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A Clinical Trial Report or Clinical Study Report (CSR) is an integrated report of the clinical trial of any therapeutic, prophylactic, or diagnostic agent for submission to the health authorities. It provides a clinical and statistical description, presentations, analyses, and appendices with further details. Its purpose is to present the methodology used (including changes to the protocol) and data obtained. It is also used as source material for several other documents (eg, publications).
Note: The terms ‘clinical trial’ and ‘clinical study’ are sometimes used as synonyms but ICH E6 (R3) uses the term ‘clinical trial’, defined as any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. Investigational products should be considered synonymous with drugs, medicines, medicinal products, vaccines and biological products.
The CSR presents what was planned, what changed and why, what actually happened, and what was observed. The findings are presented at different levels of detail (ie, text part; in-text tables and figures throughout the report; end-of-text tables and figures; end-of-text participant narratives*; data listings and additional summaries; selected completed Case Report Forms; and Case Report Tabulations [US Archival Listings]). Depending on the complexity of the clinical trial, the CSR (with appendices) may vary enormously in size.
(*) Participant narratives are provided for deaths, other serious adverse events, and other significant adverse events of interest. A narrative provides demographic information and important baseline characteristics, relevant medical history and previous/concomitant medications, the disease being treated, trial treatment exposure, a detailed version of the medical event that has occurred, what action was being taken after the event, a description if the event is in any way related to the trial treatment or not, and additional relevant information from the database (eg, laboratory test results/vital signs if deemed relevant) and other sources.
In general, a full CSR will be written for each clinical trial, but other report types may be created in some instances, including an abbreviated (abridged) CSR (ACSR), a synoptic CSR, or an addendum (supplemental) CSR. For a single clinical trial, there may be multiple CSRs, including separate CSRs for different reporting periods (eg, interim CSR, primary CSR, or final CSR), or for different trial parts (eg, subtrial report). Hence, there may be different report types per clinical trial.
There are no updates to a CSR, but there can be the need for an addendum CSR to provide additional information to a full CSR.
The CSR is a multidisciplinary document involving a wide range of functions that provide input for the CSR. Their input will be necessary to produce a high-quality document. The earlier sections (methodology) are derived from several other documents (eg, protocol and statistical analysis plan), while the later sections (results) are written based on the statistical output (tables, figures, and listings).
Emtex Life Science medical writers can help you with the document development process (eg, writing, circulating for review, and implementing comments) to ensure a well-structured document that is fit for purpose and meets the regulatory reviewer’s needs.
FAQ: Clinical Trial / Study Report
What is a Clinical Trial/Study Report (CSR)?
A CSR is an integrated report of a clinical trial submitted to health authorities, describing methodology, analyses, results, and supporting appendices.
What information does a CSR include?
A CSR describes trial objectives, methods, deviations, results, tables, figures, narratives, listings, and additional summaries, with level of detail depending on trial complexity. The CSR presents what was planned, what changed and why, what actually happened, and what was observed.
When is a CSR needed?
A CSR is required for each clinical trial included in regulatory submissions and may be supplemented with addendum CSRs when additional information becomes available.
How can Emtex Life Science support the preparation of a CSR?
Emtex Life Science can manage the writing process, coordinate team input, conduct reviews, implement comments, and ensure the CSR meets regulatory reviewer needs and is aligned with other documents (eg, protocol, statistical analysis plan).
Why is professional medical writing support valuable for a CSR?
Professional medical writing support ensures accuracy, structure, data consistency, and regulatory compliance, especially for complex, data‑heavy CSRs.