As the COVID-19 emergency impacts all healthcare sectors, the FDA issues guidelines to help industry and researchers. Safeguard of patients’ safety is the key concern, but also avoiding the compromised integrity of important studies due to missing data and deviations from scientific protocols.
The FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.
With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions:
- 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
Contact Meditrial for immediate assistance in Europe or the US. Free Helpline +1-800-901-4286 helpline@meditrial.net
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