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 four forms. The first form will be used to pre-screen participants 24 hours in advance, 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
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, etc.
Select Use a template from the Start project from scratch or begin with template? options. Within 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.
(Optional) Select Choose action, and 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.
The Field Type, a drop-down menu that offers 14 different options, dictates how the field will be shown on the data entry form.
If adding a new field, add a new variable name.
Input or modify text in the 'Field Label' text box and click Save.
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 regularly during the study.
- Navigate to User Rights located under Applications.
- Type the user’s NETID or name in the Assign new user to role text box. A drop-down menu will provide options to select the correct user.
Note: Users need to log in to REDCap at least once before they can be added to the project.
- Click Assign Role, select between the role of Data Manager and 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 exports.
Move Project Status 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 on the Project Setup 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.
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.