ARChetype CRFs are standardized, disease or syndrom-specific CRFs developed by ISARIC. They are a key component of the ISARIC-WHO Clinical Characterisation Protocol (CCP) framework, which aims to enhance global preparedness and response to infectious disease outbreaks. These CRFs are designed to address key clinical research questions, facilitating the collection of high-quality, harmonized data across different regions and healthcare settings. By focusing on priority emerging and infectious diseases—such as mpox, Dengue, COVID-19, and H5Nx—and related syndromes, ARChetype CRFs support rapid, coordinated research efforts that can inform patient care and public health strategies.
ARChetype CRFs are designed to collect data on community or hospitalised patients in order to address key clinical research questions and inform better case management, contribute to the design of clinical trials, and guide public health interventions.
Existing and in‑development ARChetype CRFs are summarized in the table below, and the creation process is described afterward.
| ARChetype CRFs (Available and under creation ) |
Syndromic | Disease Specific |
|---|---|---|
| Respiratory Infections |
ARI Syndrome – Hospitalised Population 📄 + Pregnant Women and Children module |
Covid – Hospitalised patients 📄 H5Nx – Hospitalised patients 📄 |
| Haemorrhagic Febrile Infections (viral) | Viral Haemorrhagic Fever (VHF) – Hospitalised Population |
Dengue – Hospitalised patients 📄 Yellow Fever – Hospitalised patients |
| Arboviral Infections | Arbovirus – Community patients |
Oropouche – Hospitalised patients + Pregnant Women and Children module |
| Brain Infections | Encephalitis – Hospitalised Population | |
| Mucocutaneous Infections |
Mpox – Hospitalised Population 📄 + Pregnant Women and Children module |
|
| Sexual Transmitted Infections | Sexual Transmitted Infections |
Existing ARChetype CRFs are now available and ready to use on BRIDGE by clicking on the CRF icons 📄 above.
For instructions, see our guide to using ISARIC ARChetype CRFs in BRIDGE.
ISARIC can host and manage your data on the ISARIC REDCap system, which offers standardized, pre-built databases aligned with all ARChetype CRFs. Contact us at data@isaric.org.
The ISARIC-WHO Clinical Characterisation Protocol (CCP) framework is a global, inclusive initiative offering a comprehensive approach for the rapid and standardised characterisation of (re)emerging infectious diseases. Within this framework, ISARIC supports researchers by providing a suite of standardised tools, including protocols, ARChetype case report forms (CRFs), and a CRF generator ( BRIDGE ) that allows forms to be tailored to local needs while ensuring consistent data collection. These tools utilise uniform questions, choices, and terminology, ensuring machine-readable, high-quality data across studies. Moreover, ISARIC Clinical Epidemiology Platform offers resources for efficient data capture and management and has developed an automated pipeline that can generate dashboards and results, aiding in the analysis of data and dissemination of evidence.
Central coordination by ISARIC promotes streamlined communication and collaboration among researchers, enhancing the efficiency and effectiveness of research efforts. Researchers also benefit from the experience and expertise of a global network of ISARIC collaborators. This network facilitates coordinated research efforts and enhances the collective response to infectious disease outbreaks.
The ISARIC’s methodology for developing archetype CCP CRFs, emphasises essential stages from initial identification of the need, through to final release and establishment of ongoing feedback mechanisms.
Please note that the guidelines will be adapted to reflect the context of the epidemic and disease.
If you have any modifications to suggest for an existing CRF, or would like to know more about a CRF under development, please contact us at data@isaric.org.
Any ISARIC staff or research partner may propose the development of a new CRF. The justification, specific requirements, and objectives of the CRF can be proposed to the ISARIC CCP team at data@isaric.org.
Where the topic is outside of the scope of ISARIC’s activities, the CCP Coordinator will liaise with the ISARIC ARChetype CRFs Approvers Commmittee to obtain a decision on endorsement and progression of CRF development. They will consider (a) the public health impact of the disease/syndrome, (b) existing research efforts to address the objectives proposed, (c) engagement of appropriate stakeholders (d) ISARIC’s ability to add unique value to global evidence generation efforts through development of the CRF.
Note: activities 3-7 below may be initiated in parallel to the endorsement process to speed up the process in the event of an active outbreak.
The Initiator of the CRF oversees the creation process in collaboration with the CCP Coordinator. The final version of the CRF will then be approved by the ISARIC ARChetype CRFs Approvals Committee.
In consultation with the ISARIC ARChetype CRFs Approvals Committee, the CRF Initiator will identify relevant Stakeholders including subject matter experts, partners in affected regions, researchers who have published relevant literature on the disease, clinicians with patient management experience, data managers, related global health actors, and regulatory bodies who will be invited to provide input and ensure alignment with diverse requirements. The Initiator will identify a subset of Experts whose input would most benefit an early stage of CRF iteration and designate them as ‘Expert Reviewers’.
The Initiator, supported by the CCP Coordinator, reviews existing literature, clinical trials, and guidelines to inform CRF development.
The CCP Coordinator or their delegate will contact WHO to obtain a copy of any related WHO CRFs, then discuss how the CRF and research questions can support WHO’s related initiatives and what parties should be involved in its development. WHO feedback will be incorporated as much as possible by iteration of the required steps above or below.
Working with the relevant Experts Reviewers, the CRF Initiator will define the research questions to be addressed by the CRF and map the relevant variables needed to address these questions.
Using ISARIC BioResearch Integrated Data Tool Generator ( BRIDGE ), the Initiator will develop an initial version of the CRF incorporating identified data points and standardised variables from the ISARIC Analysis and Research Compendium ( ARC . Variables that do not have existing structures in ARC will be drafted by the CRF Initiator and relevant experts.
The first draft will be shared with Experts Reviewers via a shared web platform. Comments and edits will be invited during a review period defined by the Initiator, relative to the urgency of the need for the CRF. All reviewers will be invited to add their names to the reviewer list on the CRF for attribution of input.
If within CEPI's scope of interest, the CCP Coordinator or their delegate share a copy of the CRF to request review and the addition of any variables that are valuable to CEPI's activities.
On completion of the review period, the Initiator will review all Expert Reviewers comments and, in consultation with individuals they deem informative, take decisions to create a final first draft CRF. This version will be endorsed by the ISARIC Approvers comittee before progressing to the piloting.
A REDCap project will be set up by ISARIC to enable end-users or colleagues to enter data and identify any usability issues. Feedback on any issues or improvements needed will be collected and necessary adjustments made.
On completion of the piloting period, the feedback of the users are integrated and a final version of the CRF is created. This version will be endorsed by the ISARIC Approvers Committee.
The final version will be incorporated as an ARChetype CRF in BRIDGE and communicated via ISARIC communications channels including direct email to all contributing Stakeholders, as well as the newsletter.
Last update: