EU-X-CT - Borders Should no Longer be Barriers

Country Analysis

Are there specific legal requirements in Spain for a patient living in Spain who wants to participate in a clinical trial in another country?

Not known

Are there specific legal requirements in Spain if an investigator wants to enroll a foreign patient in a clinical trial?

Not known

Are there national health authority requirements in Spain for a patient living in Spain who wants to participate in a clinical trial in another country?

Not known

Are there specific national health authority requirements in Spain if an investigator in Spain wants to enroll a patient living in another country in a clinical trial?

All patient facing documents reviewed by Central EC are in Spanish language. If translation to another language for a foreign subject participation is needed the Central EC will not review/approve them. This is managed at site level only.

Are there specific ethics committee requirements in Spain for a patient living in Spain who wants to participate in a clinical trial in another country?

All patient facing documents must be translated into Spanish including the ICF. Reimbursement of expenses is mandatory including travel, meals and accommodation.

Are there specific ethics committee requirements in Spain if an investigator in Spain wants to enroll a patient living in another country in a clinical trial?

From the ethical perspective, all the patients have the same right whatever the country origin might be. Since there is not a local regulatory framework, the key points are the logistic aspects, and this is managed by the Sponsor and the site.

Are there national health insurance rules or experiences in Spain concerning coverage of any additional costs for a patient living in Spain when participating in a trial in another country?

In Spain, there is a general cover of health support for the population but that cover doesn´t apply to abroad patient (except when they are recognised as legal resident, ie Ukranian refugees).

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

Not known

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

All costs have to be assumed by the Sponsor.

10.

Are there requirements for clinical trial liability insurance in Spain 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 Spain from another country?

Not known

12.

From where do patients in Spain get information on clinical trials taking place in another country?

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13.

Did patients living in Spain get enrolled in a clinical trial in another country?

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14.

Did patients living in Spain experience challenges with getting their trial medication when they returned to their country of residence?

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15.

Did patients living in Spain experience challenges with continuation of their medical care after returning to their country of residence?

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16.

Did patients living in Spain 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 Spain 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 Spain wants to join a clinical trial in another country?

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19.

Are there clinical investigators in Spain who have experience with enrolling patients from another country?

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20.

Do treating physicians in Spain inform patients about the option to participate in a clinical trial in another country?

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