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

   Open

   

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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

      Open

      

       

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…

2. Click Save

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Survey Settings

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

    

   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.”

   6. Ensure Allow respondents to return and modify completed responses is checked

       

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

   8. 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

    

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

       

3. Screenshot of e-Consent Framework settings:

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

   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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PDF Snapshots of Records

1. Click the PDF Snapshots of Records tab

2. Click +Add new trigger

3. Screenshot of completed Trigger for PDF Snapshot

4. Written Settings for Trigger for PDF Snapshot

5. Name of Trigger: Fully Executed Consent Upload App mmddyyyy

6. Step 1: Trigger conditions

   1. Every time the following survey is completed: → ---select a survey---

   2. Every time the following survey is completed: → Enter logic below:

      1. [participant_signature] <> "" and [participant_name] <> "" and [date_consented] <> "" and [consent_witness_signature] <> "" and [consent_witness_name] <> "" and [consent_witness_date] <> "" and [signed_consent_form_v1] = ""

   3. This logic box does not say whether the logic is valid

7. STEP 2: Scope of the snapshot

   1. Click pencil → select deselect all then check only “Informed Consent Form V1.00 App mmddyyyy” and click Update

   2. Check Save as Compact PDF (includes only fields with saved data)

   3. If using Multi-language Management, check Store the translated version of the PDF

8. Step 3: Location(s) to save the snapshot

   1. Check Save to File Repository

   2. Check Save to a specified field → select “signed_consent_form_v1”

9. STEP 4: Snapshot file name

   1. File name: → remove “_id[record-name]”

      1. File name: pid[project-id]_form[instrument-label]

10. Click Save

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Automated Survey Invitation

Setup ASI to Deliver Fully Executed Consent

1. Go to Online Designer → Automated Invitations next to Fully Executed Consent Forms V1.00 App mmddyyy

2. Screenshot of conditions for Automated Survey Invitations (ASI)

    

3. Step 1: Compose message

   1. From: name participant will see on email

      1. Your name, lab name, study name, etc.

      2. Dropdown contains email addresses of users on project with Survey Distribution Tools user rights

      3. Best to choose wustl email address.

         1. For guest WashU REDCap accounts, see Sending Email Invitations from Guest Wash U REDCap Accounts

   2. Subject: Signed Informed Consent Form for Your Records

   3. Email Body should read:

      In the link below, you will find the fully executed informed consent form for your records, which you may download or come to review at any time.

      You may open the informed consent form for review or download in your web browser by clicking the link below:
      [survey-link]

      If the link above does not work, try copying the link below into your web browser:
      [survey-url]

      This link is unique to you and should not be forwarded to others.

4. Step 2: Conditions → When the following survey is completed → “Informed Consent Form V1.00 App mmddyyyy”

   1. Will include event and arm if longitudinal

   2. Check When the following logic becomes true:

      [consent_copy_distribution] = "1" and [participant_signature] <> "" and [participant_name] <> "" and [date_consented] <> "" and [consent_witness_signature] <> "" and [consent_witness_name] <> "" and [consent_witness_date] <> "" and [signed_consent_form_v1] <> ""

5. Step 3: When to send invitations AFTER conditions are met → Send Immediately

6. Reminders are not needed as the participant can continue using the link in the email to return to the fully executed consent any time.

7. Click Save

8. Click Close on the Settings for automated invitations were successfully saved dialog box

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User Rights

1. Select User Rights from the left-hand menu

2. Click on your username and select Edit user privileges.

   1. Check for the minimum required rights for a study team member to consent which are:

   2. Settings pertaining to project records → Create Records (You may wish to select Rename Records and Delete Records as well)

       

   3. Under Data Viewing Rights, make sure View & Edit is selected for each instrument

   4. Edit survey responses is selected for the Informed Consent Form V1.00 App mmddyyyy under Data Entry Rights

   5. Select Save Changes

   6. Add additional team members: Adding Study Team Members to REDCap Projects

   7. Create Roles for standard sets of User Rights may be helpful if multiple study team members will obtain consent

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Alerts & Notifications

1. In the left-hand menu under Applications, select Alerts & Notifications

2. Check the box next to Show deactivated alerts.

3. Click Options on Alert #1 then Re-enable alert.

    

4. o   Uncheck Show deactivated alerts

5. Click Edit on Alert #1

6. STEP 1: Triggering the Alert

   1. How will this alert be triggered? → When a record is saved on a specific form/survey*

   2. Trigger the alert… → Informed Consent Form V1.00 App mm/dd/yyyy is saved with Complete status only

7. STEP 2: Set the Alert Schedule

   1. When to send the alert → Send Immediately

   2. Send it how many time? → Just Once

8. STEP 3: Message Settings

   1. Email From: your name, lab name, study name, etc. in the text box and email address you would like the email to be delivered from in the drop-down menu

   2. Email To: [email_attestation] “WUSTL email address of the study team member comple…”

   3. Subject: Informed Consent Form to Review and Sign

   4. Email Body:

A participant has completed an informed consent survey. Please click the Informed Consent Survey link to review their responses.  After reviewing all information in the Informed Consent form, please click the Edit Responses button and complete the consent by:

1. Signing the consent using your mouse

2. Typing your First and Last name

3. Clicking now next to Date and time

4. Click Save & Exit Form.

Click to review Informed Consent: [form-link:informed_consent_form_v100_app_mmddyyyy:Informed Consent]

Thank you!

9. The ‘mmddyyyy’ in the form-link smart variable will need to be updated following IRB approval

10. If the study has multiple arms, specify event name before the form-link variable:

    1. [event_1_arm_2][form-link:informed_consent_form_v100_app_mmddyyyy:Informed Consent]

11. Click Save

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