CORE Committee: Dr Sam Hamilton, Vivien Fagan, Dr Zuo Yen Lee, Dr Alison McIntosh.
What is CORE Reference?
CORE Reference is a user manual developed over the period 2014 to 2016 to help medical writers navigate relevant guidelines as they create clinical study report (CSR) content relevant for today’s studies.
CORE Reference is evergreen if augmented with an understanding of post-2016 changes in the clinical trials ecosystem. Whether you are developing a CSR for the first time or seeking to enhance consistency and transparency in your reporting, the CORE Reference resources should be a key part of your toolkit. Explore the website resources and follow subsequent updates on the LinkedIn page to keep current.
Aim of the CORE Reference Project
To provide Continuous Professional Development (CPD) for the regulatory medical writing community through open access resources and intelligence dissemination on clinical study reporting and public disclosure of clinical-regulatory documents.
Find your way around The CORE Reference Project website using the adjacent navigation menu. Access key project information, downloadable resources, supporting tools, publications, News Summaries, and learning materials from one central location.
Select a section to explore CORE Reference guidance, discover available resources, and keep up to date with the latest project developments.
- Designated an EMWA Special Project in 2022
- Registered with EQUATOR network in 2016 as a reporting guideline
- Initiated by the Budapest Working Group in 2014
- Included EMWA and AMWA experts in ICH E3, CSR templates, CSR authoring, and public disclosure of clinical-regulatory documents
- Two-year collaboration with stakeholders to review the ICH E3 and subsequent regional guidelines impacting CSRs
- Authoritative open access user’s guide to support the authoring of CSRs for interventional studies
- Addresses ambiguity in ICH E3 CSR guideline 1995, and E3(R1) 2012 Q&As
- Presents practical suggestions for developing CSRs
- Sectional mapping tool companion to ICH E3
- Not a template
- Ongoing surveillance of regulatory reporting and public disclosure landscapes; insights shared with the medical writing community
- To support authoring of disclosure-ready CSRs
- Help medical writers interpret ICH CSR authoring requirements
- Highlights privacy-related risks associated with published CSRs
- Aids understanding of public disclosure requirements for CSRs
- Offers sectional content suggestions but does not mandate a particular CSR structure
- Shares regular updates on regulatory reporting and public disclosure; Pre-2025 archive
- Downloadable open-access resource
- Mapping tool which maps CORE Reference sectional content to ICH E3
- Peer reviewed publication (2016)
- Self-led CPD archive
- LinkedIn updates on regulatory reporting and public disclosure
Access all listed resources by navigating the adjacent main website.
- Provides CPD for medical writers
- Self-led CPD archive
- LinkedIn updates on regulatory reporting and public disclosure
Navigate CORE Reference.