In this post, we touch upon a few elements that can help you design a good Electronic Case Report Form (eCRF) when conducting clinical investigations.
Over the years we have assisted numerous organizations in designing eCRFs, which has been the foundation for our seven principles behind a good eCRF.
Through extensive experience with medical device clinical investigations, we know for a fact that studies with well-designed forms perform better, compared to those who attempt to copy their existing paper CRF design directly into an electronic CRF process. Replacing existing paper-based CRF processes must be done with the additional capabilities of the eCRF in mind. If not, many of the challenges in paper-based CRFs will simply be transferred to the eCRF. Additionally, utilizing best practice for eCRF design directly have a positive impact on compliance rates, data quality and communication between study participants. This will often lead to decreased time spent on data management, which results in reduced costs and eventually shorter time to market.
Paper has some notable qualities which support its claim for the golden standard of data collection, but it does have several drawbacks. Drawbacks that can make the transition to an electronic case report form more desirable.
The move from a paper-based case report form (CRF) to an electronic case report form (eCRF) can be a challenge. This is due to the inherent differences between paper and the computer as CRF mediums.
As mentioned, the worst thing we can do is to simply copy the existing paper-based CRF directly into an eCRF format. Meaning, copying the design directly into the eCRF, making the two look identical and calling it a day.
Traditional CRFs are not always printed. People have been using Word, Excel, or other common digital solutions, as data collection methods. Such solutions have their drawbacks as well. You can learn why you should avoid using such solutions from our post on "Are we breaking the law by using Excel in Medical R&D"
We identify 7 principles behind a good eCRF design process and want to exemplify how you can apply them to your own case report form design.
Here are the first three principles:
1. Eliminate uncertainty
Make the questions explicit. Never ask 'If yes, check this box'. Create a Yes and No question to eliminate any uncertainty.
2. Request data with required fields
Make use of a mandatory setting. With some eCRFs, you can require people to input data or answer questions. This can be useful to remind people to complete a field or to hinder subsequent data input. This can also eliminate deliberate or accidental missing data. Yet, forcing people to complete a field can be sketchy as well. If data is not available, it can be difficult to force a person to input any value. Thus, allowing people to mark certain fields as 'missing' or 'not available' can be beneficial.
3. Acquire more quantifiable and less irrelevant data
Avoid free-text questions and use pre-defined options instead. Free-text is difficult to quantify and requires data cleaning. You won't need to clean data if your forms are well-designed.
In most cases, a data collector, or a study coordinator already have an idea of the answers to expect. This knowledge should be utilized. One way is to use a multiple-choice question and define expected answers as possibilities. For cases where it's not applicable, one of the possibilities can be 'other' and you can use a text field to capture the applicable answer.
The remaining four principles are:
4. Acquire more quantifiable and less irrelevant data
5. Be lazy
6. Set your limits
7. Simple is better
Download your copy of our guide on how to design an electronic Case Report Form to see a thorough explanation of all 7 principles behind a good eCRF design.
It's important to note that these principles are not definite rules. They are a reference from our own experience working with medical device manufacturers and clinical research organizations.
Every study is different, and the complexity of data collection varies greatly from one to another.
However, keeping these principles in mind can help improve the overall efficiency, and lower costs of R&D - which leads to a shorter time to market.
With clinical investigations for Medical Devices as our sole focus for many years, we have developed an eCRF solution specifically engineered to handle the needs of the MedTech industry.
We are always ready to provide a customized and completely free demo of SMART-TRIAL to show you exactly how much you can reduce your data management workload. Contact us to see for yourself.