Germany

Country Analysis

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

Patients are free to participate in clinical trials performed outside of Germany. No German specific requirements in the other country for such cases.

Follow-up visits and treatments done back in Germany may have to be approved by separate clinical trial authorization in Germany.

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

There is no law explicitly forbidding patients from another country to join a trial in in Germany therefore in principle it is possible as long as ethical and regulatory standards are fulfilled.

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

No requirements in Germany if a patient want to join a trial in another country.

4.
Are there specific national health authority requirements in Germany if an investigator in Germany wants to enroll a patient living in another country in a clinical trial?

No additional approval needed by national Health Authority if the trial is authorized in Germany. 

5.
Are there specific ethics committee requirements in Germany for a patient living in Germany who wants to participate in a clinical trial in another country?

No requirements in Germany if a patient want to join a trial in another country.

6.
Are there specific ethics committee requirements in Germany if an investigator in Germany wants to enroll a patient living in another country in a clinical trial?

As long as a patient is able to fully understand the content of the informed consent and fulfils the inclusion/exclusion criteria, it should be permissible for a non-German resident to participate in a trial.

Travel insurance (if taken out for the trial) should cover international travel in such cases.

Travel arrangements usually organized by 3rd party vendor (to ensure data protection) as a commercial sponsor usually covers travel costs

Different patient languages need to be considered (translator might be required during patient visits)

ICFs and other patient-facing materials (depending on the involved EC) might need translation to the patient´s mother tongue depending on the patient´s language skills.

If different languages (not German) are being used to inform patients the respective documentation needs to be submitted to EC (required documentation depended on involved EC, from Certificates of translation up to submission of all translated documents incl. translation of insurance documents)

7.
Are there national health insurance rules or experiences in Germany concerning coverage of any additional costs for a patient living in Germany when participating in a trial in another country?

Patients not included in the German healthcare system through the mandatory healthcare insurance and potentially a lack of access to historic health information (medical records) of the patient could cause issues at sites.

8.
Are there national health insurance rules or experiences in Germany 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 Germany concerning additional costs (not covered by the trial sponsor) if an investigator wants to enroll a patient living in another country?

Patients not included in the German healthcare system through the mandatory healthcare insurance and potentially a lack of access to historic health information (medical records) of the patient could cause issues at sites.

10.
Are there requirements for clinical trial liability insurance in Germany 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 Germany from another country?

Travel insurance (if taken out for the trial) should cover international travel in such cases.

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


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13.
Did patients living in Germany get enrolled in a clinical trial in another country?


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


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


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16.
Did patients living in Germany 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 Germany 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 Germany wants to join a clinical trial in another country?


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


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


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