4 Effective Practices For An Optimized CRF System In Clinical Trial Research

 

 

Clinical research is an important element of the health sector. Through research and trials, researchers will develop medications, identify new illnesses, and gather data regarding them. This information helps medical practitioners manage the health of their patients. One of the first steps during clinical research is to have a trial.

A trial allows researchers to collect data regarding their topic. They’ll get this data from the general public or those dealing with a certain illness. The people involved in data collection are commonly referred to as patients.

The patients have to fill out Case Report Forms (CRF) from which you’ll get the data you need. Researchers will then analyze this data. The case report forms need to be in a manner that allows for efficiency in the clinical trial process. How will you ensure that the CRF you design is well-optimized? This article addresses this question. Read on.

Your health organization can adopt the following practices:

1. Control Responses

During a clinical trial, you want to collect data that will assist you in concluding your research. The style you’ll adopt in your CRF will determine if you get the data you’ll need or if it’ll be a waste of your resources. One way of ensuring you get the right data is by controlling the responses on the CRF.

Consider adopting a close-ended format in your case report form design. You’ll have pre-determined answers, such as yes/no, or mild/moderate/severe. It’s much easier to draw conclusions from such data than in an open-ended format.

With an open-ended format, the patients will answer the questions as they see fit, which might not be satisfying to the aim of your research. However, mix things up and incorporate both close and open-ended formats to prevent the patients from feeling as if you’re controlling them. Some don’t like such approaches and might abandon the process altogether.

2. Add Mandatory Fields

During a clinical trial, you want to collect as much information as possible to get conclusive results that you can rely on. Some of the information you need might be intrusive, depending on the context of your research. Some patients might not be comfortable divulging such information.

In such situations, most will decide to leave the spaces blank and only answer those they’re comfortable with. This isn’t ideal and won’t help with your clinical trial research. Therefore, consider adding mandatory fields on the case report forms.

It’s best to mark mandatory only the most important aspects of your research. These are the aspects where, without the said data, you can’t continue with your research. Be sure to inform the patients of what’s expected of them under the instructions in the beginning. As you do this, please give them the leeway to choose whether to fill out the other parts or not.

3. Make The Forms User-Friendly

When designing case report forms, it’s important that your patients feel relaxed as they fill out the forms. When relaxed, they’ll provide you with accurate data you can rely on for your clinical research.

Ensure the CRF is organized in a manner that makes it user-friendly. What does this mean? It means using the right font size for the wordings. The fonts shouldn’t be too large or too small. Large fonts might make the patients feel that you’re shouting at them. On the other hand, very small fonts will make it difficult for the patients to read the questions. Both situations aren’t ideal since some patients might abandon the process halfway, leaving you with no data to help with your clinical trial research.

Also, ensure that you don’t condense too much data on one page; space out everything reasonably. As you do this, be wary not to end up with CRFs that are too long. Many pages might make the patients get tired of filling them out even before starting the process. Others might not have the time to fill all the pages.

Most of them will abandon the process, leaving you in a bad position. You must find a balance to ensure the pages aren’t too long. You can do this by collecting only the data you need for your clinical trial, which also helps you comply with data protection regulations.

4. Ensure Clarity

The clarity of CRFs directly impacts the quality of data you’ll get. You want to have as many correctly-filled forms as possible to help your research. How do you ensure this?

It’s simple. Use a language that’s easy to understand. You can decide to use a universal language, such as English, or one your patients resonate with. If your patients are native speakers, use the language they understand best to accommodate everyone. By utilizing simple language, there’ll be no misinterpretations or ambiguity. Misinterpretations will make the patients fill in the forms as they understand them, rather than how you want them to understand the questions.

Clarity also entails using simple phrases and wordings that a general audience can understand. Refrain from using jargon, especially those in the medical field. If it’s not possible to use a simpler synonym of the jargon, explain its meaning next to it for your patients to understand.

It’s also advisable to give instructions on how you want the patients to fill out the CRFs, preferably at the beginning. Alternatively, have them both at the start and in sub-sections that the patients might find challenging to understand.

Clarity ensures both you and your patients are on the same page regarding the data you need from them.

Conclusion

A case report form is an essential document in the health industry. Therefore, it needs to be in a manner that ensures efficiency whenever researchers use it. This article has discussed ways you can ensure the efficiency of these forms. Be sure to adapt them to avoid errors and bottlenecks.