BWG Publications, Registration, Presentations and Publicity
Publications
http://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0009-4 and
http://dx.doi.org/10.1186/s41073-016-0009-4
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
http://www.equator-network.org/reporting-guidelines/core-reference/
Presentations
Critical Review T/Cel CSR Template [Slide Deck]
Docket # FDA-2019-N-2012 [Slide Deck]
CORE Reference - Three Years On [Slide Deck]
CORE Reference - One Year On [Slide Deck]CORE Reference - One Year On [Symposium Report and Utility Survey Results]
“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”
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.
https://vimeo.com/167275242
https://vimeo.com/145279503
https://vimeo.com/127467647
Publicity
http://journal.emwa.org/public-disclosure/core-reference-a-tool-for-modern-clinical-study-reports-in-an-era-of-increasing-transparency-and-disclosure/
http://edition.pagesuite-professional.co.uk/launch.aspx?eid=f6b80f6a-ddd6-4705-bc9a-8af003f96adb
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
http://blogs.biomedcentral.com/on-medicine/2016/05/27/safeguarding-privacy-clinical-trial-patients/
http://www.core-reference.org/media/1039/core-leaflet-a4.pdf
http://www.emwa.org/Documents/CORE%20Press%20Release-28jan15_final.pdf
Coming Soon
EMWA Virtual Conference May 2021.
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