Data Integration
The Data Coordinating Resource Center at the University of Utah has significant accomplishments in the arena of data integration for the HEAL ERN trials. In the current clinical trial landscape where decentralized trials, technology and phone applications for treatment delivery/data capture, and collaboration amongst very unique institutions and vendors are becoming the norm, a new expertise amongst data coordinating centers is needed. It is imperative that the data coordinating center can integrate data from multiple sources within a time frame and frequency that allows the study to succeed. Over the course of the HEAL ERN trials, the DCRC has successfully implemented multiple methodologies to integrate data from external smart phone and web-based applications, Veteran’s Affairs based data capture systems, and collaborating institution’s applications and/or warehouses. In the PRESENCE study, for example, the DCRC has balanced two unique strategies simultaneously.
- Involves our more common workflow wherein an external source sends all data needed for analysis via secure file transfer protocol (sFTP). Subsequently, the sharing of safety and analytical data with the SSRC is done via sFTP at scheduled timepoints or frequencies.
- Includes real-time data transfer from the android/apple phone application directly to our REDCap project via API calls and posts. Subsequently, all REDCap data is imported into the DCRC’s data warehouse. This method allows for two-way communication between DCRC systems and the study’s proprietary phone application.
CDE Program
The NIH HEAL Common Data Elements Program is designed to facilitate cross-study comparisons within HEAL research, enabling secondary analyses that enhance the interpretability of findings. By standardizing data elements, particularly for patient-reported outcomes (PROs), pain research grantees who study human subjects can collaborate more effectively and draw more meaningful insights from their data. The HEAL CDE team at the Utah DCC supports the national HEAL CDE program via programmatic support to NIH leadership. CDE development began in the pain arm, with human-focused pain management studies. The initiative is currently extending to the HEAL opioid/substance use arm. The Utah DCC team develops 508-compliant case report forms (CRFs) and common data element specifications for HEAL instruments; and interfaces with the overarching HEAL data ecosystem to leverage common data element metadata. Utah DCC-based project managers provide information and assistance to newly funded HEAL investigators to ensure that study teams are aware of the HEAL CDE Program and are using required core measures; and help teams to identify existing instruments/ CDEs among the supplemental measures. They track copyright license procurement; and track what questionnaires are used by which studies. Additionally, the team provides ongoing technical assistance to study teams and HEAL data coordinating centers. As a Principal Investigator of HEAL ERN, Dr. Sward oversees the Utah DCC support to the HEAL CDE program. With her expertise in biomedical informatics, Dr. Sward serves as a crucial communication link with key stakeholders, provides program oversight, and guides the program's strategic direction.