Cohort event monitoring (CEM) Protocol Template for active safety surveillance after vaccination with mpox vaccines

Protocol template to be used as template for observational study protocols for Cohort event monitoring (CEM) for active safety surveillance after vaccination with mpox vaccines

How to use this template to develop a CEM study protocol

The protocol template should be completed by adapting it to the specific country(ies) and study population(s). The sections of the protocol template to be adapted have been marked with blue square brackets.

It is important also to note that the adult informed consent form (ICF) template, provided in this template, and the informed consent process must be adapted to local situations, local languages and special populations (e.g., minors, pregnant women, elderly individuals lacking full capacity, migrants, prisoners, sex workers) that require a tailored approach to consent. This includes possible surrogate decision- makers, such as parents or guardians foryoung children, or study advocates for inclusion of prisoners, or orphans and additional forms, such as assent forms, as well as tailoring to correspond to the study information provided to participants during the consent process.

All protocols developed using this template should be reviewed by the appropriate committee(s), including the relevant ethics committees and institutional review boards, at a national level, or at the level of the study sites, or at the institution of the sponsor, as required by applicable laws and regulation.