How Clinlogix Data Management is ensuring patient safety, mitigating risk, and safeguarding data integrity during this challenging and unprecedented time:

Clinlogix Data Management are stewards of good quality clinical data.  We are working 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, to ensure the mitigations adopted 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 time. 

Clinlogix DM, as members of the Society of Clinical Data Management, are utilizing all available industry wide resources and guidance provided. We are specifically paying close attention to the major risk-categories outlined below and their impact to clinical data collection and management due to COVID-19. Our Data Management Leads are actively evaluating these areas working with their cross-functional Clinical Trial Team and are an active partner in developing specific mitigation strategies.

Risk-areas:

  1. Patients/Study participants unable to travel to study sites
  2. Site staff unable to commute to work
  3. CRAs unable to perform site visits
  4. Vendors (labs, ECG, Imaging, IXRS) face staff shortage or shutdowns

Potential Impacts to Clinical Data:

  1. Critical to summarize missing data
  2. Assessment procedures that cannot be done centrally
  3. Protocol Deviations
  4. RBM practices

Clinlogix Risk Mitigation Strategies*:

  1. Additional Customized Metric Reports – these reports will provide more in-depth insight into pertinent information such as missed patient visits and site data backlogs that could result from COVID-19.
  2. Summarizing and Tracking Metrics at an increased frequency (weekly vs monthly) – Clinical Trial Team members will have more timely information to make more proactive decisions.
  3. Delivering metric summaries to the extended Clinical Trial Teams, both internal and external – This will provide a central data repository for group assessments and increased transparency into current study status.
  4. Review of Data Management and Statistical Analysis Plans –  Per the new FDA guidance, if changes in the protocol will lead to amending data management and/or statistical analysis plans, the sponsor should consider doing so in consultation with the applicable FDA review division. Prior to locking the database, sponsors should address in the statistical analysis plan how protocol deviations related to COVID-19 will be handled for the pre-specified analyses.

*Mitigation strategies based on March 27, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

 

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