ISARIC is a community of research networks and individuals collaborating to provide a platform through which global, patient‐oriented clinical studies can be developed, executed and shared. ISARIC activities promote the standardisation and harmonisation of definitions, endpoints and data collection methods so that international results can be combined and compared.
Research protocols and data tools addressing the most important questions between and during epidemics and rapidly emerging public health threats have been designed to generate new knowledge, maximise the availability of clinical information, and thereby save lives. These tools are available for anyone to download and use at the links below.
Responsibility for ensuring ethical conduct of research undertaken using theses materials lies solely with investigators implementing studies at their site(s). This includes requirement to obtain all necessary ethical and governance approvals to conduct research. It is important to align the response to emerging infections with public health agencies. Please discuss the implementation of this protocol with your local agency, ensure that results of public health significance are reported and avoid duplication.
PROTOCOLS (& other study documents)
Protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, training materials and other research tools are available to support implementation of the research.
Clinical Characterisation Protocol - Created by ISARIC members in collaboration with the World Health Organisation (WHO), this protocol is a standardized observational study for the rapid, coordinated clinical investigation of patients of all ages with severe or potentially severe acute infections. Patients with a spectrum of emerging and unknown pathogens are eligible. This protocol has been designed to characterize host and pathogen features of the infection in order to inform identification, triage and treatment of the disease. The standardized design will maximize the likelihood that data and biological samples are prospectively and systematically collected and rapidly shared across many different settings globally. The protocol is designed to have some level of flexibility in order to ensure the broadest acceptance.
Developed as a collaboration between ISARIC and the WHO, these case report forms collect the most critical and informative data for emerging infections. Implementation of these forms will harmonize data collection methods, definitions and endpoints to deliver standardized data which can easily be aggregated, tabulated and analysed across many different settings globally. The forms are designed to offer flexibility to the investigators to ensure the most relevant implementation and the broadest acceptance.