Publications

Lee ZY, McIntosh A, Fagan V, Hamilton S. Celebrating 10 Years of the CORE Reference Project. AMWA Journal 2026; 41(3). (Open access article).

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

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. Medical Writing. 2024;33(3):38–45. DOI: 10.56012/rnqo6114

Researchers who plan to reuse these data should direct message us on LinkedIn 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.

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/

Mackinnon J, Hamilton S (Aug 2026). 2026 Joint Summary from the CORE Reference Project & Protocol Development: Helping Regulatory Medical Writers keep up with Modern Clinical Trials [Joint summary | Recording]

The CORE Reference Team (Jul 2026). Webinar: CORE -Value for the Global Regulatory MW Community: An Evergreen User Manual & CPD for Self-led Learning, 28 Jul 26 [Slide deck | Recording]

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

Lee ZY, McIntosh A, Vasey R (08 May 2026). Live Meeting. ‘How CORE Reference Advances Global Consistency in the Next Era of CSR Writing’ [Slide Deck]

Fagan V, Jordan D,  Burridge P (06 May 2026). Live Meeting: ‘Celebrating a Decade of CORE Reference: Still Powering Quality CSRs Today’ [Slide Deck]

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 (Jun 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 ]

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

Ebina H, et al. (2016): Poster P-11: CORE Reference guidelines for Japanese biopharmaceutical companies. Tokyo, Japan.
Download poster

Radkova E. (2016): Presentation at OCT IV Annual Conference, Moscow, Russia.
Download presentation