Anonymised Vs Pseudonymised Trial Data

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    For the purposes of a data sharing agreement we are seeking to clarify whether our clinical trial data containing a trial number for each participant record is truly anonymised or just pseudonymised.

    Within our CTU we had believed that our trial data was pseudonymised as it can be re-identified by the “key” held at each site identifying a patient for each trial number. Our IG team within our larger organisation tells us that it is in fact anonymised since as the data controllers we do not hold that key so cannot ourselves re-identify the participants.

    What stance do others take please and what is your rationale?

    Thank you

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