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titleDRAFT


Summary

The goal of this tutorial is to show how to use the 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.



Setting up a New Project


Create Project from Template

  1. Navigate to https://redcap.utdallas.edu and log-in using your NetID and password.
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  2. Create a new project by clicking "+New Project"


  3. Enter project relevant information.
    1. Enter an appropriate Project Title.
    2. Select Research from the ‘Purpose of this project’ drop-down menu
    3. Enter important administrative details of the project such as the name of the P.I., email, IRB number, etc.


  4. Under the section Start project from scratch or begin with template, select the IRB: Consent to Participate in Research (PI Signature Required) and click ‘Create Project.’



Enable External Modules

Enable the following External Modules:

  • Paper Trail
  • REDCap CSS Injector
  • Survey UI Tweaks
  • Shazam.

To enable a module:

  1. Click on External Modules located in Applications section of the left menu pane.


  2. Click 'Enable a module.'


  3. In the list, search for the correct module nd click Enable.


  4. Repeat steps 2 and 3 until you've enabled all of the modules listed above. , 'REDCap CSS Injector', 'Survey UI Tweaks' and 'Shazam'






  5. You should see all 3 modules in the Currently Enabled Modules list.
    1. 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.

NEED TO SHOW HOW Paper Trail & Shazam  MODULE IS CONFIGURED. Including how certain modules require admin approval before they can be activated. 


Activate Automated Survey Invitations (ASI)

  1. Click on the 'Automated Invitations' button that belongs to the instrument 'Participant PDF Consent form.'


  2. You can associate another email with the account like an office or lab email address. 


  3. 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.


  4. Do not change the branching logic in 'Step Two' since it affects the conditions needed to send the automated email to the participant.


  5. Click Active to activate the ASI and then click Save. 



  6. The ASI is now active.


Add Users and Define User Rights

The rights of each user accessing a project are defined depending on their role in the study. It is recommended to check access rights on a regular basis thought the duration of the study.

  1. Under ‘Applications’ on the left menu pane, select ‘User Rights’.


  2. Add users to the project based on their respective roles.
    1. 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. Users need to log in to REDCap at least once before they can be added to the project.


  3. Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’
    1. Lab Manager Role – Have complete control and access to the project. They have access to identifiable information.
    2. Data Collector Role – Have the ability to create, view, and edit records. Data is de-identified when performing data export... clarify with Danny





Modify Consent Language

  1. To modify the consent form and tailor the language specific to your project, click on ‘Designer’ under the 'Project Home and Design section or click ‘Online Designer’ under 'Design your data collection instruments & enable your surveys' in the project Settings.


  2. Click on 'Choose action' to Rename the form. To begin modify the language on the consent, click on the name of the instrument. 
    Warning: Do not modify change the variables or variable names of the    'Participant Email' and 'Participant PDF Consent form'  fields.  Any changes to these fields may break the logic implemented to obtain both the participant and researcher signatures. NEED TO TAKE NEW SCREENSHOT
     

  3. To edit a field, click the pencil icon. Modify the text in red. 


  4. Click the Full-Screen icon to better view the content in a field.


  5. Once the red text has been replaced by project specific language, don't forget to change the text to black.


  6. Click Save and continue and continue modifying the language for each field. 



  7. The form contain fields for the Researcher's name, signature and date, date, and send copy of signed consent to particpant. These fields are hidden while the participant is taking the survey and are meant to be completed after the participant completes the survey.
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     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 participantconsent form
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  8. Modify the consent question fields that will be used to determine if the participant read the consent. Caution: DO NOT modify the shazam_1 field or the correct_answer_total field. These fields are used for branching logic and external modules.
    1. Click the edit pencil on Question 1.


  9.  Replace the field label with the a question based on the consent form. Talk to Danny about branching logic.



  10. On In the 'Choices' section, replace the answers. Input wrong answers in choice 1 and choice 2. Input the correct answer in choice 3. 
    1. Do not change the variable name since it affects branching logic and external modules.



  11. Repeat steps 10 and 11 on Questions 2 and 3.
    1. 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.




  12. Feel free to You may modify the incorrect_answer and correct_answer fields text, but do not change the branching logic and or the variable names since they affect the branching logic.


Change 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.Once you've fully tested that the project logic behaves as expected, and you are ready for the project to go 'live', you must request that the project be moved to 'Production'. Any changes made to a project Production must be approved by a REDCap admin to protect the integrity of any collected data. 

  1. Moving the project to production status requires the completion of seven steps located in the ‘Project Setup’ Section’

    1. Click ‘Project Setup’ tab on the top of the page or the ‘Project Setup’ link located under ‘Project Setup and Design.’


  2. After completing each of the seven steps, click ‘I am done!’


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

    1. 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.’

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



  4. 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 productionAfter requesting to move a project to Production, you will receive a questionnaire via email to ensure you've fully tested the project and are aware....

    Once a REDCap Administrator approves the project's move to Production, you will be notified via email....



Signatures & Consent Copy

Adding a signature to a completed survey and triggering the ASI response.

Add Researcher Signature

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. their information, signature, and to trigger an email with the attached consent.

  1. After the participant completes the survey, click on Record Status Dashboard.


  2. Click the Status icon for the 'Consent to participate in Research' instrument that belongs to the new record. 


  3. Click 'Edit response.'


  4. Complete the following fields:
    1. Name of Researcher Obtaining Consent
    2. Signature of Researcher Obtaining Consent
    3. Date
    4. Click the '
  5. To save the record, select Click the button 'Save & and Exit Records from the drop down options located in the floating menu or at the bottom of the page.
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Researcher's
  1. Record' to save the changes made.
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Access Consent Copy

  1. Click Record Status Dashboard to access record.


  2. Click the Status icon for the 'Participant PDF Consent form' instrument that belongs to the new record. 


  3. Click on the link located under Record ID named Completed_Consent_PDF_xxx_xxx_xxx.pdf .
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    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.
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    Go back to REDCap and click Save& Exit Record to close the record.
    Image Removedto download the PDF.
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Participant's Consent Copy via Email

Reminder: Researcher needs to signed, date and click the '

  1. The participant will receive an email titled Consent Form Participant Copy.


  2. Any of the two links will provide the participant access to the survey where they can download the PDF.


  3. After the survey opens, the participant needs to click on the PDF link to download the pdf.

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  4. The PDF will be stored in the computer's downloads folder or it will open automatically, depending on the browser and computer settings.




Info

For more information, please visit our website REDCap or send us an Email.

For IRB specific questions, please email: irb@utdallas.edu