USAMRMC Releases IT Solutions for Clinical Trial Management
The U.S. Army Medical Research and Materiel Command Enterprise Information Technology Project Management Office released an innovative IT solutions product for clinical trial management.
In August, collaborating with the U.S. Army Medical Materiel Development Activity Clinical Operations Branch, eIT PMO released the Clinical Trial Management System. The CTMS is an enterprise-level system for enhanced management capability for Office of the Surgeon General sponsored clinical trials. It enables improved executive visibility, concise trial monitoring, and enhanced tracking and reporting of protocol activities.
"The CTMS is an automated, centralized web-based system that fills a USAMRMC gap that no single system collects and integrates required clinical trial information in which to manage the overall clinical trial process worldwide," said USAMMDA Chief of Clinical Operations Melissa Askin.
eIT PMO provides and sustains a suite of USAMRMC Medical Research Enterprise information management and technology solutions. These solutions meet the needs of the command and collaborators by:
- Facilitating full program coordination, planning, management and execution to ensure successful acquisition of required medical research IT solutions.
- Procuring, configuring and sustaining IT solutions for USAMRMC's medical research activities in accordance with Department of Defense, U.S. Food and Drug Administration and U.S. Army Medical Command policies and regulations.
- Coordinating, with the USAMRMC, Medical Research Functional Sponsors in the prioritization and implementation of IT solutions throughout the USAMRMC.
eIT PMO products comply with the overarching, ongoing requirement of the FDA Part 11, Title 21 of the Code of Federal Regulations for Electronic Records; Electronic Signatures (21 CFR Part 11). In addition to CTMS, the eIT PMO product suite delivers these mission essential capabilities:
- The Electronic Document Management System delivers electronic document management and electronic signature capability for FDA regulated and Research Management Enterprise non-regulated activities across the USAMRMC.
- Serious Adverse Event provides electronic storage and automation for serious adverse event management/reporting.
- Electronic Data Capture - Clinical Research Data Management System manages clinical trial data in support of medical research activity across the USAMRMC. The system supports the full life cycle of clinical studies from study inception through data field definition/specification, data entry, data query, data transfer/output into stand-alone statistical tools and study close-out.
- Electronic Common Technical Document assures FDA compliance in submitting standard eCTD format documentation, interfacing with the eIT PMO EDMS to pull documents and compile them into an FDA-acceptable format for all electronic submissions from the USAMRMC.
For additional information about the eIT PMO, please access the eIT PMO website or email the eIT PMO at USArmy.Detrick.MEDCOM-USAMRMC.Other.eIT-PMO@health.mil.