ESTONIA: Regulatory clarification for all concerned parties in clinical trials
The State Agency of Medicines issued a guideline on clinical trial management which is in effect until the end of the Emergency Situation, which was declared by the Government of Estonia until 1 May 2020.
Meditrial manages several studies in Estonia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
A temporary halt of recruitment to ongoing clinical trials or a temporary halt of ongoing studies should be considered. Trials that have been approved but have not yet started recruitment should be postponed.
All protocol deviations must be carefully documented.
General guidance:
In case a significant change in the study plan is required, the amendment in the form of a local or global sub-protocol or attachment to the existing protocol should be done. There is no need to update the entire protocol.
The State Agency of Medicines and the national ethics committees are prepared to accelerate the evaluation of these amendments.
All notifications to the State Agency of Medicines should be sent to trials@ravimiamet.ee and “COVID-19” should be written in the subject line.
Moreover, The State Agency of Medicines describes changes that require and does not require a substantial amendment.
Changes that require a substantial amendment:
- Changes to the frequency of study visits
- Before switching from face-to-face meetings to telemedicine, prior approval of a substantial amendment is necessary.
- Changes to assessment/measurement methodology – when possible trial subjects might temporarily take measures themselves (e.g. blood pressure, weight, temperature, etc.)
- The use of home health care
All the information about changes in the conduct of the clinical trial concerning COVID-19 can be found here.
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 or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
