Fundamentals of Electronic Data Capture in Clinical Trials

by Akanksha Sri Passionate in Blogging

Electronic Data Capture, popularly known as Electronic Case Report Form (eCRF) is a web-based software application that is helpful in the process of collecting, cleaning, transferring, and processing data required in clinical trials. The outcomes of a clinical trial majorly depend upon the data analysis and EDC assures that accurate data is produced in each study.

BENEFITS OF ELECTRONIC DATA CAPTURE IN CLINICAL STUDIES

EDC fast tracks the data collection process and streamlines the assemblage compared to paper-based techniques. EDC enables business organizations to capture the data efficiently and with a really fast processing speed.The data can be accessed from any system using EDC that avoids the hassle of writing and shipping paper forms. It even annuls the need for physical storage space to carry the data.The EDC platform promises data authenticity and integrity as advanced mechanisms are used to manage the data. Electronic Data Capture is highly protected and secured that there is almost zero threat of data theft involved.

HOW IS DATA CLEANED AND PROCESSED IN ELECTRONIC DATA CAPTURE?

Once the data is entered intothe web-based platform of EDC, it is identified, and missing or inconsistent information is corrected. This process is known as Data Cleaning which is usually performed by the data managers employed by the Clinical Research Organization in charge.

After the cleaning, the information is exported for further analysis. The data export mechanisms are integrated to generate datafiles in the form of statistical tools. The collected clinical information is then structured in datasets, details of which are documented beforehand.

The data is further processed and transformed using DMP- Data Management Plan. The EDC software is responsible for various advanced functionalities like automatic query mechanisms and the generation of custom reports.It also facilitates modules and coding for the medical terms and verifies the amplified data.

CHALLENGES RELATED TO ELECTRONIC DATA CAPTURE

The first and foremost barrier that comes in the way of firms getting associated with the electronic data capture system to plan its information is the high cost that comes with the adoption of this web structured software. Special staff needs to be hired for the working of the system and adequate training needs to be provided to them for the batching data entry and transformation. A high-class internet browser compatibility monitoring systemsneed to be set up to ensure a smooth flow of site functions. This becomes a hurdle for various CRO data managers and firms to embrace the technology.

CURRENT SCENARIO AND FUTURE OF ELECTRONIC DATA CAPTURE IN THE CLINICAL TRIAL STUDIES

Looking at the current scenario of the medical industry with the constant development both in terms of technology and durability of new equipment, the electronic shift in terms of undertaking real-time clinical trials is also taking place. The adaptation of electronic medical records allows researchers and clients to efficiently report the information about patients and the trial.

Currently, 20% of doctors and 10% of hospitals are using EDC and if the statistics are to be believed, these numbers are constantly rising. In clinical trials, EDC is currently being used to keep track of the subject outcomes that allow the industry to efficiently share subject case history between sponsors, clinical investigators, and big data management units for keeping a check of the proper flow of data. The real-time analysis and review of the clinical trials are made possible with the contagious use of such a deemed software. Furthermore, the significant problems that are created with the use of the EDC system for the clinical trial, are being paid more attention to by thoroughly planning and monitoring the databases and structure systems. The importance of transparency and efficacy related to the EDC issues by updating the guidance document is being evolved and therefore the firms are increasingly adopting this system.