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.

Background to CORE (Clarity and Openness in Reporting: E3-based) Reference

  • 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

What is CORE Reference?

  • 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

Why use CORE Reference?

  • To support authoring of disclosure-ready CSRs
  • Help MWs 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

CORE Reference Outputs

CORE Reference Keeps Medical Writers Informed

  • Provides CPD for medical writers
  • Subscribers receive regular CPD email with up to date information on regulatory reporting and public disclosure landscapes
  • Creates a growing CPD reference library

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Visit CORE Reference website for further information

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