Publications

Lee ZY, McIntosh A, Fagan V, Hamilton S. The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community. http://dx.doi.org/10.56012/rnqo6114

Researchers who plan to reuse these data should email contact@core-reference.org and provide a concept for data reuse and make reference to this article in any publication in which these data are used. Re-use of these data is by a priori written permission from CORE Reference.

McIntosh A et al. Celebrating 10 years of the CORE Reference Project. MEW 2026;35(1):70–77. (Open access article)

Hamilton S, et al. (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 Terminology Table. Research Integrity and Peer Review. 2019. (Open access article)

Hamilton S, et al. 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. (Open access article)

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. Medical Writing. 2014. (Open access article)

CORE Reference is registered with the EQUATOR Network as a ‘reporting guideline’:
http://www.equator-network.org/reporting-guidelines/core-reference/

Hamilton S and Roche M (Jun 2026). Webinar: ICH M11:an integrated and forward-looking CeSHarP perspective, 17 Jun 26, guest speaker Marcie Roche’.

Hamilton S and Miric M (Jan 2026). Webinar: ‘CTIS and Clinical Trial Transparency: Strategies, Challenges, and CRO Insights’. [ Slide Deck | Recording | Chat ]

McIntosh A and Olude O (Nov 2025). Webinar: ‘Statistical anonymization software for utility-preserving privacy protection’. [ Slide Deck | Recording ]

Hamilton S, Lee ZY and McIntosh A (May 2025). Live Meeting: Open ‘CORE Reference Learn and Share. Presentation on community engagement and EMA Policy 0070’. [ Slide Deck ]

Billiones R and McIntosh A (2024). CORE Reference Webinar: Voydeya – EMA Policy 0070 in rare disease. [ Slide Deck | Recording | Chat ]

Medical Writing (2018): ‘CORE Reference – a tool for modern clinical study reports’
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Special Edition 2017: ‘Streamlining clinical study protocols and reports’
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BioMed Central Blog (2016): ’Safeguarding the privacy of clinical trial patients’
View blog post

Coming Soon: At the May 2026 EMWA Conference in Barcelona, The CORE Reference Project will be celebrating its 10th birthday. Plans will be unveiled at the November 2025 EMWA Virtual Conference.

The BWG share the following third-party materials. The BWG does not accept responsibility for the accuracy of third-party materials.

TransCelerate Biopharma: CSR template (Dec 2019) is available on the TransCelerate website under Clinical Content and Reuse Assets. Note: CORE Reference authors were not involved in template development.

Ebina H, et al. (2016): Poster P-11: CORE Reference guidelines for Japanese biopharmaceutical companies. Tokyo, Japan.
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Radkova E. (2016): Presentation at OCT IV Annual Conference, Moscow, Russia.
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