Role of the Clinical Data Managers During the COVID-19 Pandemic: An Overview.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has significantly changed the implementation of clinical trials. A large focus has been directed on clinical trial design, timeline, and best practices. It has led clinical trial study teams to update the existing processes and perform a risk assessment to mitigate the impact of the COVID-19 pandemic according to ICH-GCP (Good Clinical Practice) requirements. Data management plays a crucial role in understanding the study team's needs and developing innovative solutions. The Clinical Data Manager (CDM) is a core clinical trial Study Team member, responsible for promptly collecting, managing, and delivering complete, highquality data. OBJECTIVE: The COVID-19 pandemic required the Clinical Data Manager (CDM) to respond to changing needs by adapting data collection tools, data review strategies, and data management processes to answer new questions and address new challenges. CDMs became responsible for identifying how the COVID-19 pandemic impacted current data management processes and documentation and implementing changes to reflect new ways of working. The present article reviews the impact of the COVID-19 pandemic on clinical trials and the solutions adopted by the Clinical Data manager. CONCLUSION: The collection of COVID-19-related data points provides a better understanding of patient safety during the pandemic and proactively fulfills the growing regulatory interests. Strategies and innovative solutions adopted by the Clinical Data Manager serve as guidance for the clinical research team during the crisis to make the trials more robust and patient-centered.