CORE Reference

Download the user manual here:

CORE Reference

( 49498 downloads )
Mapping Tool
( 39982 downloads )

Permission is not required to use the open access resources: the CORE Reference Manual, and the CORE Reference Mapping Tool.

Suggested citation: EMWA/AMWA Budapest Working Group (03 May 2016). The CORE Reference Manual. Available at DOI: https://doi.org/10.56012/copjhc4062

Suggested citation: EMWA/AMWA Budapest Working Group (03 May 2016). The CORE Reference Mapping Tool. Available at DOI: https://doi.org/10.56012/coobim6228

Download the CORE Reference launch paper, intended to enhance the use, understanding and dissemination of CORE Reference, here:

Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Shannon A, Gertel A, 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 trials transparency. Research Integrity and Peer Review. 2016.

http://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0009-4

and

http://dx.doi.org/10.1186/s41073-016-0009-4

Download the PDF from: https://rdcu.be/6rbv

Download the 2019 resources here (reproduced under the terms of The Creative Commons Attribution License 4.0):

CORE Reference Terminology Table Version 2
( 2614 downloads )
The BWG's unabridged review of the TransCelerate CSR Template
( 5579 downloads )

Download the paper explaining the 2019 resources here:

Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Gertel A, (the Budapest Working Group [BWG]). Critical Review of the TransCelerate Template for Clinical Study Reports (CSRs) and Publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table. Research Integrity and Peer Review. 2019.

http://dx.doi.org/10.1186/s41073-019-0075-5

or

https://rdcu.be/bM7fH

All URLs in CORE Reference are functional at the time of publication. Use of web browsers that may not support URL functionality is outside the control of the authors of CORE Reference. For optimal navigation and viewing of CORE Reference and the Mapping Tool, download the documents onto a desktop or laptop computer with Adobe Acrobat Reader installed. The navigation and viewing experience cannot otherwise be guaranteed due to inherent variability in web browsers and software applications.

Your Perspective Matters

Open comment period - 03 May to 14 June 2016

Thank you for your comments on CORE Reference during the 6-week open comment period (03 May - 14 June 2016). Click here to see all your comments and our responses to them.

Please continue to support this initiative by telling us if you have adopted use of CORE Reference into your working procedures or Standard Operating Procedures on the Adoption and Use page.

Disclosure feedback

We are interested in hearing from you if you have submitted CSR(s) redacted for public disclosure to regulators, and in any feedback that you may have received. The submission of redacted CSRs is new to our industry and our collective understanding of best practice will develop over the coming months and years. The awareness comments included in CORE Reference to indicate ‘primary use CSR’ text portions that should be considered for disclosure impact in the ‘secondary use CSR’ represent our current awareness. With your help, we can refine these over time and with insights you share with us. Please contribute and share your knowledge.

Disclosure feedback will be accepted on an open-ended basis via the Disclosure Feedback page.

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Keeping CORE Reference up to date

To maintain its relevance, surveillance of the regulatory and public disclosure landscapes will support periodic update of CORE Reference.