Austrian Health Authority (BASG) issued recommendations on measures for patient safety and communication with the authority during COVID-19 emergency.
Meditrial manages several studies in Austria and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Sponsors should document any action taken to protect trial participants and notify the Federal Office via email. Moreover, a summary report of all taken measures should be submitted at the end of the pandemic as a single amendment.
All submissions should be done by email. Priority will be given to the COVID-19 related submissions
For more details, please see the BASG guidelines and FAQ.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct a 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, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
