BWG Publications, Registration, Presentations and Publicity
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
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”
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.
Submitted 07 May 2019 to BioMedCentral's Research Integrity and Peer Review:
Review of the TransCelerate template for clinical study reports (CSRs) by the developers of CORE Reference (Clarity andOpenness in Reporting: E3-based). Hamilton S, Bernstein AB, Blakey G, Fagan F, Farrow T, Jordan D, Seiler W, Gertel A.
Watch this space for further updates about the progress of this publication.
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: firstname.lastname@example.org
The TransCelerate Biopharma Clinical Study Report template (November 2018 release) is available on the TransCelerate website under the Common Protocol Template resources.
ICH E3 and CORE Reference are confirmed as the two “well-known standards” used in TransCelerate’s CSR template development in this TransCelerate slide deck.
For further information, read the CORE Reference Press Release.
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.
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.