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Who should review this material:

  • Personnel building project
  • Personnel managing the project


Topics covered: 



Determine Which Consent Process/Use Case Applies to Your Project 

In order for a project builder to correctly identify the consent process/consent use case that applies to their specific project, the builder needs to have both a general understanding of consent, as well the consent requirements for their particular study. For clarification about the consent requirements for their study, the project builder should consult with their PI, Co-PI or the regulatory specialist on their study team.

To be successful at setting up a project for consent, it's crucial for the project builder to be able to answer the following questions about their study's consent requirements: 1) Is the participant's signature required on the consent form? 2) Does the consent process require documentation of the study staff obtaining consent? 3) Does consenting participants for the study involve any of the criteria listed in the section below, When Additional Help from the REDCap Team is Required.

Once the project builder has identified which process/use case applies to their study, the expectation is for the builder to either download  one of corresponding forms from the REDCap Shared library or upload one of the corresponding form templates stored on this page into the project they're building. The other option is if the builder is requesting a new project, to start their project from one of the corresponding project templates. All templates consist of pre-built forms that the project builder modifies to meet the consent requirements and consent process for their study. 

Effective May 1st, 2021, project builders must utilize one of the REDCap templates, as described above, to not incur charges. There are fees for any help, including help at drop-in, for consent forms built from scratch.

Consent Processes a Project Builder can Set up via the Supported Self-Service Model

(tick) Agreement to Participate (Information Sheet) - No Signature

  • Replaces paper Information Sheet.

  • Participant signature is not required.

    • IRB has waived the requirement for a written signature on the consent and granted a waiver of the signature requirement on the HIPAA authorization.

  • Allowable for minimal risk studies.

(tick) (plus) Agreement to Participate (Information Sheet and Authorization) - With Participant Signature

  • (warning) Participant signature(s) is required.

  • Documentation of study team confirming consent is not required.

  • Used typically when there is not a live consenting session.

(tick) (plus) (plus) Agreement to Participate (Consent and Authorization ) - With Participant Signature and Live Consent Process

  • Replaces paper full consent form.

  • (warning) Participant signature is required.

  • Can be used for real-time consenting - either live or remote consent discussion.

  • The consent process requires documenting the study personnel who obtained consent.

  • For remote consenting, the consent process includes a virtual consent session, via phone or video conferencing, for study staff to explain the study to the participant and answer their questions

  • Suitable for above minimal risk studies.


When Additional Help from REDCap Team is Required

Additional help from the REDCap Team will be needed to set up a REDCap project for consents and/or consent processes that involve any of the following:

  • Consenting persons under age 18
  • Accommodating an LAR
  • Using a translator
  • Distributing the consent in multiple languages
  • Re-consenting
  • Adding consent to a project in production

If any of the above apply to your project, contact the REDCap Team at redcap@ohsu.edu to initiate the process of gathering requirements to create an estimate for charges for the additional help.


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Review How the Consent Process is Implemented with Real Subjects

It's essential that the personnel building and managing the project understand the activities that will be involved in the implementation of the consent process with real subjects. They  will need to consider the workflow that pertains to their study's consent process as they plan for 1) testing the project, 2) training the study team on using the project for consenting, and 3) documenting consent operations. 

Consent Processes and their Corresponding Workflows for Obtaining Consent


(tick) Agreement to Participate

(tick) (plus) Agreement to Participate + Participant Signature

(tick) (plus) (plus) Agreement to Participate + Participant Signature + Live Consent Process

Also referred to asInformation SheetInformation Sheet and AuthorizationConsent and Authorization
Signature Requirement
  • Waiver of signature
  • Waiver of signature on HIPAA authorization (if PHI involved)
(warning) Participant signature required
  • (warning) Participant signature required
  • Signature of person obtaining consent required
  • Live virtual or in-person consent process
Consent Workflow
  1. Consent survey link distributed to potential participant.

