42 2021 ESG Report Appendices Transparency Healthy workforce and communities Responsible supply chain Climate change Introduction Product impact Medical Safety Officers in the Global Medical Safety and Governance Organization are in place to work closely with Medical Safety Specialists (MSS) in each Medical Affairs business team and with each Medical Affairs regional team. This process provides an independent but shared accountability model for medical safety. The Medical Affairs Safety Council (MASC) was established in FY 2020 as a forum that could be used for specific issues that would benefit from an independent medical review. The MASC is led by the VP of Global Medical Safety and Governance (GMS&G) and includes the EVP and chief medical officer along with the VP of Medical Affairs from each business unit. The MASC provides a mechanism for regular as well as ad hoc independent medical and/or product safety reviews or escalations related to Business Unit or Regional Medical Affairs organizations. Global clinical affairs Clinical studies are carried out by a central function within Medical Affairs, serving all BD businesses and regions. The vice president of global clinical affairs (VP GCA) reports directly to the company’s executive vice president and chief medical officer and has overall responsibility for clinical studies. The VP GCA is responsible for ensuring that clinical studies are carried out in an ethical manner and in adherence to good clinical practice (GCP). In addition, an independent Ethics Committee/Institutional Review Board (EC/IRB) reviews all studies and has the authority to approve, modify or stop a study at any time. Prior to the start of each study, a risk assessment is carried out by the GCA study team and representatives from the Medical Affairs Quality team. The risk assessment is shared with the EC/IRB and any oversight bodies, such as a clinical event committee, and regulatory agencies where applicable. Identified risks are assessed during the study on an ongoing basis, by examination of adverse events or other factors. Free and informed consent is obtained from all study participants prior to the start of each study. Consent is obtained by the principal investigator of the study site and designees, as per site procedures. The names and contact information of the study site’s principal investigator and the EC/IRB are provided to each study participant in written form, usually by listing this information in the subject’s informed consent. Participants are encouraged to reach out to either of these contacts if they have questions or concerns about the study. Extensive training in BD policies related to human subject research and in GCA’s formal Quality System, consisting of standard operating procedures (SOPs) and work instructions, is required of all BD associates who engage in clinical study activities. This training occurs through course and procedure review via the BD online training system, as well as through direct education during study team meetings. BD clinical studies are conducted in various regions by ethical and competent clinical research teams. The Medical Affairs and GCA teams have decision-making responsibilities in this area. However, the locations of the teams may vary from where products are ultimately marketed. In accordance with the GCA’s SOPs, a formal monitoring plan is written for each study. This plan defines the method and timing by which BD associates maintain oversight of each study site. Clinical study monitoring may occur through frequent communications via phone and email, and multiple visits to the site. The site and its principal investigator are qualified for participation by GCA procedures. Compliance to the study protocol and GCP, especially when related to safety issues, is reviewed regularly through the medical record and study database for each site participant. In addition, external audits are conducted using selected high-risk studies by BD auditors external to the GCA team. All studies are registered in public databases (such as clinicaltrials.gov ) as required by U.S. federal law. This includes information about the study protocol, clinical study sites and, eventually, adverse events and other study results. Reporting on significant problems discovered during monitoring, deviations to the protocol and necessary corrective actions are reported to the responsible EC/IRB and, when required, to the regulatory agency with jurisdiction (e.g., FDA). We are committed to seeking the publication of the results of our completed applicable clinical trials on any marketed product in peer-reviewed scientific literature, regardless of the trial’s outcome. We will provide the final statistical reports of protocol-derived outcomes to external authors. As a study sponsor, BD does not approve or veto such publications. View our clinical trial publication policy . In 2021 and early 2022, we announced the publication of a number of clinical trials, including: A first-of-its-kind, randomized clinical trial published in The Lancet Infectious Diseases that outlines potential new standard-setting best practices for peripheral IV catheters. (February 2) The first-ever peer-reviewed study evaluating the outcomes using midline catheters for blood collection published in the Journal of the Association for Vascular Access . The study evaluated the BD PowerGlide Pro™ Midline Catheter and showed that this option may reduce the need for direct venipuncture in patients who have midline catheters. Fewer needlesticks can reduce complications and lead to greater patient safety and satisfaction. Publication of the clinical trial results in Clinical and Translation Science for the BD Libertas™ Wearable Injector. The BD Libertas™ Subcutaneous Ready-to- use Injector is designed for drugs that have higher viscosities, such as biologics, and is currently in final phases of development. A peer-reviewed study published in the journal of Obstetrics & Gynecology showed molecular diagnostics could improve the accuracy of vaginitis diagnosis and lead to more appropriate and timely treatment decisions. Using real-world data, the study demonstrated the effectiveness of vaginal panels performed on the BD MAX™ Molecular Diagnostic System as compared to clinicians’ assessments.