AUSTRIA: BASG issues information on the withdrawal of measures for clinical trials at the end of the pandemic
The Austrian Federal Office for Safety in Health Care (BASG) updated its FAQ with new information related to the communication with the Federal Office and the withdrawal of measures at the end of the COVID-19 pandemic.
Communication with the Federal Office
All urgent measures taken to protect participants or safeguard the trial integrity required by the COVID-19 pandemic should be documented by the sponsor together with a justification and benefit/risk evaluation.
Changes with impact on participant safety or trial integrity (“substantial”) should be notified to the Federal Office as an urgent safety notification together with their implementation. A substantial amendment is not required.
For a notification only thereceipt by the BASG is confirmed. There is not authorisation and no publication on the BASG website.
Withdrawal of Measures
After the end of the pandemic situation or at the request of the Federal Office, a final summary report on all measures taken as a result of the pandemic situation should be submitted as a single substantial amendment.
This amendment also serves to formally conclude all changes made as an urgently required safety measure and to restore the study to its initial state, if possible.
For more details, please see the FAQ page from BASG.
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.