  2. On their own, participant completes and submits consent survey.

  3. Once the survey is submitted, a participant can download a PDF copy of their completed consent survey.

  1. Consent survey link distributed to potential participant.

  2. Participant completes consent survey, verifies the information entered in the survey is correct and then submits the survey.

  3. Once the survey is submitted, participant downloads a PDF copy of their completed consent survey.

  4. The system automatically saves the PDF copy of the completed survey in project’s file repository.

  1. Consent survey link distributed to potential participant.

  2. During a consent session with the study staff, either held in-person or virtually, participant completes consent survey, verifies the information entered in the survey is correct and then submits the survey (e.g. Live consent process).

  3. Once the survey is submitted, participant can download a PDF copy of their completed consent survey.

  4. The system automatically saves the PDF copy of the completed survey in project’s file repository.

  5. Study staff who obtained consent completes a consent attestation survey, verifies the accuracy of the information entered, and then submits the survey.

  6. If necessary, study staff download a PDF copy of the staff completed attestation to send to the participant.

  7. The system automatically saves the PDF copy of the completed survey in project’s file repository.


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Step by Step Instructions for Setting Up Your REDCap Project

BEST PRACTICE: Start with the OCTRI Template that corresponds to the consent document submitted to and approved by IRB.

Effective May 1st, 2021, project builders must utilize one of the REDCap templates, as described in the section below, to not incur charges. Fees are associated with any help, including help at drop-in, for consent forms built from scratch.


Form Template ZipForm Template REDCap Instrument LibraryProject Template
When to use each template type

Add a template to an already existing project: 

  • You've already started building your REDDCap project.
  • Your project is in Development.

Add a template to an already existing project: 

  • You've already started building your REDDCap project.
  • Your project is in Development.

Start a new project from a template:

  • You haven't already requested a project.
  • There is not an existing project for the study you've started building.
Agreement to Participate (participant signature NOT required)

Information Sheet zip


Download template from the Instrument Library: OHSU Information Sheet Template (participant signature waived)C. OCTRI Consent Template - Information Sheet Only
Agreement to Participate + (warning) Participant signature required

Information Sheet and HIPAA Authorization zip


Download template from the Instrument Library: OHSU Information Sheet And Authorization Template (participant signature required)D. OCTRI Consent Template - Information Sheet with Required Signature
Agreement to Participate + (warning) Participant signature required + Study staff signature required + Live virtual or in-person consent process

Consent and Authorization zip

Study Staff-Consent Attestation zip


Download templates from the Instrument Library:

  • OHSU Clinical Research Consent Template (participant & study staff signatures required)
  • OHSU Study Staff - Consent Attestation Template
E. OCTRI Consent Template - Consent and Authorization
Instructions for Using Template
  • Do not open zip.
  • Upload zip into your project via Online Designer > Upload button.
  • Follow instructions on this page and in the template to:
    • Edit the consent form to match your study's consent document.
    • Enable the form(s) to be a survey(s).
  • Follow instructions on this page and in the template to:
    • Edit the consent form to match your study's consent document.
    • Enable the form(s) to be a survey(s).
  • Click on the New Project tab.
  • Fill out the Create a new Project form.

  • At the end of the form, for the option, Start project from scratch of begin with a template? 
    • Select the appropriate template from the Choose a project template table. 
  • Click Send Request button.

Step 1: Modify / Build the Consent Form

Modify a Template (NO CHARGES)

Build From Scratch (CHARGES STARTING AT $100)

  • If your are using a form template, upload the zip file.
  • If you started your project from one of content project templates, the consent form is included in your project.
  • Click on the consent form to edit it.
  • Create a form for your consent document.
  • Click on the form to edit it.

1A - Form Field for Versioning 

(tick) Edit the Version radio button field as follows:

  • Edit the option 1, Version 1.0 to correspond to the version of your consent form.
  • A version can be either a date or a number (refer to Figure 1-T) or a combination of both, .i.e 1, V1-01.20.2021 

Figure 1-T: radio button for versioning - Online Designer View

(plus) At the top of the form, add a radio button field to capture the consent form version, with a single option that corresponds to the version number of the consent form you are building.

