Medical Writing Public Disclosure CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
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Volume 27, Issue 2 - Public Disclosure

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure

Abstract

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within and between sponsors. The ever-burgeoning regulatory guidance document substructure contains content requirements mandated subsequent to the International Council for Harmonisation (ICH) E3 guidance that must be worked into CSRs; these are integrated into CORE Reference. It is also the only known freelyavailable resource that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure considerations. Two years on from its initial release in May 2016, the developers of CORE Reference review the growing utility of this important tool, and place it into the context of the current global era of increasing data transparency and disclosure, where policies and guidelines in development beyond European borders will further mandate carefully authored CSRs for sharing in a global public arena.

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References

  1. ICH Harmonised Tripartite Guideline: Structure and content of clinical study reports E3. Step 4. 1995. Available from: http://www.ich.org/products/guidelines/efficacy/article/%20efficacy-guidelines.html
  2. ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1) 6 July 2012. Available from: http://www.ich.org/products/guidelines/efficacy/article/%20efficacy-guidelines.html
  3. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Revision 3 – Adopted Guidance. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001799.jsp&mid=WC0b01ac0580b2f6ba
  4. Health Canada. Public release of clinical information - Draft guidance document Available from: https://www.canada.ca/en/health-canada/programs/consultation-public-release-clinical-information-drug-submissions-medical-device-applications/draft-guidance.html
  5. Health Canada. Public release of clinical information. 13 April 2018. Available from: https://www.canada.ca/en/healthcanada/ programs/consultation-publicrelease- clinical-information-drugsubmissions- medical-deviceapplications. html
  6. FDA Clinical Data Summary Pilot Program Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm589210.htm
  7. General Data Protection Regulation (GDPR) Portal Available from: https://www.eugdpr.org/eugdpr.org.html
  8. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679&qid=1490179745294&from=en
  9. 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. Available from: http://dx.doi.org/10.1186/s41073-016-0009-4
  10. EQUATOR Network. CORE Reference Tool (Clarity and Openness in Reporting: E3-based) Available from: http://www.equator-network.org/reporting-guidelines/core-reference/
  11. US Department of Health and Human Services. Final Rule. Clinical trials registration and results information sharing. Available from: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-22129.pdf

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