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COVID-19 Risk Assessment of Clinical Trials: Medidata Guidance and Recommendations

COVID-19 Risk Assessment of Clinical Trials:

Medidata Guidance and Recommendations

As noted in COVID-19 and Clinical Trials: The Medidata Perspective, regulatory agencies world-wide have provided guidance on emergency measures to mitigate risks to clinical trial integrity and patient safety, with priority of these immediate activities given to the impact of the pandemic on the health and safety of the trial participant. This guidance has emphasized the importance of clinical trial sponsors assessing new and/or heightened risks posed by the  COVID-19 pandemic, and that these risks be mitigated appropriately.  

Global regulatory authorities* have introduced additional temporary flexibilities in clinical trials processes. The complimentary resources provided here contemplate the use of a risk-based approach to ensuring trial continuity while maintaining key principles such as:

  • Patient Safety
  • Data Integrity
  • Data Collection (Completeness)
  • Monitoring & Oversight

Risk Assessment and Guidance


Risk Assessment Template


* See applicable authorities’ posts for more detail- they are not uniform such as the US-FDA, EU-EMA, UK-MHRA, DE- BfarM, FR- ANSM, JP-PMDA, CA- HC, AU-DoH, SG-HSA (and more)