EditverseClinical study reports
ICH E3 study reports, protocols under ICH M11 and SPIRIT 2025, patient narratives, lay summaries and data-to-text quality control for sponsors and investigators.
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- Clinical study reports
CSR quality control: a data-to-text verification checklist
A five-pass quality control sequence for a clinical study report: outputs to in-text tables, tables to text, synopsis to body, cross-references and abbreviations, with a sign-off matrix and a findings log.
- Clinical study reports
Lay summaries of trial results under the EU Clinical Trials Regulation
The ten Annex V elements of Regulation (EU) No 536/2014, the one-year deadline, the readability targets in the EU expert group recommendations, and a CSR paragraph rewritten for lay readers.
- Clinical study reports
From CSR to primary manuscript: keeping the registry, the report and the paper consistent
A three-way check of the registry entry, the clinical study report and the manuscript for outcomes, analysis populations and numbers, mapped to CONSORT 2025, with a worked discrepancy log.
- Clinical study reports
Patient safety narratives: which cases need one and how to structure it
ICH E3 section 12.3.2 names three groups of cases that need a narrative. The criteria, the content list, a paragraph-by-paragraph template, the source data for each element and an illustrative narrative.
- Clinical study reports
SPIRIT 2025 for investigator-initiated trial protocols
The 34 SPIRIT 2025 items set out for an investigator-initiated trial: what is new or revised against SPIRIT 2013, what ethics committees and journals look for, and model wording for three items.
- Clinical study reports
ICH M11: what the harmonised protocol template changes for protocol authors
ICH M11 fixes the order and headings of an interventional trial protocol. The dates, the 14-section layout, the text conventions and a migration table from an older sponsor template.
- Clinical study reports
Full, abbreviated or synoptic CSR: choosing the report type
Which studies need a full ICH E3 report, which can be reported in abbreviated form or as a synopsis, what each format leaves out, and why the safety sections stay complete in all three.
- Clinical study reports
ICH E3 section by section, with the CORE Reference mapping
The 16 sections of an ICH E3 clinical study report: what each one holds, which source documents feed it, and how the 2012 Q&A and CORE Reference change the way authors apply it.