A clinical study report (CSR) is a comprehensive regulatory report describing the data and outcomes observed in a clinical study.
As a medical writer, you may be familiar with other types of regulatory reporting, such as annual progress reports or safety reporting to a regulatory body, institutional review board (IRB), or ethics committee. However, a CSR is larger in scope than these other types of reporting.
Often medical writers are called upon to write a CSR. However, it should be noted that investigator‑initiated studies also require CSRs, and the production of a CSR may fall upon study team members whose primary role is study conduct, and not medical writing. Regardless of your role in a clinical investigation, before you start crafting your first CSR, it is important to understand why a CSR is required, when a CSR might be needed, the expected scope and components of the document, and the expected team members and stakeholders in the process.
Investigators and study sponsors already assume an ethical responsibility to clinical study data transparency whenever a clinical investigation is initiated. However, the practice of formalizing this transparency has been written into Good Clinical Practice (GCP), and indeed, the International Council for Harmonisation (ICH) includes CSRs as part of GCP in the ICH GCP E6 (R2) guideline. To further aid in the process, a guideline has also been created: the ICH E3 Guideline for Industry; Structure and Content of Clinical Study Reports.
When Is a CSR Written?
A CSR is required to be produced at the end of an investigation to report the study outcomes with the regulatory authority. However, it also may be produced at other times within the course of a study
- at the time of submission for product commercialization,
- at a prespecified point during the investigation or after commercialization for reimbursement purposes, or
- at any time to provide current study outcomes desired for inclusion in regulatory documents, such as clinical evaluation reports, or for scientific publications.
What Are the Main Components of a CSR?
A CSR is not unlike a journal article reporting study outcomes. It will begin with an introduction to the therapeutic space, orienting the reader to a problem or disease state, and the need for the therapy or method under study. It will provide a description of the study processes or protocol (think “methods” section).
It will then go into great detail presenting the clinical study outcomes in text and tables or figures. If the clinical study has prespecified endpoints or hypotheses, the CSR will report the status of the data against these endpoints or hypotheses. Statistical analysis, which would be prespecified in a statistical analysis plan, will be required to accurately and appropriately interpret the study results and place them into context.
A CSR may include a discussion section about how these study outcomes can impact or inform the state of the art of the therapeutic space. Any key messaging, supported by the outcomes observed, will be described here. In many cases, references to published literature will be helpful.
Published evidence may be included to support any assertions or conclusions, but it will be an especially important task for those medical writers who are unfamiliar with the therapy under study. In order to provide an informed discussion of the study’s impact on patients or a therapeutic space, the writer needs a good understanding of what the regulatory authority is seeking, as already seen either in other study reporting or in the published clinical evidence.
Lastly, a CSR offers conclusions based on the study results, discussion, and insights from the literature review.
Various online templates and guidelines are available for reference:
- ICH E3 Guideline for Industry; Structure and Content of Clinical Study Reports;
- TransCelerate CSR template;
- Study sponsor‑created CSR templates
- CORE Reference
Producing a document that contains the components that the regulatory authority is expecting to see should help minimize questions and streamline their review. The medical writer should inquire whether a prespecified sponsor template should be used, and if not, then the ICH E3 will likely meet the regulatory authority’s requirements, or at least will be an informed place to start.
Who Will You Need to Help Create a CSR?
After reading the above, you probably have a sense for the team you will need to assemble in order to complete this large‑scale project. Clinical study management or site staff, data management personnel, and statisticians will all be important team members to include in discussions about the components of the CSR.
Access to a medical librarian or at least research access to scientific journals will be helpful. All these team members’ contributions will be necessary to produce the important document that will present the outcomes of your study and inform readers about the impact of the research.
Whether you’re a novice to the field or an experienced medical writer, undertaking a new deliverable that carries an impact as large as a CSR can be daunting.
Having a strong understanding of the scope and the regulatory expectations for the content can help ease stress and worry.