on default settings

   4. Survey Access section → Allow ‘Save & Return Later’ option for respondents? is set to: “Yes.”

   5. Survey Termination Options section → Survey Completion Text contains example text

      1. Replace [email] and [phone] with contact information for your study.

   6. Select Save Changes at the bottom of the page

3. Select Survey Settings for Fully Executed Consent Forms V1.00 App mmddyyy.

   1. Basic Survey Options section → Survey Instructions contains example text

   2. Survey Design Options section → you may leave default settings or customize

   3. Survey Customizations section: leave on default settings

   4. Scroll down to the Survey Access section:

   5. Make sure that Allow ‘Save & Return Later’ option for respondents? is set to you “Yes.”
      
      

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   6. Survey Termination Options section → Survey Completion Text contains example text

   7. Click Save Changes

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e-Consent Framework and PDF Snapshot

e-Consent Framework

1. Online Designer → select e-Consent and PDF Snapshots

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2. Click the e-Consent Framework tab

   1. Under e-Consent Framework Settings click the pencil icon under Edit settings next to the "Informed Consent Form V1.00 App mmddyyyy" survey

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3. Screenshot of e-Consent Framework settings:

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4. Written e-Consent Framework settings:

   1. Allow e-Consent responses to be edited by user? → Checked

   2. First name field: → leave as “--select a field --”

   3. Last name field: → leave as “--select a field --”

   4. e-Consent version → 1

   5. Date of birth field: → leave as “-- select a field --"

   6. Signature field #1: → “participant_signature “Signature of Participant”

   7. Save to specified field → Uncheck

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   8. If you leave the Save to specified field box checked, the participant will receive a copy of the consent without the study team signature

   9. Snapshot file name → File name: Remove the “_id[record-name]” from the end of the file name.

      1. File name: [participant_firstname]_[participant_lastname]_pid[project-id]_form[instrument-label]

   10. Click Save settings

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