Sunday, January 16, 2011

Writing a clinical study report?

So, this is my first post for a brand new year! Although it's already two weeks into 2011, but better late than never! ;)

Anyway, work has been busy with lots of writing assignments in the office, one after another. And amidst my already tight assignment deadlines in the office in the last couple of months of 2010, I had also faced tight deadlines after work - a freelance clinical study report (CSR) project for a drug company.

I had no experience in writing CSR in my previous job as a medical writer, so that was my first time. Thankfully, it was a small clinical study and results were pretty straightforward to interpret, and a standard template was provided for my reference.

However, for a medical writer who has not written a clinical study report before, it still appears as a daunting task, and I started to look around for information to assist me in this project. If you are a freelance medical writer interested in getting clinical study report projects or about to embark on one, here are three resources that may be of great help to you:

1. Efficacy guidelines from ICH - Here you'll find a list of guidelines to writing various regulatory documents pertaining to clinical studies, e.g. CSRs, clinical trials, good clinical practice, dose-response studies, etc. The guidelines are available in downloadable PDF format.

2. 48 Things Medical Writers Need for Clinical Study Reports (CSRs) - If you're wondering what information you need to acquire from your client before you can start writing a CSR, visit this blog belonging to an experienced medical writer, Susan Caldwell. In that particular post, you are given a list of things required to help you draft a clinical study report. Without having all the necessary information at hand before you begin writing, the writing process may be delayed as you would have to keep going back to your client to request for the missing information.

- As I was searching for a guidebook to help me prepare the CSR, I came across this book from Amazon. The book is useful for those who writes regulatory documents for the biopharmaceutical industry. It covers not only CSRs, but also on writing clinical study protocols, investigator's brochure, product dossiers, patient informed consent form, etc. The book also includes samples of clinical protocol synopsis, clinical protocol signature page, informed consent form and more. Basically, it covers all documents needed right from the preparation of a clinical study to submitting its report.

Get this book from Amazon now and save 10%!

I didn't buy the book because, firstly, it is not available in my local bookstores, and secondly, I'm not sure if there will be a second CSR project for me. But I definitely will keep this book in mind for future reference.


clinnovator January 30, 2011 at 3:00 AM  

Medical writing is only for those who has passion and love to learn new things on daily basis. Your scientific knowledge and analytical skills improve each day with every assignment.One must develop habit of reading medical books and Journals. I prefer it is always good to read articles from Medical Research Journals.

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Pat May 16, 2011 at 6:44 AM  

I found this post to be very useful and am especially curious as to whether you have any advice for someone in my position: I have produced several medical journal manuscripts and have been producing technical content for drug and device companies for more than 10 years. Although I work with regulatory documents daily, every regulatory writing opportunity I've encountered will not consider anyone who lacks experience producing regulatory documents (but you can't get that experience if you aren't hired at some point...) Do you have any advice for someone with an extensive "high science" writing background who is very familiar with regulatory documentation and wants to transition from *working with* these documents to *producing* them?

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