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

What It Means to Be a Leader During a Time of Crisis
General Interest Leadership + Management Worklife

What It Means to Be a Leader During a Time of Crisis

Mid-Life Crisis? Consider a Mid-Life Career Switch
Accounting + Finance General Interest Information Technology Leadership + Management Worklife

Mid-Life Crisis? Consider a Mid-Life Career Switch

Lawyers Look to Move Firms to Keep Remote Work
Legal Support

Lawyers Look to Move Firms to Keep Remote Work

Is the Hybrid Workplace Sustainable?
Worklife

Is the Hybrid Workplace Sustainable?

Bank of America, Competitors to Raise Pay
Financial Services

Bank of America, Competitors to Raise Pay

Class of 2021 to Enter Job Market
Financial Services Healthcare Information Technology Marketing Technology Professional Support

Class of 2021 to Enter Job Market

Pharmacies Are Entering the Mental Health Market
Healthcare Pharma

Pharmacies Are Entering the Mental Health Market

Pandemic Challenges Create New Opportunities for Virtual Career Development
Worklife

Pandemic Challenges Create New Opportunities for Virtual Career Development

America’s New Tech Hubs
Information Technology

America’s New Tech Hubs

How to Recognize if a Manager Is Right for You
Worklife

How to Recognize if a Manager Is Right for You

Green Key Resources is Hiring!
Accounting + Finance Architecture + Engineering Creative Financial Services Healthcare Human Resources Information Technology Legal Support Marketing Technology Pharma Professional Support

Green Key Resources is Hiring!

How to Think Like a Lawyer
Legal Support

How to Think Like a Lawyer

3 Questions to Unlock Your Authentic Career
Creative Worklife

3 Questions to Unlock Your Authentic Career

Businesses Rethink “Necessary Travel”
Worklife

Businesses Rethink “Necessary Travel”

YOLO Is Sparking Riskier Career Moves
Worklife

YOLO Is Sparking Riskier Career Moves

21 Ways to Celebrate Earth Day Today & Beyond
Architecture + Engineering Worklife

21 Ways to Celebrate Earth Day Today & Beyond

Want to Feel More Connected? Try Some LOLs
Leadership + Management

Want to Feel More Connected? Try Some LOLs

In a Time of Crisis, What Makes a Good Leader?
Leadership + Management

In a Time of Crisis, What Makes a Good Leader?

The Pandemic Is Altering Data Privacy Expectations
Information Technology

The Pandemic Is Altering Data Privacy Expectations

Job Openings Hit a Two-Year High
Human Resources

Job Openings Hit a Two-Year High

Latest Blog Posts
View All Posts
What It Means to Be a Leader During a Time of Crisis

What It Means to Be a Leader During a Time of Crisis

During the early months of the pandemic, team leaders, managers, and company executives had to use cognitive reframing to build...
Read More
Mid-Life Crisis? Consider a Mid-Life Career Switch

Mid-Life Crisis? Consider a Mid-Life Career Switch

Far too often, ages and life stages are regarded as barriers to starting a new career. But the mid-life career...
Read More
Lawyers Look to Move Firms to Keep Remote Work

Lawyers Look to Move Firms to Keep Remote Work

As law firms across the country consider brining an end to remote work, some lawyers and other legal professionals are...
Read More