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