EMA publishes detailed guidance on anonymising clinical data

The European Medicines Agency (EMA) has published comprehensive guidelines for preparing anonymization reports for clinical data packages. This guidance aims to provide applicants and marketing authorisation holders with a structured methodology to adequately anonymize clinical data for publication, while ensuring both data protection and scientific integrity.

The anonymization report required by the EMA is a multi-part document that covers various aspects of the anonymization process. It starts with basic application information, followed by a detailed description of the anonymization methodology used. An important section is dedicated to identifying data variables, distinguishing between direct and indirect identifiers. Direct identifiers, such as names or patient numbers, usually require complete removal or replacement for anonymization, while indirect identifiers, such as age or gender, can often be distorted by less restrictive methods such as generalization or perturbation.

The risk assessment is a central part of the report. Here, applicants should prove that the risk of re-identification has been reduced to 9% or less. This threshold was set by the EMA as an appropriate compromise between data protection and data usability. In parallel, applicants must also assess the effects of anonymization on data usability. It is particularly important that critical variables, which are essential for scientific analysis, are retained as much as possible.

The guidance also allows deviations from the standard EMA guidelines, provided that they are adequately justified. This allows a certain amount of flexibility to meet the specific requirements of specific data sets. At the end of the report, formal confirmation of the accuracy and completeness of the information provided is required, which underlines the responsibility of applicants.

Through this detailed guidance, EMA aims to promote a consistent and transparent approach to anonymizing clinical data. This should not only ensure the privacy of study participants, but also provide the scientific community with valuable, usable data. Ultimately, this initiative aims to increase transparency in clinical research while maintaining the highest ethical standards when handling sensitive health data.

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Source and detailed information: https://www. ema. europa.eu/system/files/documents/other/anonymisation-form-instructions-en.pdf (delete space for link)

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