Regulatory Writing: Overview

Regulatory writers create an extensive range of clinical documents during the life process of a probable treatment, beginning with the description and report of the data from clinical tests, by making regulatory submission documents, and, if occupational therapy is accepted by the administrative authority, writing post-approval reports on the suitability of the treatment in patients. Some of the examples of clinical documents are Investigator Brochures (IBs), Common Technical Document (CTD), Clinical Study Protocols, Clinical Study Reports (CSRs), and more. Usually, the audience for these documents is regularity authorities and ethics committees.

Importance of Regulatory Writing:

The significance of developing prime-quality regulatory documents is usually undervalued; a Clinical Study Report (CSR) is the conclusion of several years of hard work by research teams and has to sum up the treatment and results of clinical research in a clear manner.

A properly-composed CSR help in the consequent production of quality documents submission. On the other hand, badly composed regulatory documents may result in latency of regulatory approval, taking time and money of the sponsor.

Tips for Regulatory Writing: Following are some of the tips for effective regulatory writing:

Understand The Goal of Your Document:

First of all, you need to understand the goal of your report or document in a crystal clear manner and what you can do to accomplish that goal. There are various stages in drug improvement, and it is very much important to recognize the role of your medical report or document in the overall picture plus what you can do to make it effective.

Furthermore, you need to understand what does your reviewer want to know from your report or document to evaluate its success.

Recognize The Regulatory Guidance:

Secondly, you need to understand the regulatory guidance associated with the type of your document. Obviously, you cannot ignore the directions of the regulatory. If an administrative authority has assigned guidance associated with a specific document type, it benefits you to follow their guidance. For instance, some consider that the ICH E3 guideline for CSRs is a template, although it is a guideline.

Make Sure Your Document Reflect a Clear, Short, and Sound Message:

Try to provide a clear, short, and sound message. Once you clearly understand the purpose of your report or document and the regulatory requirements precise to that document, ensure that the fundamental message and summary are transparent to understand for the reviewer.

Be consistent:

Make the document easy for the reviewer by giving consistency. For the effective regulatory documents, try to provide consistency in messaging, language, and format of your document. To improve consistency in your documents, you can follow a style guide or use templates.

Provide Enough Contexts:

Many reviewers do not read a report or document from top to bottom. As a report or document will likely be evaluated via numerous states of controls, it means that the reviewer may start his evaluation at any of the points he thinks appropriate.

Keep this in mind and try to repeat the most needed information at multiple places to provide sufficient context throughout a document. However, excessive repetition is not ideal that’s why to make repetitions only when needed.

You Document Should Be Easy To Navigate:

One of the most important things that you need to keep in your mind is to make the document or report easy to navigate. Nowadays, most of the reviewers review documents electronically. For example, you can use cross-references to find supportive information. Also, you can go with the use of sub-headings in order to make the document easy to navigate for the reviewer.

Write By Keeping The Conclusion In Mind:

Before you begin to write, keep all the point in your mind that you are going to discuss in the document or report. Also, you should know how you are going to end that particular report; try to write in the same sense from the beginning.
ADI-Intellect is a well-known medical writing agency in the USA. Here you can contact us to get effective solutions on regulatory medical writing services all around the world.


Get in Touch