Croatia (Hrvatska)

Country Analysis

1.
Are there specific legal requirements in Croatia-Hrvatska for a patient living in Croatia-Hrvatska who wants to participate in a clinical trial in another country?

No

2.
Are there specific legal requirements in Croatia-Hrvatska if an investigator wants to enroll a foreign patient in a clinical trial?

Not known

3.
Are there national health authority requirements in Croatia-Hrvatska for a patient living in Croatia-Hrvatska who wants to participate in a clinical trial in another country?

Not known

4.
Are there specific national health authority requirements in Croatia-Hrvatska if an investigator in Croatia-Hrvatska wants to enroll a patient living in another country in a clinical trial?
  • All ICFs would need to be reviewed and approved first by the Ethics committee, so if the ICF is in another language (other than Croatian) it would need to be submitted for approval to CEC and MoH.
  • Related to this subject - MoH issued a guidance on the inclusion of Ukrainian patients in the same studies in Croatia (ongoing patients from Ukraine transferring to Croatian sites, but for the same study) in 2022 that contain the above requirements.
5.
Are there specific ethics committee requirements in Croatia-Hrvatska for a patient living in Croatia-Hrvatska who wants to participate in a clinical trial in another country?

Not known

6.
Are there specific ethics committee requirements in Croatia-Hrvatska if an investigator in Croatia-Hrvatska wants to enroll a patient living in another country in a clinical trial?
  • For a patient to participate in a trial in Croatia, he/she would have to sign an ICF either in native language of the patient or an interpreter would need to be approved for use and such process documented in detail.
  • All ICFs would need to be reviewed and approved first by the Ethics committee, so if the ICF is in another language (other than Croatian) it would need to be submitted for approval to CEC and MoH.
  • In addition there is a requirement for drafting the updated Insurance Policy and the Contract with the site if applicable.
7.
Are there national health insurance rules or experiences in Croatia-Hrvatska concerning coverage of any additional costs for a patient living in Croatia-Hrvatska when participating in a trial in another country?

It is possible for subjects with dual citizenship who have also Croatian health insurance example: subjects from Bosnia and Herzegovina with Croatian citizenship and Croatian health insurance.

8.
Are there national health insurance rules or experiences in Croatia-Hrvatska concerning coverage of follow-on healthcare costs occurring after a patient has returned from participating in a clinical trial in another country?

Not known

9.
Are there national rules or experiences in Croatia-Hrvatska concerning additional costs (not covered by the trial sponsor) if an investigator wants to enroll a patient living in another country?

Not known

10.
Are there requirements for clinical trial liability insurance in Croatia-Hrvatska to cover the costs of trial associated damages occurring in the participating patient's home country?

Not known

11.
Are there any additional liability insurance requirements to join an ongoing trial in Croatia-Hrvatska from another country?

Not known

12.
From where do patients in Croatia-Hrvatska get information on clinical trials taking place in another country?


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13.
Did patients living in Croatia-Hrvatska get enrolled in a clinical trial in another country?


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14.
Did patients living in Croatia-Hrvatska experience challenges with getting their trial medication when they returned to their country of residence?


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15.
Did patients living in Croatia-Hrvatska experience challenges with continuation of their medical care after returning to their country of residence?


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16.
Did patients living in Croatia-Hrvatska experience challenges with coverage of their basic healthcare costs like hospital stay, baseline diagnostics or treatments, etc. when joining a clinical trial in another country?


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17.
Are there clinical investigators in Croatia-Hrvatska that accept trial participation of patients from another country?


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18.
Is there experience with transfer of medical information when a patient living in Croatia-Hrvatska wants to join a clinical trial in another country?


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19.
Are there clinical investigators in Croatia-Hrvatska who have experience with enrolling patients from another country?


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20.
Do treating physicians in Croatia-Hrvatska inform patients about the option to participate in a clinical trial in another country?


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