TITLE: Clinical trial data and eCRF systems

While recording trial results on the carbon paper is slowly vanishing, the electronic data capture prevails. The information gathered from a patient during a clinical trial is input into a case report form (CRF). All those CRFs are stored in so-called electronic data capture (EDC) system that ensures convenient data management for clinical trial projects.

 

What is an eCRF?

Basically, an eCRF is the electronic case report form used for recording patient data. Before each clinical trial starts, its managers and workers have to spend some time elaborating on the CRFs. Such forms should contain all the necessary data to make clear outcomes of the study, so taking lots of details into consideration takes place.

 

The design of eCRF before the start of each clinical trial might take months, though it takes considerably less time with the EDC system. The design of report forms in the eCRF system is much faster because there are general templates along with the worksheets from previous studies that are already in place. Using them as a basis helps to save lots of time for the eCRF design before the clinical trial starts.

What are the benefits associated with eCRFs?

Apart from the speed at which the report forms are created, the digitalization of clinical trial records has lots of other advantages. Those range from a better quality of data entered to the overall management of the clinical trial projects.

Data accuracy

During the eCRF design, many aspects are taken into consideration, and data accuracy is one of them. When creating the form fields for the patient data or clinical observations, the system performs automatic checks for the data accuracy. This means that the system detects whether the information entered matches the required data type. For instance, only the numbers from 0 to 9 should be allowed for use in the age field.

Data availability

Once the EDC system is implemented, the clinical trial personnel obtains access to it. As such systems also provide cloud-based solutions, the data becomes available to other medical workers with proper access rights even though they are in another city. Thus the implementation of the eCRF system makes data sharable and available to other professionals when needed.

 

Data processing

Another strong benefit of the data in the EDC system is its organization and processing. Once the data is entered into the EDC system, a comprehensive analysis and reporting can be made based on it.

Data security

Even though there sometimes might be doubts about data security in electronic systems, medical software is always paid much attention in terms of data protection. It means that additional safety measures and technological solutions are implemented. One of those is the two-factor authorization that requires a personal mobile device to be used to access the system.

Data integration

The data entered into the EDC system can be further re-integrated into clinical trial data management systems. Those are more complex solutions that not only simplify the data recording but ensure an advanced management process of the entire clinical trial.