The standards a report follows

This branch covers the standards a clinical study report is written against. Its parts divide by standard: the ICH E3 guideline section by section, the CORE Reference manual that interprets E3 for report authors, and the TransCelerate common template. A first part sets out where the report's requirements come from across these standards, ICH E6(R3) and the format a receiving authority sets, and a last part covers why E3 and E6 came up for revision. It leaves producing the report against these standards to the branch on writing the report, when a shorter report is acceptable to the topic on full, abbreviated, synopsis and interim reports, what ICH E6(R3) makes each party answerable for beyond the report to good clinical practice and trial quality, what a protocol must contain to clinical study protocols, and how far any regulation, guidance or guideline binds a document to the regulatory framework.

• Where a clinical study report's requirements come from — what ICH E3 sets out and the trials it reaches, ICH E6(R3)'s definition of the report, the sponsor's reporting duties and the content it adds to the report, the discretionary TransCelerate template, and a receiving authority's own format and appendix requirements
• The ICH E3 guideline — how the guideline's sixteen sections and eight annexes fit together, how far its headings bind as guidance rather than a template, then each section in turn from the title page through the investigational plan and the efficacy and safety evaluation to the appendices, and how CORE Reference adapts several of them
• CORE Reference for clinical study reports — the open-access manual that interprets ICH E3 for report authors: what it consists of and why it was needed on top of E3, how far it binds the report, what it offers beside the TransCelerate template and other resources, its preface, terminology and comment boxes, its disclosure flags, the dated guidance its reference list draws on, and its annexes on statistical issues
• The TransCelerate common CSR template — the discretionary industry template: its releases and how far it binds, its core backbone and heading rules, synoptic and abbreviated reports, the five kinds of text it marks, the terminology it standardises, and its instructions for the front matter and synopsis, the plan and the results
• Revising ICH E3 and E6 — the gaps between and within the report and protocol guidelines and those a report inherits from its protocol, how needs and practice changed after the guidelines were issued, the updates to the guidance by 2014, the Budapest Working Group's review of both guidelines, and whether the report will get an M11 of its own