CSL Ltd Annual Report 2019

15 Clinical trials in process and new In 2018/19, CSL had 34 clinical trials in operation across all therapeutic areas. Of those, three had a first patient enrolled in the trial during the year. CSL conducts ethical clinical trials and adheres to exemplary standards of integrity in the formulation, conduct and reporting of scientific research. This is based upon three primary elements: scientific integrity, patient safety and investigator objectivity. The CSL Clinical Quality Management System allows us to monitor and effectively oversee the quality of our clinical trials and includes all good clinical practice (GCP), pharmacovigilance (PV), good laboratory practice (GLP), and good research laboratory practice (GRLP) audits. In addition, 10 (three CSL Behring and seven for Seqirus) inspections were undertaken by regulatory agencies such as the US FDA, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) and the Paul Ehrlich Institute (PEI). All inspections confirmed adherence with GCP requirements, validated the data integrity of our clinical trials and had no impact on clinical trial licences or operations. Clinical trial transparency Over the reporting period, 10 clinical trial registrations and 17 clinical trial results were published and made readily available to stakeholders and the general public. These were all disclosed in a timely manner and in compliance with our transparency policy. Our policy reflects international requirements and standards including requirements from the International Committee of Medical Journal Editors , WHO guidance and legislative requirements. 34 clinical trials in operation across all therapeutic areas. 10 regulatory inspections with no impact to clinical trial licences. CSL Limited Annual Report 2019 18 Powered by Innovation