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), Raquel Billiones, Zuo Yen Lee, Vivien Fagan, and Alison McIntosh. - provide Continuous Professional Development (CPD) resources 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...
Useful links mentioned in the video are:
CORE Reference website
CORE Reference manual
Mapping Tool
Launch paper
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