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.

CORE Reference comprises the following, distinguished from one another through the use of shading:

Rationale comments are used for clarification purposes.

A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is provided.

 

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