Samples testing in US for EU regulatory

Dear forum,

I would like to ask you about the following:
- A clinical trial to evaluate a drug efficacy/safety is being conduted in the EU in different clinical sites. For patient inclusion, a genetic test should be conducted. The company would like to send the samples to the US where there is a CLIA accredited lab that uses a specific genetic test.

--> It is feasible to send the samples from EU to the US so that they can be tested/processed in the US?
--> Is there any GDPR/HIPAA requirement that could jeopardize this approach?

In the scenario where the samples can be sent to the US, would this be accepted by the EU regulatory authorities at the time of drug approval?

thanks
JM

#1) feasible? that a judgment or budgeting question I cant answer.

#2) GDPR? The US lab would be a data processor I imagine and the need for and disposition of their data after processing must be made clear. A DPIA is suggested.

Ed Panek said:

#1) feasible? that a judgment or budgeting question I cant answer.

#2) GDPR? The US lab would be a data processor I imagine and the need for and disposition of their data after processing must be made clear. A DPIA is suggested.

Data Protection Impact Assessment (DPIA) - GDPR.eu

How to conduct a Data Protection Impact Assessment (template included) A Data Protection Impact Assessment (DPIA) is required under the GDPR any time you begin a new project that...

gdpr.eu

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thank you!!! very helpful!! Apologies, by feasible I was refering if it will be accepted by the reg authorities that samples are shipped to the US if the trial is conducted in the EU and to support EU approval for the drug aspect

thank you!