Dear CDM community,
We understand you all are feeling the impact of COVID-19 personally and in your professional lives. Our clinical trials are not immune to this massive disruption. We understand Clinical trial teams actively are assessing the risks to their milestones and interruptions to the overall trial execution.
In this time of change, as the Data Management Leads and the stewards of good quality clinical data, we need to ensure the impact of COVID-19 on the data collection and management is methodically assessed. This is critical not only to safeguard Data Integrity, but more importantly ensuring the mitigations adopted by the teams also address the reliability of the data to make scientific conclusions at the end of the study. Patient safety is always at the top of what we do, it is even more important at this juncture.
Through this brief communication, we wanted to highlight the major risk-categories and the impact on the practices of clinical data collection and management due to COVID-19 as well as invite you to share your thoughts on the SCDM Community Platform . Data Managers should evaluate these areas working with the cross-functional Clinical Trial Team and be an active partner in developing specific mitigation strategies.