Summary
This tutorial's goal is to show the process required to use the IRB: Participant Health Screen template located in REDCap. Due to the current situation with Covid-19, the Institutional Review Board (IRB) recommends using the form as part of the screening process to reduce risk. The project consists of two forms. The first form will be used to pre-screen participants 24 hours in advance and the second form to screen participants once they arrive at the Lab.
Create a new REDCap project using a template
Go to: https://redcap.utdallas.edu and after entering your credentials, click ‘New Project.’
Enter project relevant information.
- Enter the Project Title based on the IRB information.
- Select Research from the ‘Purpose of this project’ drop-down menu.
- Enter important administrative details of the project such as the name of the P.I., email, IRB number, and more.
Select ‘Use a template’ from the Start project from scratch or begin with template? options.
From the template box, select IRB: Participant Health Screen and click ‘Create Project.’
Modify Form Fields and text (If Applicable)
Important message: Modification of the health screen forms needs approval from the IRB office.
To modify form fields and text, click on ‘Designer’ under Project Home and Design or click ‘Online Designer’ under Design your data collection instruments & enable your surveys.
Click on 'Choose action', then 'Rename' if the form title needs to be modified. Click on each instrument name to edit fields.
To modify a field, click the edit pencil on the top of the field section. To add additional fields, click on add fields.
In the 'Edit Field' box, users can modify the 'Field Type,' 'Field Label,' 'Variable Name,' and more.
a. The 'Field Type' drop-down menu offers 14 different options. The field type dictates how the field will be shown on the data entry form.
b. If adding a new field, add a new 'variable name.'
c. Input or modify text in the 'Field Label' text box and click 'Save.'
For more information about Online Designer and Field Types, visit the REDCap Training Videos and REDCap Help & FAQ.
Add Users and Define User Rights based on Project Roles
Each user's rights to access 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.
Click ‘User Rights’ located under 'Applications.'
a. 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.
Please advise: Users need to log in to REDCap at least once before they can be added to the project.
b. Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’
- Lab Manager Role – The user will have complete control and access to the project. They have access to identifiable information.
- 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.
Moving the project to production status requires the completion of seven steps located in the 'Project Setup' Section.'
Click the 'Project Setup' tab on the top 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 survey submission, the REDCap Administrator will be emailed to start approving your study. After approval, your project will be moved to production.
Adding Participants to the project
This section allows users to add participants and their answers during the screening process.
Navigate to the 'Data Collection' section and click 'Add/Edit Records.'
Click 'Add New Record.'
Click the 'Status' Icon for the Data Collection Instrument.
The '24 Hour Research Subject Screen' form must be completed a day before the participant's appointment.
The 'Session Research Subject Screen' form needs to be completed during the appointment.
Fill out the form:
- For Participant ID - Use the same participant ID that belongs to the person's record on your study.
- Complete all the fields before saving the form.
Insert comments based on the participant's assessment.
Once the form is filled, select 'Complete' from the Complete? drop-down menu.
If no additional participants, Select Save & Exit Record from the drop-down options.
You can also select 'Save & Go To Next Record' if additional participants need to be added.
Additional options when Saving a form are:
- Save & Stay
- Save & Go to the Next Form
- Save & Exit Form
After saving and exiting the record, REDCap will return to the 'Add/Edit Records' page.
A notification at the top of the page will show that a Record was successfully edited.
The page also provides a 'Total of Records' collected.
To access the second instrument, Session Research Subject Screen, click 'Record Status Dashboard' under the 'Data Collection' section.
Click the 'Status' Icon under 'Session Research Subject Screen.'
Fill out and Save the form, as previously mentioned in this document.
Click 'Record Status Dashboard' to review the status of completed records.
Completed records will have green icons on both instruments.
Visit the REDCap Training Videos and REDCap Help & FAQ for additional training. For more information, please visit our website REDCap or send us an Email.