What a clinical study report is made of
A clinical study report is submitted as a core report with supportive information beside it. Once integrated, it has two main parts, a text part and appendices. The medical writer and other functions prepare its components, and a publishing group usually integrates them.
The core report
The core report contains the components of a clinical study report that the ICH E3 guideline sets out. For clinical pharmacology studies, the efficacy section of the core report is replaced by pharmacokinetic and pharmacodynamic data. The core report's appendices should include the list of investigators, exclusions from analysis, secondary analyses, adverse event listings, and any study-related publications.
Supportive information
A clinical study report submission requires supportive information in addition to the core report. The supportive information comprises study documentation, efficacy listings, safety listings and statistical details.
The study documentation should include the protocol and amendments, case report forms, informed consent documentation, the list of ethics committees, the randomization code list, and a glossary of terms. The efficacy listings should include demographic data, previous and concomitant conditions, previous and concomitant treatments, and primary and secondary efficacy parameters. The safety listings should include adverse event and laboratory data. The statistical details should include methods of analysis, results and conclusions, and center displays of demographics, efficacy and safety.
The integrated report
The integrated clinical study report has two main parts, a text part and an appendices part.
Under the ICH E3 headings, the text part comprises Sections 1 to 13 and Section 15, and the medical writer writes it. Section 14 contains the end-of-text tables, figures and graphs, essentially the summary statistical output, and also the clinical narratives when including them in the body of the report would disrupt its flow. The medical writer or the drug safety group usually writes the narratives.
The Section 16 appendices comprise study information, data listings and the relevant case report forms. The appendices may be collated and assembled into electronic folders by the medical writer or by a document support group.
A dedicated publishing group usually integrates the text, the Section 14 outputs and narratives, and the Section 16 appendices electronically. The medical writer has a driving role in preparing all of these components and must engage with many other functions to produce a high-quality document, delivered on time.