Problem statement
- The current ICH regulatory guidances for CSRs are the 1995 ICH E3 and the 2012 supplementary Q & A. The Q & A addresses some of the ambiguity inherent to ICH E3.
- All CSRs submitted in MAAs to EMA will be publicly disclosed. The associated risks are largely privacy-related. Minimising the risks is paramount.
Contribution of the CORE Reference project
CORE Reference is a user manual to help medical writers navigate relevant ICH, EU and US regional guidelines as they create CSR content for today’s studies, including detailed content suggestions and practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.
Abbreviations: CSR, clinical study report; EMA, European Medicines Agency; ICH, International Council for Harmonisation; MAA, marketing authorisation application; Q & A, Questions and Answers.
Process map of the CORE Reference project
Reproduced from the original publication under a Creative Commons licence: Creative Commons Attribution 4.0 International.
Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Shannon A, Gertel A, Budapest Working Group: Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trials transparency. Research Integrity and Peer Review. 2016.
Stakeholders
Stakeholders contributing to the development of CORE Reference included: Health Canada; Drug Information Association (DIA) Medical Writing Community’s CORE Review Task Force; Academic and Principal Investigator, Todd E. Pesavento, MD; and Patient Advocate, David Gilbert.
Abbreviations
AMWA: American Medical Writers Association
BWG: Budapest Working Group
CORE Reference: Clarity and Openness in Reporting: E3-based
EMWA: European Medical Writers Association
ICH: International Council for Harmonisation
ICH E3: ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. Step 4. 30 Nov 1995
ICH E3 2012 Q & A: ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1). 6 July 2012.
2014–2016 Budapest Working Group (BWG): Dr Sam Hamilton — Original Author and Chair; Vivien Fagan — Original Author and Committee; Dr Aaron B. Bernstein — Original Author; Tracy Farrow — Original Author; Dr Graham Blakey — Original Author; Debbie Jordan — Original Author; Dr Walter Seiler — Original Contributor; Anna Shannon — Original Contributor; Dr Art Gertel — Strategic Regulatory Advisor.
2016 Support: Dr Tania Kotsokechagia — Quality control (QC) and web design; Dr Katie Brooks — QC and Mapping Tool; Linda J Fraser — Mapping Tool; Amy Myers — QC; Dr Anna Ramirez-Soriano — QC.
News Summaries Support 2016–2025: Dr Raquel Billiones — Medical devices special interest.