EMA updated the guidance on the management of clinical trials during COVID-19 pandemic
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic.
Version 3 published on 28 April 2020 provides additional clarification on:
- the distribution of medicines to trial participants. This takes into account social-distancing measures and possible limitations in trial site and hospital resources;
- the remote verification of source data (SDV) in the context of social distancing measures. This aims to facilitate activities that support the approval of COVID-19 and other life-saving medicines;
- notifying authorities of urgent actions taken to protect trial participants against an immediate hazard, or of other changes taken to support patient safety or data robustness.
For more details please see the original communication from the EMA.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
