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

CORE Reference is a user manual to help medical writers navigate relevant guidelines as they create clinical study report (CSR) content relevant for today’s studies.

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CORE Reference was developed by the following EMWA and AMWA volunteers:

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