How to Get and Use ISARIC Approved Case Report Forms

Introduction

ISARIC has approved a variety of Clinical Report Forms (CRFs) for different diseases, studies, and scoring systems. This guide demonstrates how to effectively use the ISARIC-approved CRFs. Whether you access the template through a Direct Link or using the Templates menu within BRIDGE, you can modify the CRF to meet your specific needs.

For detailed instructions on customizing your CRF, see the Getting Started with BRIDGE tutorial.

Direct Links

Direct links take you directly to the BRIDGE web application with the relevant template selected and the CRF name pre-filled. All you need to do is click the “Generate” button. Below are some direct links:

• Mpox: https://isaric-bridge.replit.app/main/?param=Disease_Mpox
• Dengue: https://isaric-bridge.replit.app/main/?param=Disease_Dengue
• H5Nx: https://isaric-bridge.replit.app/main/?param=Disease_H5Nx
• COVID: https://isaric-bridge.replit.app/main/?param=Disease_Covid

Templates

Templates are pre-selected groups of questions. Users can click on the Templates tab and select those they want to include in the CRF.

ISARIC templates allow users to start the CRF creation process based on a set of pre-selected questions that ISARIC has curated for a particular disease or score.

Disease templates have been generated by the ISARIC network and have followed the CRF creation process that seeks to ensure that the questions included in such CRFs are adequate and sufficient to answer pertinent research questions. If you want to know more about the ISARIC creation process, please write to data@isaric.org.

Score templates are subsets of questions necessary to compute commonly used clinical scores, for example, the Charlson Comorbidity Index or SOFA.

If multiple templates are selected, the obtained CRF is the union of the questions from all the selected templates.

BRIDGE Output Files

BRIDGE generate the following files:

• ISARIC Clinical Characterization XML: This file can be used to generate a REDCap project. It contains the clinical characterization structure that can be uploaded to REDCap to generate a project that allows data capture in the ARC structure.
• REDCap Data Dictionary: This file can be used to add the specific forms and questions selected in BRIDGE to the REDCap project.
• Paper-like CRF: This is a PDF file that can be printed and used to collect data manually, allowing sites that cannot capture data electronically to collect information that can later be uploaded to the REDCap database.

How to Use BRIDGE Generated Files

As mentioned, BRIDGE generates three files:

• ISARIC Clinical Characterization XML: This XML file can be used to create a project in REDCap. To do this, navigate to the 'Project Setup' section in REDCap, and under 'Design your data collection instruments & enable your project,' click on 'Upload Instrument Zip file' and upload the XML file generated by BRIDGE.

• This file creates a REDCap project with the following event structure:

• REDCap Data Dictionary CSV: This CSV file can be used to update an existing REDCap project. Go to the 'Data Dictionary' section in REDCap, click 'Choose File,' and upload the CSV file generated by BRIDGE. Click 'Upload File' to apply the changes.

• Paper-like CRF: This PDF file can be printed and used for manual data capture in sites that cannot collect data electronically. The collected data can later be entered into the REDCap database.