  • A version can be either a date or a number or a combination of both.
  • Neither the study staff nor the participant will enter data in this field and the field will be hidden from the subject.
  • Apply the following Action Tags to this version field: 
    • @DEFAULT to set the field value when to the current version. Example:@DEFAULT = "1"

    • @HIDDEN-SURVEY to hide the field when the subject views the consent form as a survey.
    • @HIDDEN-PDF to hide the field from being included in PDF copy/download.
    • @READONLY to disable data entry on the filed

Figure 1-S: Adding the radio button for versioning


Figure 2-S: radio button for versioning - Online Designer view

1B - Form Field for Approval and Expiration Dates

(tick) Edit the ICF approval and expiration dates descriptive text field as follows:

  • For IRB Approved: replace MM-DD-YYYY with the date of your consent form's approval.
  • For Approval Expires: replace MM-DD-YYYY with the date of your consent form's expiration.

Figure 2-T: descriptive text field for dates - Online Designer view

(plus) Add a Descriptive Text field for the approval and expiration dates of your consent form.

  • Add the approval and expiration dates on separate lines as follows:
    • IRB Approved: MM-DD-YYYY (where MM-DD-YYYY is the date of approval for your consent form).
    • Approval Expires: MM-DD-YYYY (where MM-DD-YYYY is the date your consent form expires).
  • Use the Rich Text Editor to unbold the dates.
  • Set the text to Align Right

Figure 3-S: Adding the descriptive text field for the approval and expiration dates

(info) Edits are NOT needed to the descriptive text field for the logo.

(plus) Add a Descriptive Text field for OHSU logo.

  • Download the OHSU logo (ohsu_logo_transparent.png) to your local machine. 
  • Do not enter a Field Label.
  • For Attach an image, file, or embedded audio setting, click Upload file.
    • Upload the OHSU logo (ohsu_logo_transparent.png) you downloaded to your machine.
  • For Display format of attachment on page setting, select Inline.

Figure 4-S: Adding the descriptive text field for the OHSU logo

Figure 5-S: descriptive text field OHSU logo - Online Designer view

1D - Form Fields for Text of the Consent Document

(tick) Modify the multiple placeholder Descriptive Text fields to add the text/content of your consent document to the consent form.

Each template contains multiple placeholder Descriptive Text fields that are based on and consistent with the discrete sections laid out in the corresponding OHSU IRB approved consent Word template.

  • Copy and paste each discrete section of your consent document into the matching Descriptive Text field. 
  • Use the rich text editor for formatting.
  • Transform any special formatting from the Word document into HTML, such as bulleted lists and tables.
  • Remove any Descriptive Text fields that are not pertinent to your consent document.

Figure 3-T: Example of place holder descriptive text fields - Online Designer view

(plus) Create a Descriptive Text field for each discrete section of your consent form.

  • Copy and paste each discrete section of your consent document into its own Descriptive Text field.
  • Use the rich text editor for formatting.
  • Transform any special formatting from the Word document into HTML, such as bulleted lists and tables.

Separating out each section of the consent document into individual fields is recommended to make the form easier to edit and maintain over time and to help manage versions. Making revisions to the consent form is reviewed later in these instructions.

Figure 6-S: Adding a descriptive text field to add a content from the consent document to the consent form

Figure 7-S: Example of individual descriptive text fields with content from the consent document - Online Designer view

1E - Form Field for Agreement to Participate

(tick) Edit the Consent radio button as needed to describe your process for collecting the subject's consent decision. 

  • Modify the language as needed to describe your process for collecting the subject's consent decision.

Each template contains a placeholder Consent(icf_consent) radio button field for capturing the subjects consent decision.

Figure 4-T: Example of placeholder radio button for consent - Online Designer view

(plus) Add a radio button field radio button field with two options (an option to consent and an option to NOT consent) document the subject’s consent decision.  

