January 12, 2024

What are essential medical writing documents in the field of clinical and regulatory writing?

Medical Writing University

Essential documents are key documents that all clinical and regulatory medical writers new or transitioning into the field should be able to author with little or minimal guidance. These types of documents include clinical study protocols, clinical study reports (CSRs), and subject narratives.

As an early career medical writer, you can anticipate that 90% of your clinical authoring workload will cover at least all 3 document types. Therefore, as a medical writer, it is critical that you have a strong foundation in initiating, authoring, and finalizing each of these essential documents. As a more experienced writer, you will be expected to be able to perform document peer reviews and/or lead protocol, CSR, and narrative projects.

1. Clinical Study Protocols

A clinical study protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study. Clinical study protocols can cover Phase 1 to Phase 4 studies. Most medical writers are either early-stage (Phase 1/1b and Phase 1b/2) and/or late-stage (Phase 2-3) writers.  

2. Clinical Study Reports

A full clinical study report is a document that describes the clinical and statistical description, presentations, and analyses of a completed study. The clinical study report should include an explanation of the critical design features, the plan, methods, and conduct of the study, summarized efficacy and safety, individual patient data, and details of analytical methods. Most new clinical and regulatory medical writers are quickly assigned to support CSR authoring under the direct supervision of a more senior writer.

3. Subject Narratives 

A narrative is a brief document summarizing specific events experienced by patients or subjects, during the course of a clinical trial. Narrative writing involves multiple activities and often times requires multiple medical writers depending on the number of narratives that are required. Frequently, new clinical and regulatory medical writers are assigned to support narrative authoring under the direct supervision of a more senior writer.

Here at Medical Writing University, we understand that there are a number of unique challenges that a medical writer might encounter while writing protocols, CSRs, and subject narratives. Therefore, we have tailored medical writing courses to carefully describe the authoring process while offering a unique opportunity for hands-on writing to help address challenges and provide feedback and ideas to help you successfully manage new medical writing projects.

Register for our next medical writing course information session and learn more about the field of clinical and regulatory medical writing as well as our medical writing courses.

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