Improving Clinical Research Data Quality With Electronic Data Capture

An increasing number of clinical research groups and independent investigators turn to electronic data capture to ensure accuracy and precision in their studies. The seemingly simple processes of gathering, encoding, and analyzing clinical data involving humans need to be errorless because they deal with findings pertaining to new medicines, medical treatments, and hospital machines.

An electronic data capture (EDC) system is basically a system that gathers and saves data from clinical trials electronically. Some researchers who use EDC still use paper to jot down data before encoding them into the system. Recent developments have allowed researchers to directly key in records into the electronic system.

An EDC has three essential components:

– A user interface to input numbers, names, records, and statistics

– A confirmation tool to corroborate the data entered by the user

– A reporting device to analyze and interpret the data

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The EDC is used by hospitals as well as clinics in schools and offices because they serve as the sites from where the findings are taken. The findings that are transcribed, tabulated, and interpreted by research organizations will be forwarded to involved companies which are regarded as sponsors.

A sponsor of a clinical trial could be a biopharmaceutical corporation or a life science company. Such businesses need findings about their products and services in order to get the necessary certifications from the government and other licensing agencies.

The clinical data solutions that EDC offers

While some EDC users still use paper while collecting initial findings, others have completely embraced working with electronic formats. The disuse of paper in the process of clinical data gathering has become beneficial because it saves a great deal of time when data is directly entered into an EDC system.

More time and money are saved when the data are electronically sent to the researchers and sponsors. Gone are the days when paper forms had to be transported from the site to the research group and then to the sponsor.

Employing an EDC system has even been made more convenient because it can now run on a web server by just using a regular browser. Early EDC users had to install their clinical trial software in their hardware and have additional plug-ins.

Using EDC for clinical data management

One of the greatest advantages of using the EDC over its paper-based process is that the clinical data can be filtered and edited on the spot via a clinical trial management system. Errors in transcriptions and encoded data can be remedied at the clinic or hospital even before they get sent to a research organization or sponsor company.

The most common clinical data management components are:

– Editing tools which can check the ranges and formats of data before they are entered into a database

– Filtering tools which can highlight certain aspects of findings to be used for a specific study

– Storage tools to keep the contact information of respondents

– Scheduling tools to monitor highlights and due dates

– Data clarifying tools to spot inconsistencies and irregularities especially if the data came from paper forms

– Compliance tools to make the data format abide by policies set by the government and other concerned agencies

– Calculation tools to easily compute and fill in encoded formulas

– Search tools to locate pieces of information easily

Users of clinical trial management software are also able to oversee performing functions, direct financial accounting, and manage patients and investigators.

Personalizing eClinical solutions

The EDC system and clinical trial management software are readily available for purchase from vendors while some software systems are even offered for free. Some groups, on the other hand, have chosen to spend more by building their own systems to include their specifications and other requirements.

An in-house EDC and data management system can involve exclusive data filters and customized formats. Companies can also choose to include drag-and-drop or point-and-click modules.

Whether downloaded, purchased, or personalized, eClinical solutions are worthy investments because they are instrumental in the efficiency of collecting, encoding, and interpreting data. The findings are sure to be private because an online database can be secured with a password. Electronic data can also be backed up without difficulty.

Those who are accustomed to using pen and paper for clinical data trials may have a hard time adjusting to the EDC. But they will not have a difficult time for too long because the EDC system is user-friendly. They will soon realize that the EDC has everything they need and that they can perform all their transcribing, encoding, formatting, and analyzing duties in just one sitting with improved quality, accuracy, and efficacy.

Sources:

Lopienski, Kristina (2016, February 2). The Beginners Guide to an Electronic Data Capture (EDC) System. Retrieved from http://forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system/

Fundamental Aspects of Electronic Data Capture (2016, August 26). Retrieved from https://www.openclinica.com/electronic_data_capture/

Electronic data capture. (2016, August 2). Retrieved from https://en.wikipedia.org/wiki/Electronic_data_capture

Clinical trial management system. (2016, August 14). Retrieved from
https://en.wikipedia.org/wiki/Clinical_trial_management_system