3 Key Takeaways from the EMA Clinical Trial Guidance Update

New version addresses remote source data verification amid the COVID-19 pandemic.

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In February, the European Medicines Agency (EMA) issued Version 4 of its Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic.

Here are three key quotes from the update on remote data verification in light of trial participant safety amid the pandemic. For the full guidance document, click here.

Remote source data verification

“In addition to the above mentioned, established methods (11.a-c), and taking into account the continuing nature of the COVID-19 pandemic and the need to ensure the quality of clinical trial data and to protect the rights, safety and well-being of the participants in the EU/EEA, remote source data verification (rSDV) can be justified in clinical trials."

Applicable scenarios

“Remote SDV may be considered for trials:

  • involving COVID-19 treatment or prevention;
  • investigating serious or life-threatening conditions;
  • where the absence of SDV for critical data may likely pose unacceptable risks to participants’ safety or the reliability/integrity of trial results;
  • involving particularly vulnerable participants such as children or those temporarily (e.g. trials in emergency situations) or permanently (e.g. trials in patients with advanced dementia) incapable of giving their informed consent or in pivotal trials.”

Data security

“Remote SDV should not be carried out if adequate data protection, including data security and protection of personal data even if pseudonymised, is not ensured. Refer to Annex 1 for controls that, where applicable, can protect trial participants’ rights while permitting remote SDV.”

(Annex 1 is a 2.5-page section on the protection of trial participants’ rights during remote source data verification.)

 

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