  • Make this field required.
  • Modify the language as needed to describe your process for collecting the subject's consent decision.
  • (warning) If a the subject's signature is required on the consent document, set up a Stop Action for the option you created for to capture a subject NOT participating, i.e. NO consent.

In Figure 8-S and Figure 9-S, we created the options 1, Yes, I agree to participate and 0, No, I do not wish to participate for capture the subject's consent decision.

Figure 8-S: Adding a radio button field to capture the subject's consent decision 

Figure 9-S: Example of the radio button for consent - Online Designer view

(warning) 1F - Form Fields for Capturing a Subject's Signature (only if subject's signature is required)

(info) The subject signs the e-consent form by entering their first name and last name into text fields, instead of adding an electronic signature.

(tick) Optionally, edit the field labels of the First name and Last name text fields  to meet your consent requirements.

In Figure 5-T we edited the First name field label to display Participant first name.

Figure 5-T: Example text fields for subject's first and last names – Online Designer view

(tick) Add text fields for the subject to enter their first and last name. In the e-consent form the subject types in their first name and last name instead of adding an electronic signature.

  • Add a text field for the subject's first name

    • Make this field required.

    • Apply branching logic to only show the field if the subject agrees to participate in the study, i.e.[icf_consent] = "1"

  • Add a text field for the subject's last name

    • Make this field required.

    • Apply branching logic to only show the field if the subject agrees to participate in the study, i.e. [icf_consent] = "1"

Figure 10-S: Adding a text field for the subject's first name

Figure 11-S: Example of text fields for subject's first and last name - Online Designer view

(minus) NO Form Field Needed for Capturing Date of Consent

  • The timestamp that's captured by REDCap when the consent survey form is submitted is considered to be the date of consent.
  • The timestamp is added to the footer of the PDF copy of the subject's completed consent form.

  • The timestamp can be added to a report or export.

  • There are 2 smart variables that reference the timestamp and can be used in branching logic, piping, automated survey invitations, etc.
    • Date: [survey-date-completed:instrument]
    • Date and Time: [survey-time-completed:instrument]

(info) Consent Form Examples - Online Designer View

Consent Form / Information Sheet (no subject signature)




Consent Form / Information Sheet (warning)(subject signature required)



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Step 2: Enable the Consent Form to be a Survey

There are more than 20 elements that can be defined in the Survey Settings. We cover a subset of those elements in our instructions, focusing on what's required to support consent and what's related to best practices, as well as highlighting the key decision points associated with consenting online.

If you started your project from one of the Project Templates, the consent form has already been enabled as a survey and only a few modifications will be required. However, you should still review the settings outlined below so you can support the consent process for the project.

Survey Settings

2A - Basic Options

  • Edit the Survey Title to be unique.
    • We recommend using the study's short title + Agreement to Participate

  • Edit the Survey Instructions to include the contact information for the study team.
    • Additional instructions can help the subject understand how to interact with the consent survey AND this messaging will require IRB approval.

Figure S-1: Survey title and instructions - Survey Settings view

2B - Survey Design Options
  • Do not upload any image for the Logo.

    • The OHSU logo should be added to the form itself, as described in STEP 1.

    • If your paper consent form has a barcode, do not upload the barcode image.

    • A file uploaded as a logo is not included in the downloadable PDF copy. 

  • Accept the default setting Standard radios and checkboxes for the setting: Use enhanced radio buttons and checkboxes? unless you anticipate the majority of subjects will be completing the consent survey on phone or tablet, in which case you select Enhance radios and checkboxes.

Figure S-2: Standard radios and checkboxes - Survey Settings view

2C - Survey Customizations
  • (warning) If the subject signature is required on the consent form, select Yes for the setting: Allow participants to download a PDF of their responses at end of survey?
  • Accept the default selection, Yes, for the setting: For 'Required' fields, display the red 'must provide value' text on the survey page?

Figure S-3: PDF downloads and display must provide value for required fields - Survey Settings view

2D - Survey Access
  • Do not enable Save and Return.

