Electronic Data Capture Fundamentals
Let’s jump in and learn:
What is Electronic Data Capture (EDC)?
Electronic data capture (EDC) is the digital collection and management of clinical trial data related to patients and safety. It is widely used in the biotechnology and pharmaceutical industries and clinical research organizations through electronic data capture systems.
These applications streamline the collection of clinical trial data from patients as well as related information from labs and other sources. Information stored in electronic data capture systems is digitally transferred to research labs for analysis or added to clinical trial databases that gather data from many clinical studies.
Most electronic data capture systems provide an interface with a menu of options for most fields based on standards defined by the Clinical Data Interchange Standards Consortium (CDISC). This reduces data errors and provides researchers with improved data quality by enforcing consistency of terminology across patient records and studies.
Electronic data capture systems are used to capture many different types of clinical trial data, such as data that is:
- Collected during clinical trials about patient status and conditions
- Related to safety in clinical trials
- Test results from labs or other healthcare providers
- Information from patients (e.g., pain levels, quality of life, mobility)
- Patient information recorded by apps and devices (e.g., blood glucose monitors, blood pressure monitors, wearables)
Considerations when evaluating an electronic data capture solution include:
- Operational capabilities—the features, functions, and sheer power to manage the volume of data produced
- Pricing—the cost for using the solution as well as the pricing model, such as licensing, subscriptions, pay-as-you-go, or pay-per-protocol
- Implementation—the requirements to get the system up and running and to establish bi-directional data integration with existing sources
- Ease of use and support—the accessibility and intuitiveness from an end user’s perspective along with online and live support services as required
- Security—the system supports compliance with key regulatory requirements, such as HIPAA and 21 CFR Part 11
Who Uses Electronic Data Capture Systems?
The primary groups that use electronic data capture systems are organizations that run or work with clinical studies. This includes:
- Clinical trial sponsors
- Contract research organizations
- Study coordinators
- Physicians
- Research laboratories
These groups use electronic data capture systems to collect study-related data such as:
- Patient outcomes
- Laboratory test results
- Medication use
- Adverse events
- Patient-reported outcomes
They also use electronic data capture systems to:
- Coordinate data collection from various sites (e.g., clinics, hospitals) and sources (e.g., labs, patients’ wearable devices)
- Track trial progress
- Monitor site compliance
- Query data
- Create reports
- Transmit data to other systems
Key Features of EDC Systems
Electronic data capture systems include a number of powerful features such as:
- Capability to generate standard and custom reports
- Data audit trail
- Data entry capabilities that include a validation component that flags errors, such as out-of-range values or incorrect codes
- Double data entry (DDE) capability for paper and hybrid studies
- Edit checks limit the entry of incomplete data fields
- Integration of CDISC standards to ensure interoperability throughout the lifecycle of the study
- Multi-level user access controls
- Numerical data validation that detects and stops the entry of data that is out of range for a specific field
- Query management
- Risk-based monitoring
- Secure data export, transmission, and storage capabilities
- Standardized coding (e.g., WHODrug and MedDRA)
Additional components that are often included in electronic data capture systems include:
- Clinical trial management system (CTMS) software
- Electronic case report forms (eCRF)
- Interactive Web response system (IWRS)
- Patient-reported outcome (PRO) software
- Subject randomization and drug management system
Benefits of Electronic Data Capture Software
- Ability to implement any level of security for transfer, storage, and access control systems
- Audit functions track and record all access and changes made to patient records providing a robust audit trail for internal and regulatory compliance requirements
- Built-in edit checks catch many data entry mistakes and ensure all fields are complete
- Data quality is improved by minimizing the introduction of errors when data is transferred from paper to digital records
- Efficient data capture reduces delays by eliminating the need for completed forms to be securely delivered and processed by data entry teams
- Faster accumulation and secure transfer of data between systems and users
- Filters make it fast and easy to find the required information
- Increased statistical power with higher quality data
- Online data collection forms allow real-time, multi-user, multi-site data collection, and editing
- Overall reduction in the costs and time involved for studies
- Real-time data access improves study management and monitoring—trial teams, monitors, and auditors can access whatever data they need from wherever and whenever they want
- Reporting capabilities allow authorized personnel to access, download, and print reports throughout the study and on completion
- Robust data analysis can be run with eCRF information
- Study data can easily be shared with clinical trial databases
Trends in Electronic Data Capture
In addition to ongoing work on core features, trends in electronic data capture are primarily focused on the expansion of existing functionality and taking advantage of new capabilities as the systems continue to evolve. These trends in electronic data capture systems include the following:
- Expansion of functionality to improve the uniformity of data capture
- Increased focus on patient safety
- Shift toward more patient-centricity studies
- Acceleration of clinical trials
- Additional sources of data, especially information available from wearables
- Wide use of artificial intelligence in data analysis and clinical trial management (e.g., risk-based monitoring, patient recruitment, adaptive randomization methods)
- Interoperability enhancements that streamline integration with other systems, such as eCRF, safety, CTMS, eTMF, coding, event reporting, supply management, and randomization software
- Digital data collection (e.g., wearables, ePRO)
Electronic Data Capture Clinical Efficiency and Compliance
The case for electronic data capture systems from an operational perspective is clear. Electronic data capture systems improve information management and analysis, accelerate the timeline for clinical trial approval, and enhance the power and reach of clinical data for research.
Electronic data capture systems have the added benefit of playing a significant role in meeting and maintaining compliance with regulatory requirements, which reduces delays that can slow time for pharmaceuticals to become commercially available. Most electronic data capture systems use audit trails and secure signatures to support 21 CFR Part 11 validation and compliance requirements. In addition, most electronic data capture systems use encryption, access control, and other security measures to protect patient health information (PHI) and meet the compliance requirements of HIPAA.
Egnyte has experts ready to answer your questions. For more than a decade, Egnyte has helped more than 16,000 customers with millions of customers worldwide.
Last Updated: 23rd November, 2021
