The implementation of robust data management infrastructure has become critical for modern clinical and translational research. This article discusses the development of a customized electronic data capture (EDC) and research data repository system catered for multi-site, multi-study clinical research. The system comprises dedicated modules for user account and access management, workflow-based study build with EDC clinical trials functionalities, centralized data storage, and advanced data retrieval and analytics functionalities.
Additional features including study data dashboards, real-time report generation, and built-in validations further augment the system’s capabilities. By facilitating seamless data capture, systematic data storage, efficient data extraction and exchange, and promoting FAIR data stewardship principles, this system enables the conduct of integrated, large-scale, collaborative EDC clinical study while ensuring optimal data quality and promoting secondary research data usage.
Introduction
The adoption of electronic solutions has become pivotal to improving efficiency, data quality, cost-effectiveness and compliance in clinical research settings compared to traditional paper-based methods. This has spurred the utilization of electronic data capture clinical trials systems which facilitate direct data collection and management functions through web-based platforms. Concurrently, the conception of centralized repositories that systematically store study data for present and future usage also holds tremendous value. However, considerable heterogeneity exists in the functionalities of such existing systems.
Recognizing this technology gap, there have been continuous efforts to develop cutting-edge, customized platforms that can comprehensively serve various EDC in clinical research needs.
This article discusses the successful development and usage of an integrated electronic platform that delivers robust electronic data capture functionalities for multi-center clinical trials along with the ability to store, manage, and retrieve study data assets in a centralized data repository.
By synergizing critical components of clinical data workflows under one umbrella, this system aims to promote high-quality, integrated clinical research that abides by FAIR (Findable, Accessible, Interoperable, and Reusable) data stewardship principles.
System Implementation
The system utilizes a modular architecture built primarily using open-source technologies that integrates two major components
1) The Electronic Data Capture System and
2) The Research Data Repository.
This allows combining a versatile EDC Data Capture engine with systematic post-trial data archival abilities. Critical system features are discussed below:
Electronic Data Capture System
This module focuses on providing specialized electronic data capture, management and monitoring capacities for multi-center clinical trials encompassing diverse therapeutic areas. Core functionalities include:
User Account and Access Management
- Identity management using LDAP/Active Directory Server Integration
- Configurable user roles and permissions settings
- Audit trail tracking
Research Electronic Data Capture
- Intuitive graphical study builder with drag-and-drop question modules
- Support for complex data capture scenarios via branching logic
- Custom report builder with templated and ad-hoc reporting
- Real-time study metrics and dashboard for monitoring
Additionally, specialized modules for patient randomization, supply management, and imaging upload have also been incorporated. The workflow-based builder allows clinicians and researchers to efficiently create EDC frameworks tailored for their specific study needs.
Key EDC System Tools and Features
| Feature | Description |
| Study Builder | Intuitive drag and drop builder to construct data capture workflows |
| Access Control | Granular user permissions and access settings |
| Data Validation | Configurable validity checks and range restrictions |
| Audit Logs | Complete activity trail for data modifications |
Electronic Research Data Delivery Service
This add-on component facilitates seamless data extraction and exchange from the EDC database to external parties in non-proprietary formats, promoting interoperability.
Research Data Repository
This module focuses on the systematic post-trial archival of study data assets for long-term storage and future reuse. Salient features include:
- Web-based data uploader with file characterization
- Custom metadata standards for describing datasets
- Assignment of unique Digital Object Identifiers
- Controlled access integrations for data consumers
- FAIR data principles compliant data storage
Together with the data delivery service, this archived study data can be efficiently retrieved for secondary research purposes with appropriate access controls.
System Security Layer
Rigorous enterprise-grade security measures have been implemented spanning both physical and digital domains to secure overall system integrity and guard against potential threats. This is enabled via state-of-the-art firewalls, encryptions, redundancy models and routine penetration testing exercises.
System Usage and Discussion
Since its inception, 500+ studies have been hosted on this versatile platform and over 275,000 patients have been registered across diverse therapeutic indications – oncology, cardiology, ophthalmology etc. The centralized data repository currently archives over 650 data assets potentially enabling their long-term preservation and reuse.
Both clinician users and administrators have provided favourable feedback, applauding the convenience of workflow customizations for capturing relevant parameters. Automated data validations and integrity checks have significantly reduced queries, minimising post-cleanup efforts. Centralized access to real-time reports and dashboards has facilitated rapid decision making. From an administrator standpoint, the ability to track detailed audit logs to identify irregular system usage has bolstered overall compliance. There have also been no reported system downtimes till date.
Researchers accessing the repository data via the self-service portal have found the experience to be highly convenient aided by the wealth of indexed metadata. The adoption of non-proprietary and open standards around data and metadata specifications has enhanced interoperability allowing usage across platforms. Access request procedures were also found to be smooth and rapid.
Conclusion
This innovative data management platform has demonstrated immense utilities in supporting end-to-end clinical research data workflows spanning capture, storage, exchange and reuse. Its versatile electronic data capture system paired with a state-of-the-art FAIR data repository has served as an excellent prototype that can fulfill diverse functional expectations from modern clinical research systems.
As clinical trials and digital methods continue to intersect, adoption of such specialized platforms can profoundly transform research processes.
FAQs
Q: Can external parties access repository data easily?
A: Yes, external qualified researchers can securely access archived deidentified study data by submitting access requests via the portal. Metadata assists them in identifying suitable datasets.
Q: Does this system support observational studies beyond clinical trials?
A: Certainly, while the system has catered primarily for regulated clinical trials so far, with slight configuration tweaks it can also facilitate complex observational study data capture workflows in the future.
Q: What are the storage and backup provisions in place?
A: All repository data is stored on high redundancy enterprise network attached storage solutions with scheduled encrypted offsite backups to guard against disasters.
