Electronic Data Capture Software:
Electronic Data Capture Software is a software that is used to store patient data collected in clinical trials in electronic form as opposed to paper form.
Information from documents and the internet can be collected and fed into appropriate business applications for further analysis.
Usually the electronic data capture software is web-based and utilizes a thin client. The software runs completely on a Web server and only an ordinary web browser is required that can be connected to the internet to access and utilize the EDC software. Clinical trial data is captured electronically at its source or in paper form and then transcribed into the EDC system later on and saved in an electronic case report form (eCRF). The EDC software is adopted mostly by sponsors, contract research organizations (CROs), and sites to carry out both simple and complex trials in all phases of research.
Features of Electronic Data Capture Software:
The most common features of an EDC system are:
- There are various design options to choose from that are meant to imitate paper forms while creating eCRFs. Forms are saved in a library and can be used across multiple protocols which eliminates the need to recreate commonly used forms and promotes data standards.
- Edit checks can be programmed to help prevent invalid data from being entered while building forms which ensures the values entered meet certain requirements.
- The data collected is entered into the appropriate forms after a protocol is set up in the software.
- Streamlined communication can be provided between monitors, data managers and coordinators. The software has auto-generated queries and the ability to manually add queries. However, all queries need to be responded to and resolved by different roles before the data can be locked.
- There are easily accessible exports to extract patient data when you want to to pull the data out of the software. Insights into the progress of a study can be provided by built-in metrics reporting.
Benefits of Electronic Data Capture Software:
You achieve success in the following ways by utilizing an EDC software:
- The software can help increase efficiency, ensure data quality, reduce the time and cost of clinical trials, and help meet regulatory compliance.
- Data collection can be streamlined by using EDC software.
- A significant amount of time can be saved with real time access to data and less time spent on query management which also saves time at the end of a study. This allow a quicker availability of the data for analysis.
- The software is is hosted online on a web-based interface with data entry completed. It can be ensured by the software vendors that the data is protected and backed up. As each user account has designated permissions, most of the actions can only be carried out by certain roles.
- The quality of data can be improved by providing accuracy as here are options to add constraints on a form that prevent inaccurate or illogical values from being entered. It only allows legible entries and automatic calculations for cleaner data. It can be ensured that the data meets certain required formats, ranges, etc. by edit checks before the data is accepted into the trial database.
- Efficiency of clinical trials can be increased due to its user friendly navigation. You can easily find and filter exactly what you need with the help of search option, and everything can be stored in one location with greater visibility while using less paper.
- It provides the process of clarifying data discrepancies with tools for identifying and resolving data issues with sites, and can help reduce the number of in-person site visits required during a trial.
- As the issues of efficiency and productivity can be addressed by the EDC software, the cost of clinical trials can be reduced.