How to Write a Clinical Study Report

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

#WeAreGreenKey: Spotlight on Anthony Agosto
Accounting + Finance General Interest Green Key News Human Resources Leadership + Management Worklife

#WeAreGreenKey: Spotlight on Anthony Agosto

Shop for Jobs this Holiday Weekend
General Interest Green Key News Human Resources Worklife

Shop for Jobs this Holiday Weekend

Thankful for Our Community this Thanksgiving
General Interest Green Key News Leadership + Management Worklife

Thankful for Our Community this Thanksgiving

Green Key Unlocked: Behavioral Interviews in IT
General Interest Green Key News Information Technology Worklife

Green Key Unlocked: Behavioral Interviews in IT

#WeAreGreenKey: Spotlight on Stu Leifer
Accounting + Finance General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Stu Leifer

#WeAreGreenKey: Spotlight on Sam Jaberi
General Interest Green Key News Information Technology Worklife

#WeAreGreenKey: Spotlight on Sam Jaberi

Preparing for Different Types of Interviews
General Interest Green Key News Human Resources Worklife

Preparing for Different Types of Interviews

Benefits of Working Hybrid
General Interest Green Key News Worklife

Benefits of Working Hybrid

Green Key Unlocked: How to Succeed in Desktop Support
General Interest Green Key News Information Technology Worklife

Green Key Unlocked: How to Succeed in Desktop Support

#WeAreGreenKey: Spotlight on Andrew List
Financial Services General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Andrew List

How to Improve Sleep Hygiene (For a Better Work-Life Balance)
General Interest Green Key News Healthcare Worklife

How to Improve Sleep Hygiene (For a Better Work-Life Balance)

#WeAreGreenKey: Spotlight on Karlina Cordero
General Interest Green Key News Human Resources Worklife

#WeAreGreenKey: Spotlight on Karlina Cordero

How to Ask for a Raise
General Interest Green Key News Worklife

How to Ask for a Raise

#WeAreGreenKey: Spotlight on Brittany Kinsella
General Interest Green Key News Leadership + Management Worklife

#WeAreGreenKey: Spotlight on Brittany Kinsella

Green Key Unlocked: Why Green Key?
Accounting + Finance Architecture + Engineering Financial Services General Interest Green Key News Healthcare Human Resources Information Technology Leadership + Management Legal Support Marketing Technology Pharma Professional Support Worklife

Green Key Unlocked: Why Green Key?

#WeAreGreenKey: Spotlight on Samantha Leveille
Architecture + Engineering General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Samantha Leveille

How to Answer Salary Expectations
General Interest Green Key News Worklife

How to Answer Salary Expectations

#WeAreGreenKey: Spotlight on Sean Coyne
Architecture + Engineering General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Sean Coyne

Questions to Ask During a Job Interview
General Interest Green Key News Human Resources Worklife

Questions to Ask During a Job Interview

#WeAreGreenKey: Spotlight on Angela Singh
General Interest Green Key News Human Resources Worklife

#WeAreGreenKey: Spotlight on Angela Singh

Latest Blog Posts
View All Posts
#WeAreGreenKey: Spotlight on Anthony Agosto

#WeAreGreenKey: Spotlight on Anthony Agosto

Anthony has been with Green Key for over eight years and has played an integral role in the success of...
Read More
Shop for Jobs this Holiday Weekend

Shop for Jobs this Holiday Weekend

This coming weekend may call for hearty food, crazy sales, and some quality down time to unwind. But while you're...
Read More
Thankful for Our Community this Thanksgiving

Thankful for Our Community this Thanksgiving

As Thanksgiving approaches, we'd like to take the time to thank our amazing Green Key community! This includes all of...
Read More