Medical Writing Editing Anonymisation: A new challenge for medical writers

Volume 27, Issue 3 - Editing

Anonymisation: A new challenge for medical writers

Abstract

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission packages containing anonymised data submitted to the EMA as of March 2018 shows that the most frequent technique to anonymise data is redaction. This is typically performed after reports are submitted to the competent authorities. The study report team, through a strong cross-functional strategy, can reduce the anonymisation required after submission of the document by proactively reducing the use of unnecessary identifiers in the initial report drafts. Therefore, the challenge for medical writers is to become involved in the anonymisation strategy and the creation of a data anonymisation plan for the clinical documents from their initial stages, focusing on the balance between scientific value and risk of re-identification.

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References

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