The Government of Estonia has declared an Emergency Situation until 1 May, 2020 due to the pandemic of COVID-19.
The State Agency of Medicines (SAM) has issued a guidance document on the management of clinical trials in Estonia during the COVID-19 situation. The guidance is in effect until the end of the emergency situation and will be updated as the situation progresses.
Any reported changes to the trial conduct must be specific and applicable to Estonian study sites and Estonian trial subjects. General descriptions of possible measures that may or may not be used in Estonia are not accepted.
- Risk Assessment: Sponsors and Principal Investigators (PIs) should perform a risk assessment of each individual ongoing trial and should adopt measures to implement patient safety and data validity. Sponsors need to reassess the risk on a timely basis. Amendments to the trial if any need to be documented.
- Recruitment process: Postponement or temporary halt of recruitment to be considered. In certain cases, withdrawal of individual trial subjects may be an appropriate method of risk mitigation.
- Documentation: All protocol deviations must be carefully documented.
- Amendments: If substantial changes to the protocol are required on a temporary basis, annexures to the existing protocol may be provided instead of updating the entire protocol.
- Expedited review: The State Agency of Medicines and the national ethics committees will review the substantial amendments to the study plans in an expedited manner. All notifications to the State Agency of Medicines should be sent to [email protected] and “COVID-19″ should clearly be written in the subject line.
Changes that require a substantial amendment:
Major changes during the conduct of the study need to be documented and require prior approval from SAM. Once amendments are submitted, a review would be conducted in an expedited manner. These include changes to the frequency of visits, switching from face-to-face meetings to telemedicine, changes to assessment/measurement methodology, the use of home health care.
Changes that do not require a substantial amendment:
These changes during the conduct of the study can be incorporated and then notified to SAM via email along with justification as they do not require prior approval from SAM. It includes centralised source data verification, Transfer of IMP between investigational sites, Direct supply to patient of IMP/NIMP, Moving patients from one study site to another, Adding COVID-19 testing to study plan.
In addition, the guidance also explains the electronic procedure for handling the data and the use of electronic signature for informed consent