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How Optimized eCRF Design Leads To Quality Clinical Trial Outcomes

Clinical trials are extremely important in the field of health and medicine. These examinations lead to the development of cures, new drugs, and the like that lead to better health systems, longer lifespans, and improved quality of living. 

If you’re a clinical trial professional, it’s best to keep in mind that you’ll need to have accurate and reliable data to help you draw sound conclusions for successful clinical trial runs. You’ll collect this data from the general public or those suffering from a given disease – all of which are chosen respondents of a particular trial. Those who’ll participate in the process are commonly referred to as patients. To collect crucial clinical trial data, the patients need to fill out Case Report Forms (CRFs.) 

With digitization, there’s been an upgrade of documents like CRFs in clinical trials, such that patients can fill their data electronically. Here, they’re referred to as Electronic Case Report Forms (eCRFs.) After its use, experts agree that ECRFs have brought about quality in clinical trial outcomes. Are you wondering how? Read on to find out how they’re doing this.

ECRF design leads to quality trials by: 

Eliminating Manual Data Entry

As the name suggests, eCRF is an electronic system, meaning there will be no manual data entry for both the patients and your data analysts. This is beneficial because manual data entry is believed to be one of the primary sources of errors in clinical trials data collection.  

The eCRF system can notify patients of errors they make during data entry. However, this is only possible if you set your eCRF only to accept a given data format during the filling-in process. Should a patient fill in data incorrectly, it’ll notify them by informing them of what you accept. Alternatively, it won’t accept the submission request from the patient. The system will highlight the problematic area to direct the patient to where the error is.

On the other hand, with manual CRF, your team has to manually feed in the data from the forms to your systems. There could be cases of double-entry, missed entries, or input of wrong numbers. All these affect the quality of your clinical trial. Nonetheless, with eCRF, these errors are non-existent which leads to quality results.

Enhancing Data Analysis

Data analysis is often the lengthiest process of a clinical trial. 

Your team has to consolidate all the data into their right categories and cleanse them before beginning the analysis. The whole process, including data gathering, is very taxing for your personnel and fatigue is oftentimes attributed to errors in clinical trials. They’ll not be as keen when they’re tired and might compromise some aspects to get done with the work and move to the next. Data collected in such a manner will lead to poor quality results that lead to wrong conclusions in your trial.

An eCRF ensures there’s less human manipulation of your clinical data. With patients filling in data electronically, there’s no need for manual data transfer. All your analysts need to do is copy and paste data into the needed fields. 

As previously stated, there will be fewer errors from patients as they fill in the forms. Thus, there will be less data cleansing. After the cleansing, there’s software that’ll group the data accordingly. In the end, your team’s main focus will be on the analysis itself. They’re better focused with less workload, leading to quality in your clinical trial.

Giving You Control Of Your Data

During a clinical trial, you want to have total control of the data you’re collecting to ensure you get what you need. But this isn’t always possible with manual CRF systems. The patients can input data incorrectly or give you data you don’t need, and you barely have control of this. You won’t have quality data to rely on for your trial analysis at the end of it all.  

Yet an optimized eCRF tool design changes the narrative by giving you control of the data collection process. 

During data collection, you’ll collect important and less important data. In most cases, your clinical trial can’t be a success without the important data. eCRF enables you to include mandatory fields on your report form. Include this in the essential data of your trial. 

With mandatory fields, your patients have to fill them to complete the process successfully. You’ll get all the data you need to make conclusive results on your clinical trial through the mandatory sections, ensuring quality. Nevertheless, refrain from having all the sections mandatory. Give room for your patients to choose what not to answer. It’ll make them feel they have some control of the process. 


The discussion above has shed light on various aspects of eCRFs. One of these aspects is how they’ve impacted the quality of clinical trials. With this information, you’re better placed to decide whether to adopt eCRF in your clinical trials. The decision is yours to make. Even so, be sure to make the right decision that’ll benefit all parties involved, including the public relying on you to make medical advancements.