CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure

Abstract: CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within and between sponsors. The ever-burgeoning regulatory guidance document substructure contains content requirements mandated subsequent to the International Council for Harmonisation (ICH) E3 guidance that must be worked into CSRs; these are integrated into CORE Reference. It is also the only known freelyavailable resource that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure considerations. Two years on from its initial release in May 2016, the developers of CORE Reference review the growing utility of this important tool, and place it into the context of the current global era of increasing data transparency and disclosure, where policies and guidelines in development beyond European borders will further mandate carefully authored CSRs for sharing in a global public arena.

I am a freelance medical writer providing a range of writing services, primarily to the pharmaceutical industry. I am a post-doctoral virologist working in clinical research since 1994, and specialising in regulatory medical writing from 1999. In my last salaried position (to September 2006), I managed UK Medical Writing for the world’s fifth largest Contract Research Organisation.

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Sam Hamilton, PhD.