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What Does Electronic Data Capture Or EDC Clinical Trials Mean?

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EDC Clinical Trials

What does Electronic Data Capture (EDC) mean?

Electronic data collection (EDC Clinical Trials) is the computerized collection and management of clinical trial data from patients and subjects. The EDC system uses technology to streamline the collection and transfer of clinical trial data from the patient to the research laboratory. This process reduces data errors and provides researchers with better data quality. In addition, it speeds up the entire process of clinical evaluation, thereby reducing research costs.

EDC Clinical Trials solutions are widely used for clinical trial and research purposes by clinical research organizations, the biotech and pharmaceutical industries, as well as for safety surveillance activities.

Techopedia explains Electronic Data Capture (EDC Clinical Trials)

Data from clinical trials at the source can be first recorded on paper and then entered into an electronic case report form or can be entered directly into an electronic case report form (eCRF). Another input procedure is an interactive voice response (IVR) system, where the patient reports information via telephone or point-of-contact data collection system. This is known as electronic patient reported outcomes (ePRO) and the data is captured using devices such as tablets or digital pens.

EDC Clinical Trials systems are either commercial, open source, or developed in-house. The system can be a stand-alone, server or multi-site, web-based system. Most systems have common features that allow for more efficient data collection, management and easy data exchange between different devices and systems. A typical EDC Clinical Trials system includes a graphical user interface for data entry, a data validation component, and a reporting tool.

Some common features of EDC Clinical Trials systems include:

  • Standard Electronic Case Reporting Forms (eCRFs)
  • Data entry with real-time data validation
  • Query management
  • Data audit trail
  • Check data changes
  • Data export
  • Multi-level user access
  • Generating a message

Benefits of EDC Clinical Trials systems

Clinical Trials

That include faster data access, data security, accurate and organized data, efficiency and cost-effective regulatory compliance. Web-based systems with online data collection forms enable real-time data collection and editing for multiple users and multiple locations.

Data Transfer Service Data

From external sources can be directly entered into REDCap projects via the Data Transfer Service (DTS). The process requires the user to map data fields from external sources to REDCap project fields. DTS regularly loads data from external sources into REDCap and makes the data available to project owners for review before saving to their projects.

Electronic Research Data Delivery Service

The Electronic Research Data Delivery (ERDD) service is available to researchers through an honest broker. The function of an honest broker is to deliver data from an identified database to researchers who have IRB-approved projects15.

The ERDD service allows CTR researchers to retrieve clinical data, including protected health information (PHI), from the Clinical Data Repository (CDR) system. The CDR system was implemented using an open source system called Informatics for Integrating Biology and Inpatient (i2b2)19 with the aim of secondary reuse of existing clinical data for CTR.

Researchers can use the system for cohort identification, retrospective data analysis, and hypothesis generation.

The CDR system has two databases:

De-identified and identified databases. CTR researchers have aggregate access to the de-identified database. The aggregate approach allows the researcher to query the de-identified database and generate patient counts based on inclusion and exclusion criteria.

Once a subset of data is identify for a CTR project, the researcher can apply to the IRB to obtain approval to download the data. An honest broker then obtains the data from i2b2 in electronic format and stores the data in a research database using the REDCap data import tool.

An honest broker performs the ERDD service in four steps. First, the data for the require query is exporte from the CDR system. Second, a CRF is creats in REDCap for all columns in the dataset. Third, the dataset is convert into a format that can be import into REDCap. Fourth, the dataset is import into REDCap.

Research Data Repository

Electronic Data Capture System

Research databases stores in the Research Data Repository (RDR), which is build on the MySQL database management system. Databases are design through the CRF electronic design module. All fields in the CRF have unique variable names within the project, and these are use to store data in the database as attribute-value pairs.

System security layer

The University of Missouri classifies PHI data (in compliance with HIPAA regulations) as Data Classification Level 4 (DCL4 – Highly Restricted)20. The EDC Clinical Trials system is secure by the DCL4 security layer, which is manage by the University of Missouri’s IT division.

System usage graphs of system usage for the past year (May 2013 to April 2014). Three graphs show: (a) number of users, (b) number of projects, and (c) page traffic. All graphs show linear growth of system utilization. Currently, the EDC Clinical Trials system hosts 64 projects and includes 102 users. A total of 43 projects are currently active, of which 19 are in production and 24 are in development. Of these 43 active projects, 35 projects contain survey tools.

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