Case Report Forms (CRFs) are crucial documents in clinical trials. Clinical trials are done in the medical field to improve healthcare through developing new drugs, finding cures for illnesses, and manufacturing new medical devices. These three are the cornerstones of general public health.
During these trials, you require participants who’ll provide the data you need for the process. These participants are known as patients in clinical trials. The data you get from these participants is what you’ll use to determine whether your trial hypothesis is correct or not. Suppose you’re looking for a cancer cure.
You’ll give these patients the medication you believe is the cure. Based on their bodies’ reactions and the progress of the disease in their bodies, you’ll know whether the drug is the cure or not.
Due to the sensitivity of clinical trials, CRFs need to be efficient. These forms are where the patients will fill in the data you require from them. Make a point of using the internet to find the best page that gives more information about CRFs.
As a clinical researcher, how will you ensure you design an efficient CRF for your clinical trial? This article will give you design tips to adopt; worry not.
Here are the tips:
Work On Organization
Organization in this context refers to how you arrange your CRF’s content. The arrangement directly impacts your patients’ emotions, affecting the quality of data you get from them. What organization technique should you adopt?
One, consider adopting the right font for the questions. The font refers to the size of your letters and characters. They shouldn’t be too large or small. Fonts that are too big might appear as if you’re shouting at the patients, while fonts that are too small might overwhelm the patients just by looking at them, creating stress.
Both situations evoke negative emotions, which aren’t ideal if you’re looking to collect quality and accurate data from your patients. Therefore, it’d help to find a balance between large and small fonts.
Also, it’s best to minimize the pages of your CRFs. Many pages might make your patients tired even before filling out the form. Some might abandon the process midway, which you don’t want. You can achieve fewer pages by collecting only the data you require for the trial. This minimizes the number of questions you have to ask, reducing the overall pages.
Last but not least, ensuring a continuous thought process for your patients is important. This ensures consistency and prevents going back and forth from one question to another, a process that might affect the data you collect.
You can achieve this thought process by grouping similar questions in one section. If it’s personal information, let it be on its own; the same applies to side effects and other aspects of the trial.
Take Control Of Your Answers
In a clinical trial, there’s data which your trial depends on. Otherwise, you can’t proceed with the trial. Therefore, to get the data you require for the trial, consider controlling the type of answers you receive from the patients. You can do this by formulating your questions accordingly.
One sure way of controlling your answers is adopting pre-determined answers, such as yes or no. Such answers will steer your trial in the right direction, and you won’t need to interpret the answers. You’ll use the answers as they are, avoiding assumptions that interfere with the quality of your results.
It’d also help to let the pre-determined answers go hand in hand with explanations. The explanations are what you’ll use to give the reasons for your conclusion. For conclusive results, refrain from using either independently.
Uncertainty in a clinical trial is unwanted; it might bring all your efforts to waste. When your patients are uncertain about the questions, they might give you the wrong data, making you draw wrong conclusions for the trial. However, you can minimize and eliminate these uncertainties by working on your CRF’s design.
Like other designs, such as mobile design, user experience is key in ensuring effectiveness. With CRF, you can enhance your patients’ experience by using simple language in the form. Simple language without using jargon eliminates confusion and misinterpretation of the questions. You and the patients will be on the same page regarding a given question, ensuring you get the answer you require.
In addition, it’s advisable to refrain from using words with double meanings. A word can have a different meaning across various languages, leading to wrong interpretations.
As part of eliminating uncertainty, adopt a universal language that all your patients understand. However, if your clinical trial limits your patients to a given ethnicity, you can use their native language for better understanding. This is ideal if illiteracy is a common attribute among the patients.
From the discussion above, you’ve seen that arriving at an effective CRF design isn’t daunting. The read has divulged tips you can adopt to ensure you achieve the same effective CRF design for your trial. Consider implementing them, and you won’t have to repeat the data collection process due to inadequate or unreliable data.