CORE Reference Statement on TransCelerate December 2019 CSR Template

In August 2019, the CORE Reference development team (Budapest Working Group, BWG) published a paper titled: 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. Our paper includes a detailed assessment of TransCelerate's November 18 CSR template in the form of an 'Additional File' comprising a 44-page replica of their template marked up with our 69 consolidated comments.

In December 2019, TransCelerate released updated versions of their CSR template and SAP template (referred to as 'assets'). These new assets and supporting resources reside at a new page location (this relocation of assets has taken place since the publication of our paper). To download the assets, you need to complete an online form.

The December 2019 TransCelerate CSR template is supported by a slide deck titled 'Summary of Changes in 2019 Release'. This 40 slide deck includes a rationale for each change. From Slide 25 or thereabouts, the rationale for change frequently includes 'Feedback from CORE review' or 'CORE feedback'. TransCelerate notes that this new release brings their template into “alignment with CORE”; however, there are no specifics provided as to how comprehensively the CORE feedback was addressed and incorporated.

TransCelerate have not made any contact with the BWG. The BWG have not reviewed the December 2019 TransCelerate CSR template.

Dr Sam Hamilton and Dr Art Gertel

Chair and Strategist for the CORE Reference Project and the Budapest Working Group (BWG)