The TransCelerate common CSR template

This branch covers the common clinical study report template that TransCelerate BioPharma publishes, as a document the report's author works from. Its parts divide by the part of the report the template's instructions address, in the report's own order, after one part on the template as a whole: what it is, its releases, its core backbone and heading rules, the kinds of text it marks, the terminology it standardises and how far it binds. The ICH E3 guideline and the CORE Reference manual that the template draws on, where the template stands among the report's other sources of requirements, and what CORE Reference offers beside it are left to the branch's neighbours.

• What the common CSR template is and how an author works with it — the template as one of TransCelerate's common templates, its releases and the Budapest Working Group's review of the 2018 release, its core backbone with the headings that stay fixed and those an author may adapt, synoptic and abbreviated reports, the five kinds of text it marks, the terminology it standardises, its discretionary use, and its reminder that many regulators have begun to require more public disclosure of clinical trial documents.
• Template front matter and the synopsis — the title page, the compliance statement, an amended report's summary of changes, the stand-alone synopsis and its fields, the table of contents, and the abbreviations list.
• Reporting the plan under the template — the unnumbered ethics section and Sections 1 to 3, which direct the reader to the protocol and report what actually happened, what changed and what the study did about quality: the introduction, the objectives, endpoints and estimands, and the investigational plan through data quality assurance, quality tolerance limits and statistical considerations.
• Reporting the results under the common CSR template — Sections 4 to 7: the presentation rules for Sections 4 and 5, study participants, the evaluation of response to study intervention with its efficacy, safety and other analyses, the validity and limitations of the results, the conclusions, and the references.