Research Governance for Health Systems Data (HSD) Trials 

About this course

This course provides an introduction to research governance for clinical trials using Health Systems Data (HSD), often referred to as data-enabled trials. It explains the key regulations and legislation that govern the use of health data, why these are important, and how they can be effectively implemented in practice. The course also draws on real examples of inspections and audits of data-enabled trials to highlight common challenges, lessons learned, and best practices for maintaining compliance and public trust.

Intended audience

This course will be of interest to anyone involved in the delivery or oversight of clinical trials that use Health Systems Data. It will be particularly relevant to Quality Assurance and Regulatory Affairs Managers, trial managers, data managers, clinical investigators, and other staff responsible for ensuring trials meet governance and data protection standards.