Clinical study reports

A clinical study report is the account of a medicine's trial, its conduct and its outcome, submitted to a regulator. This branch covers that report, and its parts divide by the aspect of the report the work is about: what it is made of, who it is written for, the standards it follows, the format a study is reported in and how it is written. It leaves the report of a device investigation to clinical investigations of medical devices, who is named as the report's author and who signs it to authorship and signature of regulatory documents, what the protocol behind the report must contain to clinical study protocols, quality tolerance limits to good clinical practice and trial quality, turning a report into a journal article to research manuscripts, and posting results and publishing the report to transparency and disclosure.

• What a clinical study report is made of — the core report and its appendices, the supportive information submitted beside it, and the integrated report's text, end-of-text outputs and appendices, with who prepares and integrates each
• Who a clinical study report is written for — the purposes a report serves, the readers of the submitted report and the readers after approval with what they need from it, and where the report and its findings go
• The standards a report follows — where a report's requirements come from, the ICH E3 guideline section by section and how far its headings bind, the CORE Reference manual that interprets it, the TransCelerate common template, and why E3 and E6 came up for revision
• Choosing between a full, abbreviated, synopsis or interim report — the kinds of report a study can have, the ICH and FDA guidance on the shorter formats, when a shorter report is acceptable, and the safety data and appendices a shorter report still carries
• Writing the report — scheduling, drafting from the precursor documents and the outputs, producing the patient narratives, presenting the results for the reviewer, in-text safety tables built from immutable outputs, reporting complex safety data, and reporting a disrupted study