Clinical Data Management & Reporting for Research

For researchers, clinical data management and reporting has historically included manual curation and compilation of datasets from disparate data warehouses. In today’s data-rich environment, manual processing and integration is becoming more and more of a bottleneck. In order to keep up with the increasing amount of data collected from clinical research, clinicians and statisticians alike need software tools that will centralize their data and help them quickly recognize errors. This makes adopting software solutions like clinical data management systems (CDMS) critical to the integrity and longevity of research in order to experience these benefits:

 

Contents: Data Integrity | Data Integration and Capture | Reporting and Collaboration | Choosing a CDMS | LabKey CDMS

 

Maintaining Clinical Data Integrity

Having an accurate representation of clinical data helps transform discoveries and understanding into patient care and treatment. Centrally-housing data in a compliant environment that enforces data standardization can help clinicians maintain excellent data integrity and provide an authoritative view of their data landscape.

Integration of Data from Multiple Sources

Bringing together data from disparate sources into a single system can help clinical research stay on track and on time. Collaborative monitoring of data quality by clinicians, statisticians, and scientists enables quick identification of erroneous data and ensures a reliable, integrated data landscape for comprehensive data analysis.

Clinical Data Capture & Alignment

Effective clinical data management and reporting requires the seamless integration and alignment of data from various sources with tools like data validation, ontology vocabulary enforcement, and automated data capture methods like ETL. This should include direct integrations with Electronic Data Capturing systems like REDCap.

Secure Clinical Reporting and Collaboration

A key component of effective clinical data management is the ability to share reports and data with collaborators to improve research, innovation, and ultimately patient care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in clinical research where patient safety and care is the top priority.

Choosing the Right CDMS

A clinical data management system can help researchers organize their data management approach. When selecting a CDMS for a clinical study or trial, it is important to consider the following factors:

• Scalability: Ensure the system can grow with your needs and handle increasing volumes of data.
• Flexibility: Look for solutions that offer customizable workflows and integration options to fit your specific requirements.
• User-Friendliness: The system should be easy to use, with intuitive interfaces and comprehensive support and training resources.
• Support and Maintenance: Consider the level of support and maintenance offered by the vendor, as this can significantly impact your long-term satisfaction with the system.
• Data Connectivity: Evaluate the CDMS’s ability to integrate with other essential systems such as electronic health records (EHRs), laboratory information management systems (LIMS), and external data sources. Seamless integration is crucial for maintaining a comprehensive and unified data repository.

LabKey CDMS

LabKey CDMS provides essential tools for clinical data management to overcome these, and other key clinical research challenges.

LabKey CDMS helps maintain data integrity by providing:

• A highly structured data environment with enforceable data fields to ensure data is entered correctly and within range
• Quality control measures such as data flags, QC of datasets and built-in QC reports
• Role and group-based permission levels that allow users only access to what they need access to
• A compliance module, the allows users to set PHI securities, set Terms of Use for users, and provide electronic signatures on data snapshots

LabKey CDMS helps facilitate comprehensive data integration by providing:

• Management of lab data together with clinical data in a single system
• A study module that can recognize and integrate disparate vendor datasets
• Built-in and customizable integration with electronic data capture systems and case report forms
• A clinical document abstraction pipeline, which can extract valuable data from legacy documents

CDMS improves reporting and collaboration by providing:

• Dynamic and static reporting tables and visualizations that can be shared as-needed
• Web-based access to a central platform for data sharing
• The ability to remove PHI fields or provide randomized IDs when sharing information with collaborators

With the right tools for clinical data management, research teams can eliminate data integration bottle necks and curate reliable datasets for analysis. Explore our example Longitudinal Study  or view our product page to see how LabKey CDMS can help your team overcome these, and other common clinical research challenges.

Related Documentation

Read more about the features highlighted above on the LabKey Support Portal:

• Data Quality Control
• Security & Permissions
• Compliance Module
• Longitudinal Study Tools
• File Watchers – Automated Directory Monitoring
• Clinical Document Abstraction