Medical Writing Public Disclosure Clinical trial results disclosure on and EudraCT

Volume 27, Issue 2 - Public Disclosure

Clinical trial results disclosure on and EudraCT


The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available data for a giventrial. Furthermore, differences exist in thespecific requirements for data disclosure onthe and European UnionDrug Regulating Authorities Clinical Trialsdatabases. The planning of disclosure ofclinical trial results must occur alongsidepreparation to author the Clinical StudyReport in order to meet this important legalobligation.

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  1. Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). Available from Available from:
  2. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Available from: Available from:
  3. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801). Available from: Available from:
  4. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Annals of Internal Medicine. Editorial published at on 6 June 2017. Available from: Available from: news-and-editorials/data_sharing_ june_2017.pdf.
  5. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. DeVito NJ, Bacon S, Goldacre B; EBM DataLab, University of Oxford. Available from: Available from:
  6. Clinical trial assignment request template letter and template instructions. Available from: result.html.
  7. Results Data Element Definitions for Interventional and Observational Studies. June 29, 2017. Available from: Available from:
  8. EMA Q&A – EudraCT Results training – session 16th December 2014. Available from: Available from:
  9. EMA EudraCT V9 Workshop – Managing users and prepare results in EudraCT, 15th November 2013. Q&A documents. Available from: Available from:
  10. EudraCT result related data Dictionary. Available from: Available from:
  11. Regulation (EC) No 1901/2006. Available from: Available from:
  12. Regulation (EC) No 1902/2006. Available from: Available from:
  13. Commission Guideline 2009/C28/01. Available from: Available from:
  14. PRS Results Schema. Available from: Available from:
  15. EudraCT XML schemas and documentation. Available from: Available from:



President’s Message
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 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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