Case Report Forms

Case Report Forms in the ISARIC Clinical Epidemiology Platform

Clinical data are the cornerstone of an evidence-based outbreak response, impacting decisions at both clinical and policy levels. Rapidly identifying case definitions, outcome rates, and risk factors is crucial for managing novel infections and unexpected epidemiological shifts. This relies on robust and standardised data collection that is flexible to the requirements and the resources available to local sites. We have processes for generating Case Report Forms (CRFs) that address the following challenges:

  • Limited time for data collection: Frontline healthcare workers and research staff lack time to collect data, especially limited in low-resource settings, where electronic health records (EHRs) are scarce and disease outbreaks are frequent.

↳ ISARIC CRFs take the most efficient approach to address critical knowledge gaps.

  • Ensuring comparable data: Maintaining high data quality and consistency is crucial, especially during outbreaks where discrepancies and inconsistent data collection methods can compromise integrity and limit comparability with other locations or diseases.

↳ ISARIC CRFs ensure standardisation for global comparison.

 

ARC (Analysis and Research Compendium)

ISARIC ARC is a comprehensive library of questions that can be used to rapidly build standardised CRFs for disease outbreaks. It covers a wide range of patient-related information, including demographics, comorbidities, signs and symptoms, medications, outcomes, and more. Each question in ARC has specific guidelines and relevant parameters, such as definitions, answer options, units, minimum and maximum limits, data types, and more. ARC has been designed to have these key features: 

  • Machine-Readable: ARC is provided in CSV format, making it easy for automated systems to read and process the data. 
  • Open Access: ARC is maintained on the software development platform GitHub, and is made freely and openly available for the research community.
  • Version Control: We continue to improve ARC by adding new questions and implementing structural changes. We maintain the history of changes made to ARC using GitHub’s version control. This allows users to return to any previous version of ARC, and ensures document integrity, traceability of changes, and seamless collaboration among researchers. For more information about the current version of ARC, please visit the ISARICResearch GitHub repository for ARC. The repository explains the variables, lists of answer options, and the template CRFs that are included in this ARC version. Previous ARC versions may be accessed via this repository’s releases. Additional questions can be added to future ARC versions by contacting us at: data@isaric.org.
  • Integration with the Clinical Epidemiology Platform: If you’re using the BRIDGE software tool (see below), it connects to this GitHub repository to access the current version of ARC for CRF generation. 

ISARICResearch GitHub – ARC

ISARICResearch GitHub – ARC Versions

BRIDGE (BioResearch Integrated Data tool GEnerator) 

ISARIC BRIDGE is a web-based application for users to create a Case Report Form (CRF) and tailor it to the context of an outbreak. BRIDGE operationalises ARC, the library of questions, for this. BRIDGE is designed to allow users to: 

  • Choose: Users may choose the ARC questions, or sections of related questions, that they want to include in their CRF. Users can also start with an ISARIC ARChetype CRF by clicking on the Templates tab. These are defined CRFs with questions most relevant to a specific disease or syndrome. All selected questions can be customised. 
  • Customise: CRF questions can be customised by selecting measurement units or answer options from predefined lists. This feature ensures that the CRF is tailored to specific needs, enhancing the precision and relevance of the data collected. 
  • Capture: BRIDGE generates a paper CRF and files for creating a REDCap database, including a data dictionary for the CRF and a project metadata XML file. The resulting REDCap database will have an ARC-schema structure. This means that when you use BRIDGE for CRF generation, your database will be coded in the same standard as the ISARIC databases and all other partners using the tools. We believe this is very important, as it facilitates aggregated or federated analytics across standardised databases. 

For more information about BRIDGE, please visit the ISARICResearch GitHub repository for BRIDGE. You can find instructions about how to use BRIDGE in our Getting started with BRIDGE Guide. BRIDGE is a web-based application and ISARIC hosts a live version of this using the current version of the codebase.

If you encounter any issues to ARC or BRIDGE or would like to contribute improvements, please submit an issue on the BRIDGE repository or email us at: data@isaric.org. 

BRIDGE app

ISARICResearch GitHub – BRIDGE

ISARICResearch GitHub – BRIDGE Submitting an issue

Getting started with BRIDGE Guide

ARChetype CRFs and the library of Templates

ISARIC works closely with experts around the world to create CRFs for priority emerging and infectious diseases, such as mpox, Dengue, COVID and H5Nx, and for priority outbreak-related syndromes. These CRFs address key clinical research questions that can improve patient outcomes. We call these ARChetype CRFs.

ARChetype CRFs are an important subset of our library of Templates. Templates are sets of ARC questions that we have curated for other outbreak-related contexts, such as clinical severity scores and core outcome sets. The library of Templates is openly available for use and adaptation by the research community. We are continuing the development of new Templates and we will continue to add these to our platform in due course. More information about how to download an ARChetype CRF, including an up-to-date list of the ARChetype CRFs that are available, can be found in our Downloading an ARChetype CRF Guide.

Downloading an ARChetype CRF Guide