As part of the CSL Group, CSL Seqirus is committed to ensuring the transparency and public accessibility of information related to our global clinical research activities. This information enhances scientific exchange, and helps people to make informed decisions about potential influenza vaccine options as well as potential participation in clinical trials. CSL Seqirus makes every effort to comply with national and international standards relevant to clinical trial disclosure and data.

To this end, we are committed to:

• The prospective registration on a publicly available trial registry of all CSL Seqirus-sponsored clinical trials and applicable observational/non-interventional studies (NIS); and

• The reporting of results of completed CSL Seqirus-sponsored clinical trials and applicable observational studies/NIS on a results database or equivalent website, according to regulatory requirements. Results are made publically available, regardless of the outcome.

CSL Seqirus has a Quality Management System that consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical Development organization. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical Development ensuring regulated clinical trial activities are:

• Conducted with a high level of quality;
• Conducted according to regulatory requirements;
• Consistent with industry best practices.

These objectives are achieved through:

• Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
• A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
• A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned;
• Execution of audits on our investigative sites, vendors, and internal processes/systems.