BWG Publications, Registration, Presentations and Publicity

Publications

Lee ZY, McIntosh A, Fagan V, Hamilton S. The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community.  http://dx.doi.org/10.56012/rnqo6114

Data availability statement: The 2023 Utility Survey questionnaire is appended at the end of this article. Raw data are available to download from the link below.

CORE Reference 2023 utility response data.

Researchers who plan to reuse these data should email contact@core-reference.org and provide a concept for data reuse and make reference to this article in any publication in which these data are used. Re-use of these data is by a priori written permission from CORE Reference.

Open Access Resource released 13th December 2022: CORE Reference Project Team Compare TransCelerate CPT (v009) and Draft ICH M11 Step 2 Templates: A Comparison of Level 2 Headings                                                                                                           ICH-M11-vs-TCel-CPT_by-CORE-Ref_13Dec2022
Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Gertel A, (the Budapest Working Group [BWG]). Critical Review of the TransCelerate Template for Clinical Study Reports (CSRs) and Publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table. Research Integrity and Peer Review. 2019.                                                                                          http://dx.doi.org/10.1186/s41073-019-0075-5

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.
http://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0009-4 and
http://dx.doi.org/10.1186/s41073-016-0009-4
Hamilton S, Seiler W, Gertel A: The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guidance with current practice and developing clinical study protocol guidance. Medical Writing 2014.
http://journal.emwa.org/post-approval-regulatory-writing/the-emwa-budapest-working-group-a-2-year-collaboration-to-make-recommendations-for-aligning-the-ich-e3-guideline-with-current-practice-and-developing-clinical-study-protocol-guidance/ and http://dx.doi.org/10.1179/2047480614Z.000000000254

Registration

CORE Reference is registered with http://www.equator-network.org as a 'reporting guideline’
http://www.equator-network.org/reporting-guidelines/core-reference/

Presentations

Gertel A, Hamilton S (planned presentation 08 May 2020, EMWA Prague conference cancelled). “Critical Review of the TransCelerate Template for Clinical Study Reports (CSRs) and Publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table”.
Critical Review T/Cel CSR Template [Slide Deck]
Gertel A, Hamilton S (planned presentation 07 May 2020, EMWA Prague conference cancelled). “Docket # FDA-2019-N-2012. New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication”.
Docket # FDA-2019-N-2012 [Slide Deck]
Gertel A, Hamilton S (10 May 2019). “CORE Reference 3 Years On - A Resource for Continuing Professional Development”. Presentation including news of BWG review of the TransCelerate CSR template presented at the Regulatory Expert Seminar Series at the EMWA Conference in Vienna
CORE Reference - Three Years On [Slide Deck]
Bernstein A, Gertel A (26 June 2017). “The Core Reference Open Session” presented at the AMWA Conference in Rockville, Maryland, USA.
Ebina H, Fagan V, Gertel A (22 June 2017). Presentation (intermediate level session) at Drug Information Association (DIA) Annual Conference in Chicago, USA. "Driving International Awareness and Use of Regulatory Writing Guidelines: Case Studies of the Clarity and Openness in Reporting (CORE) Reference Guidelines". CORE Reference awareness: DIA 2017 [Slide Deck]
Hamilton S, Farrow T (04 May 2017). Presentation including Utility Survey Results. 5th EMWA Symposium, Birmingham, England.
CORE Reference - One Year On [Slide Deck]CORE Reference - One Year On [Symposium Report and Utility Survey Results]
Hamilton S (01 March 2017). “CORE Reference” [Half day presentation to The Danish Medical Writers Network, hosted by Leo Pharma in Copenhagen]
Bernstein A, Gertel A (15 February 2017). [Webinar]
“CORE Reference: ICH E3 for Dummies: A Users Guide to ICH E3, privacy, disclosure, transparency, and applied value in the preparation of clinical study reports”
Bernstein A. (2016, July 17). CORE Reference: A Medical Writer’s Guide to Preparing CSRs in an Evolving Context [Webinar]. American Medical Writers Association Online Learning.
http://amwa.mycrowdwisdom.com/diweb/catalog/item/id/1165151/q/o=-d&c=185

In order to view the video, an AMWA login will need to be created. This is a free registration process for those who are not, or do not wish to become, AMWA members.

