LATVIA: SAM recommendations to ensure continuity of clinical trials during pandemic
State Agency of Medicines (SAM) of Republic of Latvia issued guidelines on clinical research under COVID-19.
Meditrial manages several studies in Latvia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Any changes in the trial conduct in relation to COVID-19 should be reported to SAM. Every deviation from normal practice should be appropriately documented.
Any amendment of an urgent safety measure may be implemented without obtaining permission form the SAM, although it should be still reported.
SAM is committed to process any applications related to COVID-19 via fast-track procedure.
Patients visit should be reduced, conducted remotely or in different site whenever COVID-19 risk will arise. This may cause changes to the trial schedule.
Monitoring visits can be replaced with remote data review.
All the information about changes in the conduct of clinical trial in relation to COVID-19 can be found here.
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.