    • Subjects should be instructed to only start entering their information in the consent survey when they are ready to complete it.

Figure S-4: Save and Return disabled - Survey Settings view


2E - Survey Termination Options
  • DO NOT check the box to enable Auto-continue to next survey.

  • Edit the Survey Completion Text to include the contact information for the study team.
    • Additional instructions can help set expectations for the subject AND this messaging will require IRB approval.

Figure S-5: Auto-continue disabled and completion text - Survey Settings view

2F - e-Consent Framework and PDF Auto Archiver
  • For consent surveys that do not need the subjects signature select Auto-Archiver enabled.
  • (warning) If the subject signature is required on the consent form, select Auto-Archiver + e-Consent Framework.

Figure S-6: Auto-Archiver enabled - Survey Settings view

2G - (warning) e-Consent Framework Options (subject signature required)
  • DO NOT check the box Allow e-Consent responses to be edited by users?
    • Instead follow the study's approved procedure for consent withdrawal.

    • Editing a subject's completed consent form that has the e-consent framework set up for it would invalidate a participant’s consent.
  • Enter your e-Consent version.

    • The version is included in the footer of PDF copy of the completed consent survey.

  • For the First name field and Last name field, select the fields from the form that capture the subject’s first and last name.

    • The subject's first and last name is included in the footer of PDF copy of the completed consent survey.
  • Any values entered in the Optional fields will be included in the footer of PDF copy of the completed consent survey.
  • Select the following signature settings for Force signature field(s) to be erased if participant clicks Previous Page button while on the certification page?

    • Signature field #1: Select the subject's first name field.

    • Signature field #2: Select subject's last name field.

Figure S-7: e-Consent configured - Survey Settings view

2H - PDF Copy Stored in File Repository
A PDF copy of the submitted consent form is saved to File Repository > PDF Survey Archive.

Figure S-8: PDF copy of subject submitted consent form in the File Repository

(info) Consent Form Enabled as Survey Example(s)

Information Sheet (warning)(subject signature required)

e-Consent Added to End of Information Sheet (warning)(subject signature required)

Information Sheet  - Termination  (warning)(subject signature required)

e-Consent in PDF Footer of Information Sheet (warning)(subject signature required)


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BREAK - Decision Point

(minus) Skip Step 3 and Step 4? 

If the following are true, skip Steps 3 and 4:

  • Your consent form only requires the subject's signature.  
  • Your consent form DOES NOT require the signature of the study staff person obtaining consent.

This is typically true for minimal risk studies using the Information Sheet and Authorization consent form.

If your consent requirements meet the criteria above, skip ahead to the User Permissions section.

(tick) Complete Step 3 and Step 4?

If the following are true, complete Steps 4 and 5:

  • Your consent form requires documenting the study staff obtaining consent.
  • You're conducting real-time consent sessions with your subjects, over the phone, virtually, or in person.

This is typically true for more than minimal risk studies using the Consent & Authorization "full"consent form.


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Step 3: Build a Consent Attestation Form (to Document the Study Staff Obtaining Consent)

The consent survey completed and certified by the participant cannot be used to also capture documentation of the study staff obtaining consent. Editing a participant’s completed consent form for which the e-consent framework has been set up, to add the staff’s signature, would invalidate a participant’s consent, which is why we instruct you to configure the consent survey to be un-editable.

The solution is to build a separate form for documenting the study staff who obtained consent, enable that form to be a survey, configure the e-consent framework in the survey setting, and train study stuff to complete this form as a survey.

Modify a Template

Build from Scratch

  • If your are using a form template, upload the Study Staff - Consent Attestation zip file.
  • If you started your project from E. OCTRI Consent Template - Consent and Authorization, the Study Staff-Consent Attestation form is included in your project.
  • Click on the Attestation form to edit it.
  • Create a new form, named Study Staff - Consent Attestation.
  • Click on the form to edit it.

3A - Form Field for Instructions

(info) Edits are NOT needed to the descriptive text field for the instructions.

