As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have played this safe by using heavy content redaction (covering up identifying information with a blue box), but now EMA is encouraging anonymisation over redaction to help maximise data utility while simultaneously mitigating the risk of patient identification. (Anonymisation involves changing identifiers, but they are still readable, such as placing an age of 27 into a band of 20–29). This article explores the issues and considers companies’ options.
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