LITHUANIA: Lithuanian Bioethics Committee issues guidelines on clinical research under COVID-19
UPDATE ON March 23, 2020
Lithuanian Bioethics Committee issued guidelines on clinical research under COVID-19. However, further guidance is expected to be soon released by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania.
Meditrial manages several studies in Lithuania and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Lithuanian Bioethics Committee prioritizes any application or correction of clinical trial protocol related to COVID-19. Any documents should be submitted through the Electronic Government Gate or by email to lbek@bioetika.sam.lt. Clinical trial counseling is available on the phone tel. 8 5 261 0632.
Monitoring visits can be replaced with remote data review via phone or another telecommunication.
For more details, please see the English translation of the official communication in the attached document.
March 23rd, 2020: Lithuanian Bioethics Committee updates guideline.
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
Contact Meditrial for immediate assistance in Europe or the US.
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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.
