If you’re new to clinical research, or even if you’re not, sooner or later you’ll be tasked with authoring a clinical study report.
These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.
“A clinical study report (or CSR for short),” explains Eli Lilly in a blog post, “Describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective.”
The first questions a novice report writer may have, therefore, are “What do I include in the report,” “What’s the report structure,” “How do I write the report”?
The International Conference On Harmonisation answers those questions in a 49 page guideline that spells out the details and includes sample forms.
Even with the guidelines, preparing a study report is complicated work, requiring the collection of data, analysis and making sure it is both accurate and complete.
Fortunately, the Association of Clinical Research Professionals recently published a much less intimidating primer answering those questions and many more. “Clinical Study Reports 101: Tips and Tricks for the Novice” provides an overview of the CSR, giving us a framework for writing and organizing a report.
The author, Sheryl Stewart, goes into just enough background to give a first time author or contributor an understanding of what needs to be in these reports and why. That goes a long way to helping us know what a report must include. She helpfully points to templates, and reassures us that “there are no requirements to follow the template precisely. Not every section is appropriate for every study.”
Her top level discussion tells us the first step is to review the templates she recommends to help you organize the report. Outlining it will tell you what documents and data you’ll need.
The next step is to identify all the stakeholders. These will certainly include the clinical study management team, those tasked with responsibility for the data and others. In a “Tips and Tricks” section Stewart suggests, “Drafting a project charter or scope document to ensure commitment from all required teammates on scope, deliverables, and timelines.”
Each of the stakeholders should be given a time table for their deliverables. “Time management is paramount for clinical trial submissions to regulatory authorities,” Stewart says.
In her section on the writing of the CSR, Stewart briefly discusses each of the six sections, offering insights into the process. Write the executive summary last, she suggests, because it will be easier then.
She also has a few tips about the review process. Have the reviewers initially focus on content. Formatting and grammar errors are much less important at this stage. She also says that once the review team has signed off on a section, discourage backtracking unless something major changes.
How long should you expect the process to take? Experienced writers surveyed at medical writing conferences came up with an average of 17 days from delivery of the final tables, listings, and figures to first draft. And 26 days from first draft to the final draft sent out for review.
Photo by Scott Graham on Unsplash