An international medical organization with headquarters in the United States (US) and branches in France wants to test a drug in both countries. What is the organization allowed to do with the test…

Question

Options

• AAggregate it into one database in the US
• BProcess it in the US, but store the information in France
• CShare it with a third party
• DAnonymize it and process it in the US

• A
  5% (3)
• B
  2% (1)
• C
  84% (48)
• D
  9% (5)

Explanation

Sharing test subject data with a third party (C) is permissible in international clinical research, provided proper consent and data-sharing agreements are in place - this is standard practice for sharing with regulatory bodies (like the FDA or EMA), ethics committees, or contract research organizations (CROs) overseeing trial integrity.

Why the distractors fail:

• A is wrong because France is an EU member state, meaning participant data is subject to GDPR; simply aggregating French participants' identifiable data into a US database violates GDPR's cross-border transfer restrictions.
• B is wrong because processing EU health data in the US - even with storage in France - still triggers GDPR's data transfer rules, which require more than just keeping a copy in the EU.
• D is wrong because clinical trial data must often remain identifiable for safety follow-up and regulatory inspection; true anonymization is extremely difficult to achieve under GDPR's strict standard, and anonymized data cannot support patient-level safety monitoring.

Memory tip: In international drug trials, data flows - to regulators, ethics boards, and sponsors - but it cannot freely leave the EU without protections. Think: "Share with oversight = OK; ship to the US = GDPR problem."

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