(plus) At the start of the form, add a descriptive text field with instructions for the study staff to open the form as a survey.

  • Use the Rich Text Editor to format the field
  • Add the following Action Tags:
    • @HIDDEN-SURVEY to hide the field when the subject views the consent form as a survey.
    • @HIDDEN-PDF to hide the field from being included in PDF copy/download.

Figure 12-S: descriptive test field for study staff instructions – Online Designer view

3B - Form Field for Approval and Expiration Dates

(tick) Edit the ICF approval and expiration dates descriptive text field as follows:

Figure 6-T: descriptive text field for dates - Online Designer view


(plus) Add a Descriptive Text field for the approval and expiration dates of your consent form.

  • Add the approval and expiration dates on separate lines.
  • Use the Rich Text Editor to unbold the dates.
  • Set the text to Align Right

Figure 13-S: Adding a descriptive text field for the approval and expiration dates

3C - Form Field to Verify Subject Name and Date of Consent

(info) Edits are NOT needed to the descriptive text field for verifying the subject name and date of consent, unless one of the following are true:

  • Your project is set up as longitudinal.
    • For piping the subject's last and first name, add the unique event name (of the event the consent form is assigned to) before the variable name.
  • You modified the variable names of the subject first and last name fields on the consent form.

Figure 7-T: Descriptive text field to verify consent subject's name the date of consent edited to include an event name - Online Designer view*

*[unique_event_name] - replace unique_event_name with the name of your event

(plus) At the start of the form, add a descriptive text field with the subject's name and date of consent to make it easy for the study staff to verify they are completing the form for the correct participant.

  • Pipe the subject's first and last names.
  • Pipe the timestamp of when the consent form was submitted, using the smart variable: [survey-time-completed:instrument].

Figure 14-S: Adding a descriptive text field to verify the consent subject's name and the date of consent

Figure 15-S: Descriptive text field to verify the consent subject's name and the date of consent - Online Designer view


3D - Form Field for Confirming Subject Consented

(info) Edits are NOT NEEDED to the Consent Attestation checkbox field unless one of the following are true:

  • Your project is set up as longitudinal.
    • For piping the subject's last and first name, add the unique event name (of the event the consent form is assigned to) before the variable name.
  • You modified the variable names of the subject first and last name fields on the consent form.

Figure 7-T: Descriptive text field to confirm the subject consented edited to include an event name - Online Designer view*

*[unique_event_name] - replace unique_event_name with the name of your event

(plus) Add a checkbox field with a single option for study staff to confirm they obtained consent for the participant.

  • Field label = Consent Attestation

  • Option label = I confirm [icf_fname] [icf_surname] gave consent.
    • Where [icf_fname] = the variable name of the first name field.
    • Where [icf_surname] = the variable name of the last name field.
  • Make this field required.

Figure 16-S: Adding a checkbox field for confirming the subject consented

Figure 17-S: Checkbox field for confirming the subject consented - Online Designer view

3E - Form Fields for Capturing the Signature of Study Staff Obtaining Consent

(info) Edits are NOT NEEDED to the following fields:

  • Date of Consent Attestation text field
  • Study Staff First Name text field
  • Study Staff Last Name text field

(plus) Add text fields for the study staff who obtained consent, to enter their first and last names, and the date they completed the attestation form.

  • Add a text field for capturing date of the staff complete this form

    • Field label = Date of Consent Attestation

    • Apply the Date (M-D-Y) field validation rule.

    • Make this field required

  • Add a text field for the study staff’s first name.

    • Make this field required.

  • Add a text field for the study staff’s last name.

    • Make this field required.

  • Add a text field for the study staff’s last name.

    • Make this field required.

Figure 18-S: Example of text fields for study staff's first and last names and date of completing form - Online Designer view

(info) Attestation Form - Online Designer View

Study Staff - Consent Attestation



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Step 4: Enable Consent Attestation Form to be a Survey

There are more than 20 elements that can be defined in the Survey Settings. We cover a subset of those elements in our instructions, focusing on what's required to support consent and what's related to best practices, as well as highlighting the key decision points associated with consenting online.

