Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to outline procedures for aligning clinical trial registration with the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). It ensures transparency, ethical compliance, and accessibility of trial data to the global scientific community and public health stakeholders.
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The purpose of this SOP is to establish standardized procedures for the exchange of safety data with global pharmacovigilance (PV) systems, including VigiBase, the WHO global ICSR (Individual Case Safety Reports) database. This ensures international harmonization, timely reporting, and compliance with WHO pharmacovigilance expectations.
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The purpose of this SOP is to define structured community engagement practices for clinical trials conducted in low- and middle-income countries (LMICs). Community engagement ensures ethical trial conduct, cultural sensitivity, trust-building, and alignment with WHO expectations for equitable participation and transparency in clinical research.
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The purpose of this SOP is to define standardized procedures for conducting vaccine clinical trials in alignment with World Health Organization (WHO) Prequalification (PQ) guidance. Compliance with PQ ensures that vaccine data supports global procurement and use by United Nations agencies and Gavi, strengthening public health impact.
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The purpose of this SOP is to establish structured procedures for timely data sharing and transparency in clinical trials conducted during public health emergencies (e.g., pandemics, epidemics). It aligns with WHO guidance to ensure that trial results contribute rapidly to public health decision-making, while maintaining ethical and regulatory compliance.
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