Page tree

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Easy Heading Free

HTML
<style>
	.heading-expand-header { cursor: pointer; }
	.heading-arrow { color: #e87500; }

	body { color: black; }
</style>
Note
titleDRAFT

Summary

The goal of this tutorial is to show the process required to use the following documentation details how to setup an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, "IRB: Consent to Participate in Research template located in REDCap. The Institutional Review Board approved this template (IRB), and it can be used to replace the paper version of the form for an electronic form. This form can be sent to participants as a survey to collect participants’ information and signatures electronically.

  • Activating External Modules (mentioned that they've been configured....and not change variable names because it may interfere with the EM functionality.)
  • Activate ASI
  • Make sure to select this field so that participants receive a copy (which causes the ASI to send email)
  • Go back and add researcher signature
  • How to access the PDF from researcher point of view
  • What it looks like when the participant receives a copy of the signature/process they must take (clicking link then downloading file etc.)

Create a new REDCap project using a template

Go to:

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.


Note

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

  1. Navigate to https://redcap.utdallas.edu and after entering your credentials, click ‘New Project.’
    Image Removed
    Enter project relevant information.Enter the Project Title based on the IRB information.log-in using your NetID and password.

  2. Create a new project by clicking "+New Project".
    Image Added

  3. Enter the following project relevant information:
    1. Project Title
    2. Select Research from the ‘Purpose of this project’ drop-down menu
    3. Enter important administrative Administrative details of the project such as the name of the P.I., email, IRB number, and moreetc.Image Removed
    Select ‘Use a template’ from the
    1. Specify the type of research that best applies
      Image Added

  4. Under the section Start project from scratch or begin with template? options.
    Select , se
  • Caution: DO NOT modify the shazam_1 field or the correct_answer_total field. These fields are used for branching logic and external modules.
  • Click the edit pencil on Question 1.
    Image Removed
     Replace the field label with the a question based on the consent form.
    Image Removed
    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.
    Image Removed
    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.
    Image Removed
    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.
    Image Removed

    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
    Image Removed
    Click 'Enable a Module.'
    Image Removed
    Search the module ' Paper Trail' and click Enable.
    Image Removed
    Repeat step 2 and 3 to find the and enable the additional modules, 'REDCap CSS Injector', 'Survey UI Tweaks' and 'Shazam'
    Image Removed
    Image Removed
    Image Removed
    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. 
    Image Removed
    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.'
    Image Removed
    You can associate another email with the account like an office or lab email address. 
    Image Removed
    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.
    Image Removed
    Do not change the branching logic in 'Step Two' since it affects the conditions needed to send the automated email to the participant.
    Image Removed
    Click Active to activate the ASI and then click Save. 
    Image Removed
    The ASI is now active.
    Image Removed

    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.

    1. Under ‘Applications’ on the right-hand side, select ‘User Rights’.
      Image Removed
      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 and click ‘Create (PI Signature Required) and click ‘Create Project.’
      Image Removed

    Modify the consent form text based on the project.

    To modify the consent form text click on ‘Designer’ under Project Home and Design or click ‘Online Designer’ under Design your data collection instruments & enable your surveys.
    Image Removed
    Click on 'Choose action' to Rename the form as need it the click on the instrument to modify the text.
  • Warning: Do not modify the fields and variables inside the instruments 'Participant Email' and 'Participant PDF Consent form' since they interfere with external modules functionalities.
     
  • Image Removed

    The consent temple contains 14 fields. Modify the text in red located in each field.

    1. To access a field, click the edit pencil on the top section of the field.
    Image Removed
    Click the Full-Screen icon on the editor bars.
    Image Removed
    Replace red text with study specific language and change the text color to black.
    Image Removed
    Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.
    Image Removed
    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.
    Image Removed
     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. 
    Image Removed
    Modify the consent question fields that will be used to determine if the participant read the consent.
    1. Image Added




    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.

    1. Navigate to Alerts & Notifications
      Image Added


    2. 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.
      Image Added

    3. Be sure to un-check the checkbox to see the newly activated alert.
      Image Added

    4. (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.
      Image Added


    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.

    1. Navigate to User Rights.
      Image Added

    2.  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.
      Image Removed
      Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’Image Added

    3. See the image below to view the access rights which pertain to each role.
      1. Lab Manager Role – The will have : Have complete control and access to the project. They have access to identifiable information.
      2. 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.
        Image Removed

    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.

    1. Moving
      1. exports.
        Image Added



    Modify Consent Language

    Modify the language in the consent so that it is specific to your project. 

    1. Navigate to the Online Designer
      Image Added

    2. (Optional) Click 'Choose action' and select 'Rename' to rename the form. 
       Image Added

    3. Click on the instrument name to modify the language in the consent. 
      Image Added


    4. Edit a field by clicking the pencil icon. Note: Text in red requires modification.
      Image Added


    5. Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
      Image Added

    6. 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. 
      Image Added


    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. 

    1. Click ‘Project Setup’

      tab on the top


      Image Added

    2. At the bottom of the page

      or the ‘Project Setup’ link located under ‘Project Setup and Design.’
      Image Removed
      After completing each of the seven steps, click ‘I am done!’
      Image Removed

      After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.

    3. 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.’

    4. If ‘Delete ALL data… ‘ is selected, a message box will open to confirm that you want to delete all the data.
    5. Click Yes, ‘Move Project to production’.
      Image Removed

      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.
      Image Removed
    InfoFor more information, please visit our website REDCap or send us an Email.
    1. , click the button 'Move project to production'
      Image Added

    2. 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.
      Image Added

    3. 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.

      Image Added


    Note

    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. 

    1. Navigate to the Record Status Dashboard.
      Image Added

    2. Click the green status icon for the instrument 'Consent to participate in Research' of the record that needs a researcher signature.
      Image Added

    3. Click 'Edit response.'
      Image Added

    4. Enter information in the following fields:
      1.  Researcher First Name
      2. Researcher Last Name
      3. Signature of Researcher Obtaining Consent
      4. Researcher Signature Date
        Image Added

    5. 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.
      Image Added


    Send Fully Signed Consent

    1. 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. 
      Image Added


    2. Click the radio-box '

    Access Consent Copy

    1. 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.
      Image Added

    2. Click on the file link to download the PDF copy of their e-consent.
      Image Added


    Info

    Need help? Contact: redcap-help@utdallas.edu

    Have IRB specific questions? Contact: irb@utdallas.edu