Staff Reporter
Electronic case report form (ECRF) is utilized in the health industry to collect data for clinical trials. With the sensitivity of clinical trials, you need a system that you can fully rely on. When it comes to ECRF, you can improve its efficiency by working on its design. This article will guide you in managing your ECRF design to enhance your clinical trials. Read on to know more.
Ensure Clarity
Clarity is key when it comes to filling out forms. This will eliminate ambiguity and ensure your patients fill in their information in your desired format for you to get the most from this.
To get the desired results, you can control the kind of responses you get from your patients. Consider incorporating pre-coded answers, such as yes/no or mild/moderate/severe when describing pain levels, among others. Adopting pre-coded answers will eliminate bias and errors in the filling out process.
You should also ensure you properly issue instructions to the respondents. Let them know how to go about the form. The instructions shouldn’t only be in the introduction; walk with them throughout the journey. Additionally, refrain from sticking to one form of questioning and try mixing things up. For example, provide yes/no questions, open-text questions, among others. You can use open-text questions for data needing an explanation for better understanding during analysis. Consider using an operational data model to help you with this.
Allow Simplicity
Simplicity is everything when it comes to filling out an electronic form. You want your patients not to be overwhelmed by the whole process and to fill in the correct data.
To achieve simplicity, consider using simple language that your patients understand. With this, there’ll be no distortion of information in interpretation, ensuring you get accurate and relevant data.
Arrange the form in an organized manner without having too much information on a given page. Here, you don’t have to worry about printing costs. After all, you’re using an electronic form, so utilize medium or large fonts on it. However, don’t go overboard with the font and end up with several pages for your patients to fill. They might get overwhelmed by just seeing the number of pages they must go through and abandon the process.
By adopting simplicity in your ECRF design, your form will be user-friendly, which is an ingredient for getting accurate data for your clinical trial.
Incorporate Required Fields
During a clinical trial, you want to collect as much vital information as possible. As your patients fill out the form, there’s a high possibility of some deciding not to answer some sections. This is often because of errors in the filling-up process.
However, invasive or not, you need these data for your clinical trial to succeed. Therefore, to compel your patients to answer the questions, incorporate required fields on your electronic form. Do this for the critical data you need while allowing for a choice of answers on data that are less important in your trial.
With the required fields in place, you’ll collect the most critical data for your trial, thereby increasing its success rate.
Collect Quantifiable Data
It’s essential to ensure you collect quantifiable data. Quantitative data are easier to measure compared to qualitative data. Qualitative data increase room for many assumptions, which isn’t ideal in a clinical trial.
Quantitative data allow you to perform various calculations to get different results and draw various conclusions, all of which contribute to your trial’s success.
To collect quantitative data, adopt measurable answers through pre-coding, as previously stated, especially on the most vital data of the form. Quantitative answers can be mild/moderate/severe, or ratings from 1 to 10.
Incorporate Edit Checks
Without the use of edit checks, you’ll end up with large amounts of inaccurate data, which won’t help with your clinical trial. This is mainly due to errors in the form-filling process.
Once you incorporate edit checks in your ECRF design, you’ll increase the quality of data you collect. This is because edit checks will offer real-time monitoring of the filling-in process. This system will notify patients if they incorrectly input data, such as an email or answer format. Thus, the patient will make prompt corrections, ensuring they’ll submit a form with all correct data.
Edit checks reduce the data cleaning process, lifting off the burden from your data analysis team. With this, they’ll focus more on data analysis and interpretation, which speeds up your clinical trial.
Conclusion
The use of ECRFs directly impacts the efficiency of your clinical trial. Therefore, your ECRF must be top-notch to guarantee a successful clinical trial. A way to ensure this is to work on your ECRF design. To do this, consider implementing the tips given in this article.
