Medical communicators new to writing clinical study reports may find the process overwhelming. The report is more detailed and structured than many other regulatory documents, and new report writers don’t necessarily know what regulators or stakeholders expect.
What's the best approach to writing a clinical study report (CSR)? Medical writers typically develop these documents in collaboration with a team, following a general structure that includes a synopsis, an introduction, processes, outcomes, discussion, and conclusions.
This blog covers the basics for medical communicators tasked with preparing clinical study reports, whether as part of regulatory submissions, investigator-initiated studies, or publication support. By the end of this article, you’ll understand what a clinical study report is, when it's needed, the essential components of the report, and the team members involved, giving you a roadmap to approach clinical study report writing with confidence.
A clinical study report is a detailed document that presents the data and outcomes from a clinical study, prepared primarily by pharmaceutical companies for submission to regulatory authorities. As a medical writer, you may be familiar with other types of regulatory reporting, such as annual progress reports or safety submissions to a regulatory body, institutional review board (IRB), or ethics committee. Unlike these reports, however, a clinical study report provides a more comprehensive account of the study.
At the conclusion of a clinical investigation, a clinical study report must be prepared to document and submit the study outcomes to the regulatory authority. However, it also may be produced at other times during the course of a study, such as:
A clinical study report is not unlike a journal article reporting study outcomes, but it is more detailed in scope and written with regulatory requirements in mind. A typical clinical study report includes these components:
The contents of a clinical study report may vary. Commonly used templates and guidelines include:
Producing a clinical study report that contains the components that the regulatory authority is expecting to see should help minimize questions and streamline their review. Medical writers should first determine whether the sponsor has a prespecified template to be used. If not, the ICH E3 guideline will generally meet regulatory requirements and serve as a reliable starting point.
Because a clinical study report is a large-scale project, assembling the right team is essential. Key contributors typically include clinical study management or site staff, including clinical research physicians or drug safety physicians, data management personnel, and statisticians, all of whom provide clinical input for the report. Access to a medical librarian—or at minimum, research access to scientific journals—can also be invaluable. Each team members’ contributions are necessary to develop a document that not only presents study outcomes but also explains their impact within the broader research context.
Medical writers are often tasked with drafting the clinical study report. However, for investigator‑initiated studies, the responsibility may fall to study team members whose primary focus is conducting research, rather than medical writing.
Whether you’re a novice to the field or an experienced medical writer, taking on a deliverable as significant as a clinical study report can be daunting. A clear understanding of the report's scope and the regulatory expectations for its content can help medical communicators develop an effective clinical study report.
This blog was originally written by Sheryl Stewart, MCR, CCRP, in 2021. It has been rewritten by AMWA for republication. AMWA acknowledges the contributions of Kecia Brown, MPH for peer review in the development of this AMWA resource.