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. Data Managers should evaluate these areas working with the cross-functional Clinical Trial Team and be an active partner in developing specific mitigation strategies.
Risk-areas and potential impact to clinical data
Each of these risk-areas will require thoughtful mitigations, and in cases where (unfortunately), there are no good options, clinical trial may have to be extended out or additional patients may need to be recruited, or trial start-up delayed. In some cases, it may be required to put the clinical study on hold especially where the NME being studied uses immuno-suppressant mechanism given the spread of COVID-19. While each team or individual organization may decide on a strategy that is unique to their needs, we are pleased to share some high-level strategies to consider –
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Hope you find this information useful as you plan for specific mitigations in your respective clinical trials and assess the impact on clinical data integrity. We want to hear from you and invite you to share ideas and best practices: COVID-19 preparedness from a Clinical Data Management lens with your fellow SCDM members.
📣#CDMM Community,Join the conversation on Managing Clinical Data Quality during COVID-19 – Risks and Mitigation Strategies:-->COVID-19: Business Continuity Plans with Vendors
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📣#CDM Community, Join the conversation on Managing Clinical Data Quality during COVID-19 – Risks and Mitigation Strategies:
--> COVID-19: Managing Protocol Deviations
More info available here: https://community.scdm.org/scdm-connect