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How Electronic Data Capture Improves Data Quality In Clinical Research Studies

Electronic Data Capture or EDC is a result of advancements in technology over the years. Clinical research organizations medical investigators, like your company, will benefit from this data collection software.

EDC is software that stores data collected in electronic form. It streamlines the data collection process. This eClinical Solutions software is widely used by pharmaceutical companies to determine which drugs and medicine to develop. EDC is also useful for other life science organizations, like those in biotechnology and medical device industries.

Clinical Data Management Provisions

The EDC system provides the following:

- Graphical interface component for easier data entry process.

- Validation component to check accuracy.

- Reporting component for analysis.

The system has a high start-up cost, though. First time users encounter difficulties in the implementation because of the lack of knowledge and proper orientation about the system. One of the common mistakes most companies commit is having an initial design of study using EDC which does not result in the decrease in the expenses during the study. Poor planning often results to costs higher than previously projected.

With several innovations, clinical management systems have allayed fears of most organizations. Two of the most recent changes that benefit users are the availability of point-and-click and drag-and-drop design modules.

Clinical Data Solutions

How EDC Works

Electronical Data Capture begins with the recording of data on paper (form). The data is then transcribed into the clinical trial management system. Lastly, it is saved in an eCRF or Electronic Case Report Form. Check out the video to learn more:

Benefits of Using EDC

- Allows quicker access to collected data.

Saves time and provides real-time access to patient data, allowing for lesser time spent in query management. Data becomes easily available for analysis.

- Ensures security of data.

The clinical trial software is hosted online; hence, data entry is done on a web-based user interface. Individual accounts cannot be accessed due to designated permissions, ensuring file safety of the files. Back-up options are available, as well.

- Improves data accuracy.

Manual entries on paper are prone to errors, with the EDC software, the quality of data is ensured. Data collection and entry is automated, hence, you get legible entries and cleaner data.

- Easier organization of clinical trial data.

The software offers user-friendly navigation, resulting in the efficiency of clinical trial process. It is easier to find and filter the data you need with the simple search options. Data is stored in a single location, for easier retrieval and greater visibility. As a bonus, you get to reduce costs on office supplies particularly paper and you do your part in preserving the environment.

- Cost-effective.

It will be an expensive investment for your company, but the system becomes cost-effective in the long run. Start-ups are always the most expensive, but if you do it right, youll reap the results in time.

- Ensure your companys compliance

There are regulatory requirements that your organization need to meet and the software should have technical controls in place. This ensures the integrity of the data collected. The software vendors would be able to help you with the process.

Key Features of the Clinical Trial Management Software

- eCRF

There are different design formats to choose from. The eCRF is patterned after the paper forms you have been using. These forms are saved in a library, and accessible across multiple protocols.

This eliminates the production of commonly used forms. It also promotes data standards that will be used for all researches and studies. Edit checks are provided to ensure that you dont get invalid data.

- Data Entry Interface

The data you collected is encoded in appropriate forms.

- Query Management Interface

For most systems, queries are auto-generated, but manual entry of queries is allowed. EDC allows for streamlined communication between data managers, coordinators, and the monitoring team.

All queries should be responded to and resolved before data is locked and stored in the designated library.

- Data Export Option

This feature allows you to pull-out data from the system easily. The built-in metrics reporting interface provides information on the progress of the clinical trial.

Users of EDC

- Sites - it is the entity that collects data (hospital or clinic)

- Sponsor - the owner of the clinical trial, the one that commissioned the research

- CRO - the Contract Research Organization. It contracts the sponsors for the planning and actual clinical trial process

There are three main benefits of using EDC for clinical research studies:

- Improves the quality of data

- Speeds up time of analysis and submission

- Faster turnaround time means faster approval

The Electronic Data Capture software provides a process to electronically collect data, for faster analysis, and reporting. Users can leverage technology to improve the quality of data collection. EDC minimizes generating problematic and incomplete data.

References:

Electronic Data Capture.Wikipedia.Retrieved Sept. 6, 2016, from https://en.wikipedia.org/wiki/Electronic_data_capture

Lopienski, K.The Beginners Guide to an Electronic Data Capture (EDC) System.Forte Research Systems.Retrieved Sept. 6, 2016, from http://forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system/

Fundamental Aspects of Electronic Data Capture.Open Clinica.Retrieved Sept. 6, 2016, from https://www.openclinica.com/electronic_data_capture/

Schwartz, M.Data Quality in Electronic Data Capture Based Clinical Studies.MedNet Solutions. Retrieved Sept. 6, 2016, from http://www.mednetstudy.com/data-quality-in-electronic-data-capture-based-clinical-studies/