Phase I – First-in-Human Trials Learning Path

The Phase I – First-in-Human Trials Learning Path is designed to prepare professionals for the unique regulatory, ethical, and operational demands of early-phase clinical research. Covering ICH GCP (R3), principal investigator responsibilities, first-in-human study design, informed consent, randomisation and blinding, clinical site coordination, biological sample handling, and site-level quality management, this programme provides a structured foundation for everyone involved in Phase I unit operations and early-phase trial conduct.

Participants will develop an understanding of the specific safety, scientific, and regulatory requirements that govern first-in-human studies, including dose escalation design, stopping rules, risk mitigation strategies, and the critical site-level processes that protect participant safety and data integrity in the earliest and most sensitive phase of clinical development.

How this differs from the Phase II & III Learning Path

The Phase I – First-in-Human Trials Learning Path focuses on the early-phase environment — covering FIH-specific study design, single ascending dose and multiple ascending dose paradigms, Phase I unit operations, and the heightened safety oversight required in first-in-human research. It is designed for professionals entering or specialising in early-phase clinical research settings.

In comparison, the Phase II & III Learning Path addresses the broader operational and regulatory requirements for multi-site efficacy and pivotal trials — including protocol development, site selection, remote monitoring, trial master file management, and regulatory submissions. This learning path forms the essential bridge between preclinical findings and the pivotal evidence needed for regulatory approval.