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titleDRAFT


Summary

The goal of this tutorial is to show the process required to use the 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

  1. Go to: https://redcap.utdallas.edu and after entering your credentials, click ‘New Project.’



  2. Enter project relevant information.
    1. Enter the Project Title based on the IRB information.
    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, and more.



  3. Select ‘Use a template’ from the Start project from scratch or begin with template? options.

  4. Select IRB: Consent to Participate in Research (PI Signature Required) and click ‘Create Project.’





Modify the consent form text based on the project.

  1. 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.



  2. Click on 'Choose action' to Rename the form as need it the click on the instrument to modify the text.
    1. 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.
       


  3. 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.



  4. Click the Full-Screen icon on the editor bars.



  5. Replace red text with study specific language and change the text color to black.



  6. Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.



  7. 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.



  8.  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. 



  9. Modify the consent question fields that will be used to determine if the participant read the consent.
    1. Caution: DO NOT modify the shazam_1 field or the correct_answer_total field. These fields are used for branching logic and external modules.
    2. Click the edit pencil on Question 1.



  10.  Replace the field label with the a question based on the consent form.



  11. On 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.




  12. 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.




  13. 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.

  1. |Click on External Modules located on Applications



  2. Click 'Enable a Module.'



  3. Search the module ' Paper Trail' and click Enable.



  4. Repeat step 2 and 3 to find the and enable the additional modules, '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.



Activate the 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 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’.



  2. Add users to the project based on their 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 – The will have complete control and access to the project. They have access to identifiable information.
    2. Data Collector Role – The user will have the ability to create, view, and edit records. Data will be 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.

  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 production.




Survey Notifications

Users can set up survey notifications to receive emails when a participants completes a survey.

  1. Click on 'Survey Notifications' located under Survey options.



  2. 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. 

  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 Save & and Exit Records from the drop down options located in the floating menu or at the bottom of the page.






Researcher: Access and download the Participant's PDF copy (If necessary)

  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.



  4. 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.



  5. 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 '

  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.



  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.