Critical review of the TransCelerate Template for clinical study reports (CSRs) and publication of Version 2 of the CORE Reference (larity and penness in eporting: 3-based) Terminology Table.

Background: CORE (larity and penness in eporting: 3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user's guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc.

Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency.

Background: Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation.