Clinical Characterisation Protocol
Preparedness for future outbreacks
The Clinical Characterisation Protocol (CCP) is a framework designed to allow research teams to prepare by establishing necessary approvals, data collection methods, and sampling protocols before any disease outbreak occurs. This proactive approach removes delays, enabling a swift response as soon as a new threat arises.
Global consensus
The protocol has been developed through a global consensus by ISARIC members and approved by the World Health Organization (WHO).
Governance and data control
Investigators retain full control over the data and samples they collect. The protocol ensures that decision-making remains in the hands of local teams, while still promoting international collaboration and data sharing when appropriate.
Adaptability to local needs
The CCP is highly adaptable, allowing research activities to be tailored to meet current scientific priorities and local resource availability. Modular case report forms and flexible sampling schedules ensure that the protocol can fit the specific needs of each outbreak scenario. Researchers can collect data in real-time or retrospectively, depending on the situation.
International harmonisation
The CCP promotes global harmonisation of research efforts, enabling cross-border collaboration and comparative analyses. By aligning research protocols and using standardised tools, the CCP facilitates more effective and meaningful data sharing, helping to build a global understanding of emerging diseases.
Download the CCP Protocol
Implemented since 2012
The CCP has been in use globally since its first release in 2012. It played a pivotal role in the initial clinical characterisation of the novel coronavirus during the outbreak in Wuhan in 2020. In collaboration with its sister study, GenOMICC, the CCP was instrumental in 2020 in identifying a genetic variant (TYK2) that directly led to the development of a new, effective treatment for COVID-19: baricitinib.
Beyond COVID-19, the CCP has supported research on various infectious diseases and outbreaks, including H5N1 influenza, MERS, Ebola, Zika, tick-borne encephalitis virus (TBEV), Mpox, and numerous other public health threats worldwide.
How to implement the CCP
The primary principle of the CCP is to serve as a generic pre-approval protocol that individual nations, regions, or hospitals can establish during peacetime.
As an example, the generic CCP has been implemented in the UK since 2014 under the name ISARIC4C (Comprehensive Clinical Characterisation Collaboration).
This framework allows the activation of specific response modules tailored to the disease in question when an outbreak occurs.
Visit the CCP Specific Diseases pages :
We ask that ISARIC is acknowledged and informed if you implement the protocol.
Ethical approval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators.
Standardised tools
To support CCP data collection and analysis, the ISARIC Clinical Epidemiology Platform is designed to support research and facilitate global collaboration by providing a suite of openly-available, standardised tools. This platform offers tools that provide disease-specific Case Report Forms (CRFs), launch a database, and perform statistical analysis on the data you collect.
All these resources are free to use, and ISARIC can assist in their implementation and setup.
Researchers retain control over the data and samples they collect.
If you are interested in using or developing this protocol for global use, please contact data@isaric.org