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Summary
The goal of this tutorial is to show how to use the following documentation details how to setup an approved Institutional Review Board (IRB) approved electronic consent form template in REDCap. REDCap allows for the ability to send the consent from as a survey link via email and can capture participants’ information and electronic signatures.
Create a new REDCap project using a templateconsent (e-consent) using the customized REDCap template, "IRB: Consent to Participate in Research Template (PI Signature Required)". This template should not be confused with the "IRB: Web Consent Form Template", as this template requires a researcher to sign a participant's e-consent, which requires additional project setup.
The e-consent process works as follows: (1) the e-consent is emailed to participants as survey link, (2) the e-consent will capture participant information and their electronic signature (e-signature), (3) researcher will sign the e-consent, (4) researcher will send the participant an email with a PDF copy of the fully signed e-consent.
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Setting up a New Project
Create Project from Template
- Navigate to https://redcap.utdallas.edu and log-in using your NetID and password.
INSERT IMAGE - Create a new project by clicking "+New Project".
- Enter the following project relevant information.:
- Enter the appropriate Project Title.
- Select Research from the ‘Purpose of this project’ drop-down menu
- Enter important administrative Administrative details of the project such as the name of the P.I., email, IRB number, etc.
- Specify the type of research that best applies
- Under the section Start project from scratch or begin with template, se
Replace the field label with the a question based on the consent form.
On the Choices section, replace the answers. Input wrong answers in choice 1 and choice 2. Input the correct answer in choice 3. Do not change the variable name since it affects branching logic and external modules.
Repeat steps 10 and 11 on Questions 2 and 3.Notice that the choices are in different order. Remember that in choice 3 you need to input the right answer for the external module and branching logic to work correctly.
Feel free to modify the incorrect_answer and correct_answer fields text, but do not change the branching logic and the variable names since they affect the branching logic.
Activate the External Modules
The External Modules are already pre-configured on the template. Reminder: Do not change variable names that can affect the behavior of the external modules. The modules needed for the template to work properly are: Paper Trail, REDCap CSS Injector, Survey UI Tweaks and Shazam.
|Click on External Modules located on Applications
Click 'Enable a Module.'
Search the module ' Paper Trail' and click Enable.
Repeat step 2 and 3 to find the and enable the additional modules, 'REDCap CSS Injector', 'Survey UI Tweaks' and 'Shazam'
You should see all 3 modules in the Currently Enabled Modules list.Reminder: Do not make modifications to the external modules since they are already configured to work with the instruments.
For more information about external modules contact the REDCap Admins.
Activate the Automated Survey Invitations (ASI)
Click on the 'Automated Invitations' button that belongs to the instrument 'Participant PDF Consent form.'
You can associate another email with the account like an office or lab email address.
The text in the paragraph is an example of what the participants will get when they receive the email asking them to access their copy of the consent. Feel feel to modify the text accordingly but do not remove [survey-link] or [survey-url]. The survey link and URL brackets are used to provide participants access to their survey.
Do not change the branching logic in 'Step Two' since it affects the conditions needed to send the automated email to the participant.
Click Active to activate the ASI and then click Save.
The ASI is now active.
Add Users and Define User Rights based on Project Roles
The rights of each user accessing a project must be defined depending on the user’s profile and role in the study. It is recommended to check all access rights on a regular basis during the study.
- Under ‘Applications’ on the right-hand side, select ‘User Rights’.
Add users to the project based on their roles.Type the user’s NETID or name in the ‘Assign new user’ text box. A drop-down menu will provide options to select the correct user. lect the IRB: Consent to Participate in Research (PI Signature Required) and click ‘Create click ‘Create Project.’
Modify the consent form
To modify the consent form and tailor it to your project, click on ‘Designer’ under "Project Home and Design" section or click ‘Online Designer’ under "Design your data collection instruments & enable your surveys".
Click on 'Choose action' to Rename the form. Click on the name of the instrument to modify the form's content.
The consent temple contains 14 fields. Modify the text in red.
- To edit a field, click the pencil on the top left of a field.
Click the Full-Screen icon to better view the content in a field.
Once the red text has been replaced by project specific language, don't forget to change the text to black.
Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.
The form contain fields for the Researcher's name, signature and date. These fields are hidden while the participant is taking the survey and are meant to be completed after the participant completes the survey.
Warning: The field 'Send signed consent copy to participant' cannot be modified since it affects the Automated Survey Invitations tool that sends the completed copy of the consent to the participant.
Modify the consent question fields that will be used to determine if the participant read the consent.
Enable Alerts & Notifications
This template uses a pre-configured "alert" to send participants an email with a PDF copy of their signed consent. When the project is first created, the alert is deactivated and must be re-enabled.
- Navigate to Alerts & Notifications
- Click the checkbox 'Show deactivated alerts'. When the box is checked, a pre-configured alert will appear. In the Options drop-down, select 'Re-enable alert' to enable the alert.
- Be sure to un-check the checkbox to see the newly activated alert.
- (Optional) Edit the alert to customize the email message. For example, you may want to add a Lab or Study name in the body of the email. Note: DO NOT edit the "trigger alert" logic, the "Email To" field, or the "File Upload Field". If these settings are altered, the email may not send as expected.
Add Users and Define User Rights
Add users to the project and define their access rights by assigning them pre-defined user roles. Each role has pre-defined project access rights. Note: It is recommended to review and update who has access to the project throughout the duration of the study.
- Navigate to User Rights.
- Type a user’s NetID or name in the ‘Assign new user’ box. Select the correct user from the drop-down and click relative role to complete adding the user to the project. Note: Users need to log in to REDCap at least once before they can be added to the a project.
Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’
- See the image below to view the access rights which pertain to each role.
- Lab Manager Role – The will have : Have complete control and access to the project. They have access to identifiable information.
- Data Collector Role – The user will have : Have the ability to create, view, and edit records. Data will be is de-identified when performing data export.
Change a REDCap Project Status to Production
This section will provide the necessary steps to change the project status from Development to Production. Completing these steps allows users to collect real study data. Additionally, it limits the risk of committing real-time changes to the project, which protects the data already collected.
- Moving
- exports.
- exports.
Modify Consent Language
Modify the language in the consent so that it is specific to your project.
- Navigate to the Online Designer
- (Optional) Click 'Choose action' and select 'Rename' to rename the form.
Click on the instrument name to modify the language in the consent.
- Edit a field by clicking the pencil icon. Note: Text in red requires modification.
- Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
- The form contains fields for the Research personnel's name, signature, and date; these fields are hidden from the participant when they are filling out the e-consent form.
Move Project Status to Production
When the project is ready to go live, and you have tested that the project logic behaves as expected, you must request that the project be moved to 'Production'. Moving the project to production status requires the completion of seven steps located in the ‘Project Setup’
Section’page. Note: Any changes made to a project in Production must be approved by a REDCap admin to protect the integrity of any collected data.
Click ‘Project Setup’
tab on the top
At the bottom of the page
or the ‘Project Setup’ link located under ‘Project Setup and Design.’
After completing each of the seven steps, click
‘I am done!’
After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.
Select ‘Keep ALL data saved so far’ or ‘Delete ALL data, calendar events, documents uploaded for records/responses, survey responses (if applicable), and any logging events pertaining to data collection.’
- If ‘Delete ALL data… ‘ is selected, a message box will open to confirm that you want to delete all the data. Click Yes, ‘Move Project to production’.
Complete the survey Move My Project to Production provided by the Office of Research Information Systems. The survey will guide you on moving your project to production more efficiently.
Upon submitting the survey, the REDCap Administrator will be emailed to start approving your study. After approval, your project will be moved to production.
Survey Notifications
Users can set up survey notifications to receive emails when a participants completes a survey.
Click on 'Survey Notifications' located under Survey options.
Select the email from the dropped down menu on the first table and click Close.
Adding a signature to a completed survey and triggering the ASI response.
After the participant completes the survey, the researcher/PI needs to access the record to input his/her information and signature. And select the response that triggers REDCap to send an email to the participant to access the completed consent.
- After the participant completes the survey, click on Record Status Dashboard.
Click the Status icon for the 'Consent to participate in Research' instrument that belongs to the new record.
the button 'Move project to production'
A window will pop-up asking if all existing data should be kept or deleted. It is highly recommended to delete all test data when moving a project to Production. Click the 'YES, Move to Production Status' to complete the request.
A window will pop-up with a questionnaire survey that is intended to capture information about the project and to serve as a check-list to ensure the project has been sufficiently tested. A REDCap administrator will receive the request and approve the move to Production. When the request is approved, the researcher will be notified via e-mail.
| Note |
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Signatures & Consent Copy
Add Researcher Signature
When a participant completes signing and submitting their e-consent, a researcher must also sign the e-consent and then send a copy to the participant.
- Navigate to the Record Status Dashboard.
- Click the green status icon for the instrument 'Consent to participate in Research' of the record that needs a researcher signature.
- Click 'Edit response.'
- Complete Enter information in the following fields:
- Researcher First Name of
- Researcher Obtaining ConsentLast Name
- Signature of Researcher Obtaining Consent
- Date Click the 'Send signed consent copy to participant.' choice to ensure the ASI is triggered and it sends the email the Participant to access the completed consent.
Researcher: Access and download the Participant's PDF copy (If necessary)
Click Record Status Dashboard to access record.
Click the Status icon for the 'Participant PDF Consent form' instrument that belongs to the new record.
Click on the link located under Record ID named Completed_Consent_PDF_xxx_xxx_xxx.pdf.
The PDF will be stored on the computer's downloads folder or it will open automatically, depending on the browser and computer settings. The top label includes the Project ID, Record ID, Date and time.
Go back to REDCap and click Save& Exit Record to close the record.
Participant's email notification and access to completed consent form.
Reminder: Researcher needs to signed, date and click the '
The participant will receive an email titled Consent Form Participant Copy.
Any of the two links will provide the participant access to the survey where they can download the PDF.
After the survey opens, the participant needs to click on the PDF link to download the pdf.
The PDF will be stored in the computer's downloads folder or it will open automatically, depending on the browser and computer settings.
- Researcher Signature Date
- Researcher Signature Date
- Save the record by choosing the option in the drop-down 'Save & Mark Survey as Complete.' Note: The record MUST be saved this way in order to update the PDF so that it includes the added researcher signature.
Send Fully Signed Consent
- Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form' of the record which has a fully signed e-consent that needs to be sent to the participant. Note: When the status icon is red, this indicates that the e-consent copy may not have yet been sent to the participant.
- Click the radio-box '
Access Consent Copy
- Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form' of the record that belongs to the desired participant.
- Click on the file link to download the PDF copy of their e-consent.
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Need help? Contact: redcap-help@utdallas.edu Have IRB specific questions? Contact: irb@utdallas.edu |