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:
- ICH E3 guidance text is shown in unboxed grey shading.
- ICH E3 Question & Answer 2012-derived guidance text is shown in italics with grey shading and a boxed outline.
- CORE Reference text is not shaded and not boxed.
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
Sam Hamilton – Chair
Oversight Review Team
Tracy Farrow – special focus: public disclosure of clinical-regulatory documents
Art Gertel – special focus: project strategy