What is CORE (Clarity and Openness in Reporting: E3-based) 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.

The Project Team - Sam Hamilton (Chair), Vivien Fagan, Alison McIntosh and Zuo Yen Lee - provide Continuous Professional Development (CPD) for medical writers through surveillance of regulatory reporting and public disclosure landscapes.

The CORE Reference Project was designated an EMWA Special Project in 2022.

Review the animation to find out more about how CORE Reference can help you...

CORE Reference was originally developed by the following EMWA and AMWA volunteers over the period 2014-2016:

De Novo Review Team

Medical Writing, Transparency
and Disclosure

Vivien Fagan

Sam Hamilton – Chair

Debbie Jordan

Statistics

Anna Shannon

Pharmacokinetics

Graham Blakey

Oversight Review Team

Aaron Bernstein

Tracy Farrow – special focus: public disclosure of clinical-regulatory documents

Art Gertel – special focus: project strategy

Walther Seiler

Quality Control

Tania Kotsokechagia