Guidance for CEPI Developers

This SPEAC deliverable summarizes Brighton Collaboration guidance on the collection,
interpretation analysis and presentation of safety data relevant for CEPI
candidate vaccine trials. Summary checklists are provided so CEPI developers
can check the degree to which their protocols and case report forms are
harmonized with published Brighton collaboration safety data guidelines for
vaccine pre- and post-licensure clinical trials including those for pregnant
women. It also includes sample AEFI CRFs, guidance on solicited local and
systemic reactogenicity and Tier 1 AESI.

Click here to download SO1_D2.7 Guidance for CEPI Developers_V2.0

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