If you started your project from one of the Project Templates, the consent form has already been enabled as a survey and only a few modifications will be required. However, you should still review the settings outlined below so you can support the consent process for the project.

Survey Settings

4A - Basic Options

  • Edit the Survey Title to be unique.
    • We recommend using the study's short title + Agreement to Participate

  • Edit the Survey Instructions to include the contact information for the study team.
    • Additional instructions can help the subject understand how to interact with the consent survey AND this messaging will require IRB approval.

Figure S-8: Survey title and instructions - Survey Settings view

4B - Survey Design Options
  • Do not upload any image for the Logo.

  • Accept the default setting Standard radios and checkboxes for the setting: Use enhanced radio buttons and checkboxes? unless you anticipate the majority of subjects will be completing the consent survey on phone or tablet, in which case you select Enhance radios and checkboxes.

Figure S-9: Standard radios and checkboxes - Survey Settings view

4C - Survey Customizations
  • Select Custom Numbered for Question Numbering.
  • Select Yes for the setting: Allow participants to download a PDF of their responses at end of survey?
  • Accept the default selection, Yes, for the setting: For 'Required' fields, display the red 'must provide value' text on the survey page?

Figure S-10: Custom numbered for Question numbering - Survey Settings view

Figure S-11: Allow PDF downloads - Survey Settings view

Figure S-12: Display must provide value for required fields - Survey Settings view

Survey Access
  • Do not enable Save and Return.

Figure S-13: Save and Return disabled - Survey Settings view


Survey Termination Options
  • Edit the Survey Completion Text to include instructions for the study staff about accessing the PDF.

Figure S-14: Completion text - Survey Settings view


e-Consent Framework and PDF Auto Archiver
  • Select Auto-Archiver + e-Consent Framework.

Figure S-15: Auto-Archiver + e-Consent enabled - Survey Settings view


(warning) e-Consent Framework Options (subject signature required)
  • DO NOT check the box Allow e-Consent responses to be edited by users?
  • Enter your e-Consent version.

    • The version is included in the footer of PDF copy of the completed attestation survey.

  • For the First name field and Last name field, select the fields from the form that capture the study staff's first and last name.

    • The study staff's first and last names are included in the footer of PDF copy of the completed attestation survey.
  • Under Optional fields add Consent Attestation or Attestation for e-Consent Type.
  • Select the following signature settings for Force signature field(s) to be erased if participant clicks Previous Page button while on the certification page?

    • Signature field #1: Select the study staff's first name field.

    • Signature field #2: Select study staff's last name field.

Figure S-16: e-Consent configured - Survey Settings view


PDF Copy Stored in File Repository
PDF copies of the submitted consent and attestation forms are saved to File Repository > PDF Survey Archive.

Figure S-17: PDF copy of subject submitted consent survey and staff submitted attestation survey stored in the File Repository

Attestation Form Examples - Survey View

Open Attestation Form as Survey

Attestation Survey

e-Consent at the end of the Attestation Survey



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Create PDFs of e-Consent form(s) to IRB

IRB approves the consent forms set up in REDCap.


Steps
1Create a record for a test participant.
2Open the consent form as a survey.
3(warning) If the consent form requires the participant to enter their first and last names, select yes for agreeing to participate.

Selecting yes for consent on the consent survey

4From the browser's File menu, print the the page as PDF.

Accessing the File menu in Chrome


Saving as PDF in the print screen

5(warning) If the consent form requires the participant to enter their first and last names and documentation of the study staff obtaining consent, also print the Attestation Survey as a PDF.
6Consent survey printed as a PDF printed_pdf_example.pdf


Also include the following in your submission to the IRB

  • The message the displayed to the participant when the consent survey is submitted.
  • If you are emailing an invitation to the consent form, the subject line and message of the email. 
  • (warning) If the consent form requires the participant to enter their first and last names, note you are using using e-Consent framework with the certification step for the participant.


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