This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be communicated to authorities.
Topics covered: – Initiating new trials – Changes in ongoing trials – Risk assessment – Communication with authorities – Agreement with and communication to sites – Changes to informed consent – Changes in the distribution of the IMP – Changes to monitoring – Protocol deviations – Reimbursement of exceptional expenses – Initiation of new trials aiming to test new treatments for COVID-19.
In the EU, clinical trials are authorised and supervised at national level and local legislations take priority. Check the National Guidelines at forum.meditrial.net. Sponsors are advised to also check whether there might be specific national legislation and guidance in place to complement or in some cases to take priority over this new guidance.

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