Summary

This tutorial's goal The goal of this tutorial 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 four 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.

, the third form will be used to follow up with subjects five days after the screening, and the last form will be used to follow up with subjects 14 days after screening.

Create Project from Template

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

   Image RemovedImage Added
   
   

2. Enter project relevant information.

   1. Enter the Project Title based on the IRB information.
   2. Select Research from the ‘Purpose Purpose of this project’ dropproject drop-down menu.
   3. Enter important administrative details of the project such as the name of the P.I., email, IRB number, and moreetc.
      Image RemovedImage Added
      
      

3. Select ‘Use Use a template’ from template from the Start project from scratch or begin with template? options options. From Within the template box, select select IRB: Participant Health Screen Screenand click ‘Create click Create Project.’Image Removed

   Image Added

Modify Form Fields and text (If Applicable)

1. To modify form fields and text, click on

‘Designer’ under 

1. Designer under Project Home and Design

 or click ‘Online Designer’ under 

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.

Image Removed

1. or click Online Designer under Design your data collection instruments & enable your surveys.

Image Removed

1. Image Added
   
   

2. (Optional) Select Choose action, and then Rename if the form title needs to be modified. Click on each instrument name to edit fields.

   Image Added
   
   

3. To modify a field, click the edit pencil on the top of the field section. To add additional fields, click on

add fields

1. Add Fields.
   

Image Removed

1. Image Added
   
   

2. In the

'

1. Edit Field

'

1. box, users can modify the

'

1. Field Type,

' '

1. Field Label,

' '

1. Variable Name,

'

1. and more.

   1. The

'

1. 1. Field Type

'

1. 1. , a drop-down menu that offers 14 different options

. The field type

1. 1. , dictates how the field will be shown on the data entry form.

   2. If adding a new field, add a new

'

1. 1. variable name.

'

1. 2. Input or modify text in the 'Field Label' text box and click

'

1. 1. Save.

'

1. 1. 
      Image Added
      

Image Removed

Note
For more information about Online Designer and Field Types, visit

the

the REDCap Training Videos

and 

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 regularly during the study.

1. Click ‘User Rights’ Navigate to User Rights located under ' Applications.'
   Image Removed
   Add users to the project based on their roles.
   Image Added
   
   
2. Type the user’s NETID or name in the ‘Assign Assign new user’ user to role text box. A drop-down menu will provide options to select the correct user.
   Please adviseNote: Users need to log in to REDCap at least once before they can be added to the project.
   Image RemovedImage Added
   
   
3. Click ‘Assign Role’ and Assign Role, select between the role of ‘Lab Manager’ Data Manager and ‘Data Collector.’

Lab

1. Data Collector and then click Assign to confirm.

• • Data 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 exportexports.

Image RemovedImage Added

Change a REDCap

Move 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

When the project is ready to begin collecting real data, and you have tested that the project logic behaves as expected, a user must request to move their project to 'Production' status. Moving the project to Production status requires the completion of seven steps located

in

on 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.'
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.

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’.
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 survey submission, the REDCap Administrator will be emailed to start approving your study. After approval, your project will be moved to production.
Image Removed
Adding Participants to the project

page. Visit our Project Status guide to move a project to production.(WIP) Note: Any changes made to a project in Production must be approved by a REDCap administrator to protect the integrity of any collected data. 

Add Participants

This section allows users to add participants and their answers during the screening process.

1. Navigate to the 'the Data Collection' section and click ' Add/Edit Records.'
   Image RemovedImage Added
   
   

2. Click ' Add New Record.'
   Image RemovedImage Added
   
   

3. Click the 'Status' Icon for the Data Collection Instrument. The 'Each form needs to be completed at specific time intervals:

   1. 24 Hour Research Subject Screen

   '

   1. form must be completed a day before the participant's appointment.

   The '

   1. Session Research Subject Screen

   '

   1. form needs to be completed during the appointment.

   2. 5 Day Research Subject Follow Up form needs to be completed 5 days after the participant’s appointment.
   3. 14 Day Research Subject Follow Up form needs to be completed 14 days after the participant’s appointment.
      
   Image Removed
   1. Image Added
      
      

4. Fill out the form:

   1. For Participant ID - Use the same participant ID

   that belongs to the person's record on your study

   1. used within the primary data collection project.

   2. Complete all the fields before saving the form.

   Image Removed

   1. Image Added
      
      

5. 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 need to be entered at this time, 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:

   1. Save & Stay

   2. Save & Go to the Next Form

   3. Save & Exit Form

   Image Removed

   1. Save & Go to Next Record

      Image Added
      
      

6. After saving and exiting the record, REDCap will return to the 'Add/Edit Records' page. Record Home 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. 

   Image RemovedImage Added
   
   

7. To access the second instrument, Session Research Subject Screen, click 'Record Status Dashboard' under the 'Data Collection' section.
   Image Removed
   

   Click the 'Status' Icon under 'Session Research Subject Screen.'

   Fill out and Save conduct either the day of session screening or follow-up forms,click Add/Edit Records to use the Search query field to search for the Participant ID.
   Image Added
   
   

8. Click the Status Icon under the desired form. Fill out and savethe form, as previously mentioned in this document.

   Image RemovedImage Added
   
   

9. Click 'the Record Status Dashboard' to review the status of completed records. Completed records will have green icons on both all instruments.

   Image Added
   Image Removed