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Introduction This standardized Case Report Form (CRF) is the result of an ongoing effort between the World Health Organization (WHO), The Pan American Health Organization (PAH), Institute Pasteur
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Who needs controlled human infection models?

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Controlled human infection models (CHIMs) are experimental studies where healthy volunteers are intentionally exposed to a pathogen in a controlled environment to study the disease's progression and evaluate the efficacy of vaccines and treatments.
Researchers, clinical trial sponsors, and institutions conducting controlled human infection model studies are required to file for approval and adhere to regulatory requirements.
To fill out controlled human infection models, researchers must complete the necessary regulatory forms detailing the study design, risk assessment, informed consent processes, and protocols for monitoring participants.
The purpose of controlled human infection models is to provide valuable data on infectious diseases, improve vaccine development, and advance understanding of immune responses in a controlled setting.
Information that must be reported includes study objectives, methodology, participant selection criteria, safety monitoring protocols, and data management plans.
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