Learning The Basics Of A CRF Design Process

A case report form (CRF) is a document medical researchers use to collect data for clinical trials. Patients involved in the trial will fill out these forms accordingly and furnish the data to the researchers for analysis.

Clinical trials serve an important role in the health industry. Therefore, quality is of the essence in each phase. With CRFs being part of the process, they also bring about efficiency, particularly when well-designed. How? Read on to learn the basics of an efficient CRF design.

Use Simple Language

Simplicity is key when formulating your case report form. Achieve this by using simple language. The language should be one your patients understand extensively, such as a universal language or a common native one. Besides the language, simplicity also means using simple words and not jargon. 

The aim of utilizing simple language is to leave no room for misinterpretation. You don’t want each of your patients to interpret your questions differently. You’re likely to end up with inaccurate data; you don’t want that. If you can’t find alternative words to jargon, ensure you explain its meaning. This will aid the patient before answering. 

Besides eliminating the possibility of misinterpretation, simple language will make all your patients feel they belong. With the use of jargon, some might feel out of place or undermined. Such emotions are likely to negatively interfere with how these patients fill out your CRF, which you don’t want.

Adopt Pre-Coded Answers

Your clinical trial largely depends on the type of data you get from your patients. Some types of data are easy to analyze, while others are challenging. In this case, quantitative data is easier to work with than qualitative data. Therefore, the CRF design process must involve collecting more quantitative data than qualitative. Adopting pre-coded answers will help you achieve this.

Pre-coded answers can be ratings from 1-5, yes or no, and others. Such answers allow you to work with numbers, from which you can perform several analyses and draw different conclusions for your clinical trial. In most cases, qualitative data tends to require your patients’ opinions about the given subject matter. It’d be difficult to draw valid conclusions; you’ll make several assumptions.

Use The Right Font

Font, in this context, refers to the sizing and styling of your letters on the CRF. It’s essential to get this right to stir the right emotions in your patients. It’d help not to use very large fonts on your form. These will appear to be shouting at the patients, which isn’t the right first impression before they start filling in the form. They’re also likely to feel overwhelmed before they start as the form will seem long, even if it’s not.

On the other hand, it’s also not best to use very small fonts. Your patients might find it challenging to read.  

Therefore, you should find a balance between large and small fonts

Organize Your Form

There are various aspects of organization which you need to check. One, consider grouping similar questions together on your CRF. It’ll ensure a continuous thought process, improving the quality of answers you get. If the questions pertain to the side effects of a given drug the patients are taking, general knowledge, and opinions, group each under its category. This way, when patients gets to a given section, they’ll put their sole focus on the drug, then move to the next. As you group the questions, it’d help to add subtitles to each to give the patients a rough idea of what the questions entail. The titles will also set the right tone.

As part of organization, reduce the number of pages on the form. You can achieve this by only collecting relevant data for your clinical trial. Many pages might overwhelm the patients, especially those who don’t have the luxury of time to answer a 10-page case report form. Some might abandon the process, while others might fill in the form blindly just to be done with it. This affects the quality of data you’ll get.

Incorporate mandatory questions

You need different types of data for your clinical trial. Some will be the cornerstone of your trial, without which your trial will be useless. In contrast, other data isn’t that essential. When filling out CRFs, some patients are likely to leave some parts blank accidentally or intentionally. This is likely to happen if some of the questions are invasive, intimidating, or unclear. 

It’s important that you incorporate mandatory questions in the CRF. These will be questions the patients have to answer. It’s best to indicate this on the form through a brief note for patients to understand why they need to provide answers.


This article has shown that the CRF design process is quite simple. However, it’s only simple if you have the right guidance like this article gives. Therefore, consider adopting the tips given herein as you design the case report form for your clinical trial. You’ll have an easy time, and you’ll collect reliable data.

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