New 2019 CORE Reference Open Access Publication
Clarity and Openness in Reporting: E3-based (CORE) Reference, developed by the Budapest Working Group (BWG), a partnership of AMWA and EMWA, is a user manual designed to help medical writers navigate relevant guidelines as they create clinical study report (CSR) content. CORE Reference was one of two principal sources used by TransCelerate BioPharma Inc., an alliance of biopharma companies, in the development of its CSR Template released in November 2018. A new CORE Reference open access publication, 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 was published in August 2019 in the BIOMED CENTRAL journal, Research Integrity and Peer Review:
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, PDF https://rdcu.be/bM7fH)
Key resources from this publication can be downloaded on the CORE Reference website (from https://core-reference.org/core-reference/) and include the BWG’s unabridged comments on the TransCelerate CSR Template and the CORE Reference Terminology Table Version 2.
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Dr Sam Hamilton and Dr Art Gertel
Respectively, Chair and Strategist for http://www.core-reference.org