Czech Republic

There is currently no legal requirement in Czech Republic preventing Patients from participating in a clinical trial in another country.

In general, Czech Republic follows the Medicines Act and Regulation 536/2014, ICH E6 (R3) Good Clinical Practice which does not exclude the inclusion of patients living in another country in clinical trials, nor the transfer of a participant from a clinical trial site to a site in another country, if it is in the interest of the participant and, if he and the sponsor agree to this procedure. Therefore, in justified cases, this option can be used.

There is currently no legal requirement in Czech Republic preventing investigators from enrolling patients living in another country in their clinical trial.

However, there are requirements concerning liability insurance and health care coverage (see related section). 

In general, Czech Republic follows the Medicines Act and Regulation 536/2014, ICH E6 (R3) Good Clinical Practice which does not exclude the inclusion of patients living in another country in clinical trials, nor the transfer of a participant from a clinical trial site to a site in another country, if it is in the interest of the participant and, if he and the sponsor agree to this procedure. Therefore, in justified cases, this option can be used.

Informal guidance from SUKL:

• Informed Consent Form required in the patient’s mother tongue
• Source medical documents must be assured to be correct and accurate to avoid any risks – best practice according to Ministry of Health is to verify the patient’s medical condition by re-assessing it locally 
• Patient should not suffer reduced living standards and so should receive e.g. travel cost reimbursement, accommodation and subsistence. 

Ethic Committee approval required; details of funding, insurance coverage, and translation of patient-facing information into native language required before recruitment. Translators need to be available for visits at the site and remote visits. 

Study Participant should be accommodated at/near the trial site if necessary.

There are requirements concerning liability insurance and health care coverage (see related section). 

The Sponsor provides insurance coverage for the territory of the Czech Republic, Czech study centres/investigators, and “for all patients” participating in the clinical trial. The Sponsor would need to ensure that the CT Insurance covers also foreigners not only Czech citizens.

Anecdotally one sponsor was asked to cover additional costs such as adverse event-related medical care or long-term baseline medication in the patient’s home country between visits.

Coverage of trial costs abroad that are not covered by the Trial’s Sponsor

In the Czech Republic, Standard of Care (diagnostics and treatment) that is part of a clinical trial must be covered by the sponsor or the patient.

For patients living in another country, there might be additional needs and guarantee from the Sponsor for such cases and should be agreed with the trial site and with the patient including travel and other costs.

The eHealth Digital Service Infrastructure (eHDSI) is an infrastructure ensuring the continuity of care for European citizens while they are travelling abroad in the EU. This gives EU countries the possibility to exchange health data in a secure, efficient and interoperable way.