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Developing the Clarity and Openness in Reporting: E3-based (CORE) reference user manual for creation of clinical study reports in the era of clinical trial transparency

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting clinical study reports (CSRs).
Full bibliographic reference Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Shannon A, Gertel A and for the Budapest Working Group. Developing the Clarity and Openness in Reporting: E3-based (CORE) reference user manual for creation of clinical study reports in the era of clinical trial transparency. Res Integr Peer Rev. 2016;1(4).
Language English
Relevant URLs
(full-text if available)
The full-text of this reporting guideline is freely available from: http://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0009-4

The CORE Reference Manual and Mapping Tool can be downloaded from:
http://www.core-reference.org/core-reference/

 
Reporting guideline website URL http://​www.​core-reference.​org
Reporting guideline acronym CORE Reference
Study design Clinical trials, Experimental studies
Applies to the whole report or to individual sections of the report? Whole report
Additional information Additional documents prepared during the development of this guideline:

Hamilton, S, Seiler W, Gertel A. The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guidance with current practice and developing clinical study protocol guidance. Medical Writing 2014;23(4):281-288.  Link to paper

Press release dated 28 January 2015

CORE Reference BWG team members list

 
Record last updated on May 3, 2016

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Our full catalogue of reporting guidelines is available to download as a PDF: Reporting Guideline Catalogue May 2014.