e-Consent Framework (initial setup)

Obtaining consent is a critical step in the clinical research process. The type and extent of a project's e-Consent is driven by the project's IRB and is the responsibility of the Principle Investigator to ensure all IRB criteria are met and enforced.

If you are working on FDA regulated study, please begin your consent process following: CFR Part 11 Validated Projects
For any NON-FDA regulated studies, best practices are provided below, however it may be the case that not all components mentioned are necessary for your specific study

1 Summary of Tasks
2 Step 1: Build your e-consent survey instrument
3 Don’t want to build your E-Consent project from scratch? Use the template!
4 Step 2: Enable e-consent framework and settings
5 Step 3: Provide the completed consent PDF to participant
6 Step 4: Test consent process and storage to File Repository

Initial Considerations

REDCap implements electronic consent by utilizing 2 separate features found within the ‘online designer’.

It’s important to understand that the consent survey instrument and e-consent framework are 2 separate functions, working together! When these 2 functions are combined, REDCap provides a standardized method to obtain electronic consent.

The e-consent framework will always save a real time copy of the completed consent survey to your projects File Repository. However, the PDF snapshot tool allows you to string multiple ‘singular’ consent surveys and forms into a single PDF file.

PDF snapshot tool simply facilitates the merging and storage aspects of the consent.

Once stored, it is up to the study team to decide if/how/when they provide the pdf document to study participants based on the study’s IRB requirements.

For some it may be sufficient to simply have the combined file stored to their project for auditing purposes. For others, it may be the case that the combined pdf must always be provided to the participant.

Reminders:

Create a ‘practice’ project to first learn how to work with e-consent framework before implementing to your research project!
Add your consent expiration date to the end of your instrument name, as a visual reminder to upload your new version when the time comes. (E-Consent Exp 01/01/2026)
- This can be very helpful to avoid capturing an outdated consent
- Consent Versioning Process: Modify E-Consent: (version control)
When Consenting In-Person:
- For studies not subject to FDA regulation (21 CFR Part 11) that employ REDCap solely for in-person consent processes, it is permissible to incorporate up to five signatures within the consent document and integrate them into the established e-Consent framework.
Regardless of consent type (remote or in-person) both require the study team’s capture of documentation of informed consent separately using a data entry instrument.
- You can use our template to see what’s captured in this instrument, or build your own.
For E-Consent to be valid it must always be captured in ‘SURVEY MODE’ :

Summary of Tasks

There are 4 key steps to configuring your e-consent. Additional information for each task is provided in detail in the (steps) sections.

Consent Survey Instrument
1. This hosts your required consent field(s) such as:
  1. Date of consent
  2. A blank Descriptive field for your PDF consent document (details covered later on in this article)
  3. Any yes/no or discrete fields found in your consent document (e.g. participant agrees to dna storage, future contact, etc.)
  4. First Name, Last Name
  5. Signature
E-Consent Framework
1. Setting up the framework for the first time is a 3 step process
  1. Enable Consent survey with Framework
  2. Configure e-consent Framework settings
    - Required settings
    - Storage settings
  3. Uploading your PDF consent document
Provide completed consent PDF to participant
1. Singular automated document
2. Combined PDF document & delivery methods
Process, Storage, and Delivery Testing

Step 1: Build your e-consent survey instrument

Don’t want to build your E-Consent project from scratch? Use the template!

The template comes with the needed pre-built instruments and settings to get you started!

We suggest creating a ‘practice’ project with the template to become familiar.

Template Instructions here

Only follow the below instructions if you aren’t going to use one of the econsent templates.

	INSTRUCTIONS: Click on images to expand

	INSTRUCTIONS: Click on images to expand
1	Enable surveys on the "Project Setup" page by pressing the Enable button.
2	Create e-consent survey instrument via Online Designer page Click to +Create your Consent Survey Instrument Suggested Instrument name: (consent type) (expiration date) Instrument name: reflects what project users will see when working in REDcap Add your consent expiration date to the end of your instrument name, as a visual reminder to upload your new version when the time comes Enable the instrument as survey Click ‘enable’ You’re dropped into the ‘survey settings’ to update Survey Title if desired- By default Survey title is the instrument name, however you may choose to change the title now Survey Title: reflects what text appears at the top of the participant's survey page. Click ‘Save Changes’
3	Click to modify the survey instrument via the online designer page Click ‘Add a field’ Field Type: Descriptive Text Variable Name: ‘consent_document’ Do NOT upload or input any other information to this field. The actual PDF document will be uploaded via the framework function later on!
4	Create additional fields needed to capture your consent signature block components. This instrument is used to capture ONLY the participants part of the consent process. The study team will perform their sign-offs in a different instrument called ‘Documentation of Informed Consent”. You will NOT capture the study teams name/signature on the participant’s consent instrument.
5	Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, future contact, etc.
6	Ensure Signature fields are stand alone, and never embedded! Embedding signature fields will result in an invalid consent as the file that is then saved to your file repository will not host the participant's signature!
7	Proceed to next section below!(Enable e-consent framework and settings)

