Medical Writing Public Disclosure Preparing anonymisation reports in general and for an orphan drug in particular
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Volume 27, Issue 2 - Public Disclosure

Preparing anonymisation reports in general and for an orphan drug in particular

Abstract

In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and therebymade publicly available. Before the clinicalreports can be published, the applicant isrequired by legislation to protect personaldata to ensure individual clinical studyparticipants and other individuals involved inthe study are not identified. The applicant hasto describe how data protection of personaldata has been ensured in an anonymisationreport (AnR). This article describes the diff -er ent steps necessary to prepare an AnR ingeneral, a company’s first experience ofpreparing an AnR for an orphan drug, and thekey points learned from this experience.

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References

  1. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Available from: Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001799.jsp&mid=WC0b01ac0580b2f6ba
  2. European Medicines Agency website on Clinical data. Available from: Available from: https://clinicaldata.ema.europa.eu/web/cdp/home
  3. Billiones R. Anonymisation reports from 2016 to 2017: A preliminary analysis. Med Writ. 2018;27(4):22–6.
  4. Henriksen-Bulmer J, Sheridan J. Re-identification attacks – A systematic literature review. IJIM. 2016;36:1184–92.
  5. EMA Questions & Answers on the External Guidance of Policy 0070 on Clinical Data Publication (CDP). Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/04/WC500225881.pdf

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Articles

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
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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