January 2019

TransCelerate’s Open Access Clinical Study Report (CSR) Template

In November 2018, TransCelerate Biopharma - an alliance among some of the world’s prominent biopharmaceutical organisations - released a clinical study report (CSR) template.

TransCelerate’s CSR template was developed using the two “well-known standards” - ICH E3 and CORE Reference (www.core-reference.org). The EMWA AMWA CORE Reference development team was not involved in the TransCelerate CSR template development work.

Read our Press Release on TransCelerate’s CSR template and use of CORE Reference in its development.

Dr Sam Hamilton - Chair, CORE Reference Project
EMWA Past President, EMWA Fellow; Director, Sam Hamilton Medical Writing Services Limited

Dr Art Gertel - Strategist, CORE Reference Project
EMWA Past President, EMWA Fellow; AMWA Past President, AMWA Fellow; Principal, MedSciCom, LLC

PhUSE White Paper: Clinical trial transparency and disclosure: A global view

This excellent PhUSE white paper provides a snapshot of the current clinical trial transparency and disclosure arena and is a treasure trove of relevant references, guidances and other resources. The paper was "developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure with special focus on individual study and submission-related requirements".

Impact of EMA Relocation to Amsterdam on RPD Activities

Read this 23-January-2019 update on EMA’s relocation to Amsterdam. Note that in Annex 1 - in which EMA summarise their prioritised continued work activities in the multiannual work programme, there is no listing for clinical trial public disclosure activities.