Hamilton S. Presentation. CORE Reference launch. Update to EMWA Conference, Munich. 12 May 2016
https://vimeo.com/167275242
Hamilton S, Farrow T, Fagan V, Gertel A, Blakey G. Presentation. CORE Reference. Project Update to EMWA Conference, The Hague. 06 November 2015.
https://vimeo.com/145279503
Gertel A, Bernstein A, Hamilton S. Presentation. CORE Reference. Project Update to EMWA Conference, Dublin. 06 May 2015.
https://vimeo.com/127467647

Publicity

Hamilton S, Jordan D. ‘CORE Reference - a tool for modern clinical study reports in an era of increasing transparency and disclosure’. Medical Writing 2018;27(2):64-67.
http://journal.emwa.org/public-disclosure/core-reference-a-tool-for-modern-clinical-study-reports-in-an-era-of-increasing-transparency-and-disclosure/
Hamilton S, Forjanic Klapproth J. ‘Streamlining clinical study protocols and reports’. Medical Writing: The Backbone of Clinical Development, Special Edition 2017: 28-31.http://viewer.zmags.com/publication/ad20d93c#/ad20d93c/13
PDF Downloadhttp://www.core-reference.org/media/1045/a-new-standard-for-medical-writing_sam-hamilton-and-julia-forjanic-klapproth_clinical-trials-insight_final.pdf
Sam Hamilton's BioMed Central Guest Blog ’Safeguarding the privacy of clinical trial patients’ 27 May 2016:
http://blogs.biomedcentral.com/on-medicine/2016/05/27/safeguarding-privacy-clinical-trial-patients/
Press release. CORE Reference launch. 03 May 2016
http://www.core-reference.org/media/1039/core-leaflet-a4.pdf
Press release. CORE Reference project plan. 28 January 2015
http://www.emwa.org/Documents/CORE%20Press%20Release-28jan15_final.pdf

Coming Soon

CORE Reference Webinar 

Keep a placeholder for Wednesday 04 December 2024, 12:30 - 13.45 CEST (11.30 - 12.45 UK time)

Title: EMA Policy 0070 Real Life Experience – Voydeya

Presenters: Raquel Billiones, PhD and Alison McIntosh, PhD for the CORE Reference Team 

Register here by emailing EMWA Head Office at membership@emwa.org.

The next CORE Reference webinar will focus on preparing an EMA Policy 0070 Anonymisation Report (AnR), using examples from the Voydeya submission completed in Spring 2024 and with clinical data published on 26 June 2024. Members of the CORE Reference team will discuss specific challenges presented by rare diseases, including selection of appropriate anonymisation methods and will outline some of the problems challenges this poses with maintaining data utility. The webinar will also cover interactions with the EMA and present some  lessons learned from the Voydeya anonymisation process.

This webinar will:

 

Previous related presentation: The CORE Reference webinar on 7 June 2024 included a general introduction to the Policy 0070 Anonymisation Report (AnR) Template. For details, see https://www.core-reference.org/media/1088/core-reference-seminar-emwa-valencia-may-2024-and-webinar-07-june-2024-slides.pdf (refer to webinar slides 21 – 37 or presentation video at 30 – 58 minutes).

Third-party Publications and Presentations

The BWG, the developers of CORE Reference are pleased to share the following third-party materials about CORE Reference. The BWG does not accept responsibility for the accuracy of third-party materials. If you have a third-party publication to share, please email: contact@core-reference.org

The TransCelerate Biopharma Clinical Study Report template (December 2019 release) is available on the TransCelerate website under:Clinical Content and Reuse Assets

ICH E3 and CORE Reference are the two “well-known standards” used in TransCelerate’s CSR template development in this TransCelerate slide deck.

Note: The developers of CORE Reference were not involved in TransCelerate’s CSR template development.

CORE Reference-related updates are now available in Japanese on a dedicated blog. Thank you to Yukie Uchiyama (responsible for Japanese writing of the blog) and Hiroko Ebina (responsible for quality assurance of the blog) for making this initiative possible.

Note: The opinions expressed in Yukie Uchiyama’s blog, and the interpretations of CORE Reference are solely those of the blogger, and are not necessarily those of the CORE Reference authors.

Ebina H, Homma Y, Woolley KL. Poster P-11 (English translation from the Japanese): CORE Reference: New guidelines of preparing clinical study reports for Japanese biopharmaceutical companies seeking international regulatory approvals. Presented at the 6th General Meeting for the Society of Regulatory Science of Medical Products. 9-10 September 2016, Tokyo, Japan.
http://www.core-reference.org/media/1044/ebina-homma-woolley_englishtranslation-japanposter-29aug16.pdf

Radkova E. Slide presentation. Clarity and Openness in Reporting: E3-based (CORE) Reference. OCT IV Annual Conference - Clinical Trials in and Outside Russia. 19 September 2016, Moscow, Russia.
http://www.core-reference.org/media/1043/eradkova-oct-conference-russia-19sep2016.pdf