Step 2: Enable e-consent framework and settings

	INSTRUCTIONS: click on images to expand

	INSTRUCTIONS: click on images to expand
1	Navigate to ‘online designer’ page
2	Click ‘e-consent framework and PDF snapshot’
3	Click ‘Enable the e-consent framework for a survey’ then select the consent survey you created in Step 1.
4	Complete the e-consent settings based on what’s required to be captured in your signature block (name, signature, etc.) NEVER select the ‘Allow e-Consent responses to be edited’ option, always leave de-selected. Select Primary Fields: Select first name Select last name Setup additional settings, if desired.
5	Select Signature field (typically required for most consent documents) Save Settings
6	Click ‘+ Add Consent Form’ this is where you will input version details and your PDF document
7	REMINDER: Upon clicking the "Add new consent form" button (in the next steps), the new consent form will GO LIVE IMMEDIATELY within your e-Consent survey! If a mistake is made you may correct by making a new version of your consent document within the framework setting. Ensure all inputs are correct before clicking the "Add new consent form" button
8	Select required fields: Version number This is your ‘redcap’ version number not your IRB version number. If you’ve not yet collected any consents,this should likely be 1.0. Select the ‘consent_document’ field for the placement of consent form. Select ‘Consent form in-line PDF’ option at the bottom of the page Select PDF consent file Confirm the file name shown is correct. DAG groups & MLM If using DAG groups or MLM functions, you will have ‘multiple’ active versions of this single survey, per DAG/MLM grouping. You create a version for each group by repeating step 6 and 7 in this process. example: Review setup for correctness before clicking ‘Add new consent form’ Finalize by clicking ‘Add new consent form’
9	To automatically send the participant a copy of their completed consent survey, proceed to the next section (3)

Step 3: Provide the completed consent PDF to participant

(3a) How to automatically send a singular, non-combined document:

	INSTRUCTIONS: click on images to expand

	INSTRUCTIONS: click on images to expand
1	Ensure you first, Designate & Enable a survey participant email field The below process only works if the participants email field is captured before or within the consent survey instrument.
2	Navigate the your e-consent instruments ‘survey settings’
3	Scroll to the bottom of the survey settings page
4	Select 'Send confirmation email?’ setting to ‘YES’
5	Ensure the ‘from’ sender utilizes a study members/team email so users can contact you. Do NOT leave ‘redcap’ as the from sender, if you do, when a participant responds to contact the study team, the study team will not be notified!! Input subject, line and Encrypt the subject line to meet University Policy!! Since the consent will host PHI/PII, you MUST encrypt the subject line Subject line encryption options: PHI, [encrypt], [secure] Check ‘Include PDF of completed survey as attachment’
6	Click ‘Save Changes’

(3b) How to configure & auto-deliver a combined PDF document:

In this example we are combining 2 completed surveys: Participant ICF and LAR consent

Create your combined consent copy survey:
1. Access the instrument to create your ‘file upload’ field:
  1. Field Type: File upload
  2. Variable Name: combined_consent
  3. Field label: (provide appropriate instructions)
  4. Alignment: Left Vertical
  5. Action Tags: @INLINE @READONLY
    - @READONLY action tag restricts the user from mistakenly deleting the file
2. Optional: consider hiding the ‘submit’ button via ‘survey settings’ so the user can re-access at anytime.
Configure the combined document via PDF Snapshot tool:
1. Navigate to PDF snapshot tool via online designer
2. Click ‘Add a new trigger’
3. Configure PDF
  1. Trigger Conditions: We suggest using the associated ‘completion’ fields within the logic box as the trigger. This ensure the pdf is only stored once both surveys are truly complete
  2. Scope of snapshot: Select as appropriate
    - For this example, we select participants ICF and LAR consent forms
  3. Location to save/ storage: We suggest both selections are used (file repo & specified field)
    - To automate delivery of the combined PDF to an end user, you must use the specified field! Select your ‘combined_consent’ field
  4. Save
Configure your ASI:
1. NOTE: If using an ASI to deliver consents to different users (LAR, Witness, etc) there is a ‘survey specific email field’ found within ‘survey settings’ which allow you to dictate a specific email field be used, that is different than the email ‘designated’ for communications at the project level.
  - By default the ASI will use the project level email field if no survey specific email field is selected in survey settings.
2. Configure and save per normal ASI guidance, however for step 2 (Conditions), use the SAME logic utilized in the pdf snapshot trigger.

Using the same logic is critical! It allows the survey invite to be sent giving end users the ability to download a copy:

Here is an example of the survey that hosts the combined file:

Step 4: Test consent process and storage to File Repository

Instructions: Test the process as if you were the participant!

Instructions: Test the process as if you were the participant!

Navigate to ‘record status dashboard'

Click to ‘Add new record’

Note: if the participants email field is captured before the consent survey, be sure to add you email there so you can test the PDF copy get accurately delivered!

Access consent survey

Click ‘survey options’ > Open survey
- If you don’t see this option, you must first click ‘save & stay’
Complete the survey as if you were a participant
- Certify and submit survey
Click ‘Close Survey’
Navigate back to project and click ‘leave without saving changes’

The record should look similar to this:

Navigate back to your project to access the ‘file repository tool’

View PDF Survey Archive folder
Download and review pdf file and folder for accuracy

Await your PDF Consent copy email confirmation (Be patient! Email may take longer than expected to deliver based on many factors)

Review email for accuracy
Make any adjustments if needed

These Knowledge Articles have been developed by the University of Utah’s REDCap Analysts using data garnered from the REDCap Consortium Library and other REDCap Affiliate members’ online resources and documents.

Utah CTSI REDCap Support