Medical Writing Public Disclosure Anonymisation reports from 2016 to 2017: A preliminary analysis
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Volume 27, Issue 2 - Public Disclosure

Anonymisation reports from 2016 to 2017: A preliminary analysis

Abstract

The anonymisation report (AR) is a new and  relatively unknown regulatory document,  submitted as part of the redacted package of  a marketing authorisation application under  the EMA Policy 0070. The report documents  the methodology of anonymisation in each  package and the rationale for these methods.  As of December 31, 2017, 64 ARs have been  published on the clinical data website of the  European Medicines Agency. A preliminary  high-level analysis of these reports was  performed, with the aim of gaining infor -  mation on the current industry practices in  anonymisation and AR preparation. After  excluding 12 ARs from packages that did not  contain protected personal data, 52 ARs were  analysed. Information on anonymisation  methodology, re-identification risk assess -  ment, data utility assessment, and use of  software is presented.    

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References

  1. European Medicines Agency. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (EMA Policy 0070). EMA/90915/2016. Version 1.0 (2 March 2016) Version 1.1 (16 December 2016), Version 1.2 (11 April 2017), Version 1.3 (20 September 2017). Available at: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/09/WC500235371.pdf
  2. Anonymisation Report. Procedure # EMEA/H/C/002345/II/0020. Version 29 August 2017. Published 04 October 2017 at Available from: https://clinicaldata.ema.europa.eu/
  3. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available at Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679&from=EN

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Editorial
President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
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CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
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