ISARIC/WHO clinical characterization protocol (CCP) for severe emerging infections and syndromes

This protocol exists to make it as easy as possible for researchers and clinicians to prepare for future outbreaks and novel threats. By establishing necessary approvals, data and sampling infrastructure in advance of an outbreak, we can be ready to understand any new disease as quickly as possible. The CCP is the product of a global consensus and is intended to support public health responses by enabling rapid, coordinated data collection, and to obtain consent from patients for research investigations that would not otherwise be possible.

The CCP is a standardised protocol for the rapid, coordinated clinical investigation of severe or potentially severe illness caused by acute infections by emerging or high-consequence pathogens or other noxious exposures (e.g. chemicals, toxins or potentially harmful energy sources) of public health interest.

Patients with acute illness suspected to be caused by emerging and unknown pathogens or exposures are eligible for inclusion. The extent of research activity can be adapted to local capacity and the scientific and clinical need. This is reflected in the use of modular case report forms and sampling schedules. Data can be provided in real-time or entered retrospectively.