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Celebrating 10 years of the CORE Reference Project

Authors: Alison McIntosh, Sam Hamilton

CORE Reference is a user manual, developed by the Budapest Working Group over the period 2014 to 2016, to help medical writers navigate relevant guidelines as they create clinical study report content relevant for today’s studies. CORE Reference (with its Preface) and the mapping tool constitute the user manual. In 2022, CORE Reference was designated an EMWA Special Project , and as such it has expanded to support the increased workload necessary for global surveillance of the regulatory reporting and public disclosure arena. To this end, the CORE Reference project now also provides a monthly, self-directed, continuing professional develop ment offering to the regulatory medical writing community. The user manual and the CPD offerings from CORE Reference are designed to help MWs build and maintain the critical knowledge and skills needed to effectively navigate the complex, evolving regulatory landscape. As the CORE Refer ence 10th anniversary approaches members of the current team Sam and Vivien reflect on the past, present and future of CORE Reference as it moves into a second decade.

Medical Writing. 2026;35(1):70-77. https://doi.org/10.56012/lxmo4674

© 2026 The Author(s)

Medical Writing. 2026;35(1):70–77 | https://doi.org/10.56012/lxmo4674

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