13 - Working Toward a Unified DoD Research Solution for Standardized Informatics Electronic Data Capture and Study Management: Lessons Learnt and Best Practices.

Abstract Text:

Objective: Clinical trials are critical to address gaps within the Military Health System in the treatment of service members who have sustained a Traumatic Brain Injury (TBI). Such research generates large amounts of data, and associated regulatory burden for security, access and storage. To improve efficiency and effectiveness, we have developed and implemented an informatics platform. In this work we present important lessons learnt on protocol setup, assessment creation, subject management, regulatory compliance, and end-to-end support of the clinical trials lifecycle (planning to execution to close-out), on our unique platform. These topics are critical to address an outstanding, and important area of need within the DoD and fills a unique void.

Materials and

Methods: We have developed a standardized informatics framework through the
CNRM Collection Access Sharing and Analytics (CASA) platform. At the core, the CASA platform is built on the NIH BRICS system however, there are several important integrated tools for clinical trials: full audit capabilities, samples tracking and management, offline capture, remote data collection, integrated patient management, data dictionary and real-time data access to support user friendly informatics capabilities. In addition, inbuilt end-points for analysis using R and Jupyter Notebook are available in the CASA platform. The CASA platform has been refined with agile evolving features to meet new and future demands of research.

Results: The CASA platform has been successfully deployed to support a variety of active DoD
funded clinical trials ranging from sleep disorders, chronic migraine, and PTSD involving
service members; across multiple military treatment facilities. In-built resiliency within the system have provided uninterrupted data collection and monitoring through secure remote modules. We outline a series of best practices based on practical lessons learnt for protocol development, selection of data elements based on DoD-NIH common data elements, formation and regulatory compliance, study management and execution across multiple military treatment facilities. We also highlight the associated meta data, tools and processes to support data sharing using CASA, the CNRM Informatics Data Repository and the Federal Interagency TBI Repository (FITBIR).

Discussion: The practical development and implementation of a standardized informatics platform has provided valuable lessons learnt. Disseminating this information as a framework for planning and designing clinical trials research including protocol start up, multi-site research, subject and study management is valuable for future investigators within the DoD network. In addition, the standardized informatics tools developed provides an explicit process for data regulatory compliance, monitoring, curation and sharing, with a well-documented data dictionary; features that promote data sharing and serve to accelerate translational therapeutics and cross validation of research findings.

Keywords: informatics, clinical trials research, regulatory compliance, electronic data capture, digital therapeutics