The Enterprise Information Technology Project Management Office (eIT PMO) provides and sustains a suite of USAMRMC Medical
Research Enterprise IM/IT solutions that meet the needs of the Command and its collaborators. The mission of the eIT PMO
- Facilitate full program coordination, planning, management, and execution to ensure successful acquisition of required
medical research IT solutions.
- Procure, configure, and sustain IT solutions for USAMRMC's medical research activities in accordance with Department of
Defense, US Food and Drug Administration (FDA), and Army Medical Command policies and regulations.
- Coordinate with USAMRMC Medical Research Functional Sponsors in the prioritization and successful implementation of IT
solutions throughout USAMRMC.
The eIT PMO products are compliant with the overarching requirements found in the FDA Title 21 of the Code of Federal
Regulations (CFR), Part 11, for Electronic Records; Electronic Signatures. Without these capabilities, USAMRMC cannot perform
core mission activities with the FDA.
The eIT PMO product suite provides the following capabilities:
- Electronic Document Management System (EDMS) provides electronic document management and electronic signature capability
for FDA regulated and Research Management Enterprise (RME) non-regulated activities across USAMRMC.
- Serious Adverse Event (SAE) provides electronic storage and automation for serious adverse event management/reporting.
- Electronic Data Capture - Clinical Research Data Management System (EDC-CRDMS) provides the capability to electronically
manage clinical trial data in support of medical research activity across 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.
- Clinical Trial Management System (CTMS) provides an end to end clinical trial management solution that includes tools
to plan, start up, conduct, and manage studies while supporting monitoring and regulatory compliance activities. CTMS
supports every study aspect including design, procedures, protocol, study arms, visits, forms, treatments, budgets,
payments, and more.
- Electronic Common Technical Document (eCTD) meets the FDA requirement to submit documentation in standard eCTD format and
interfaces with the eIT PMO EDMS to pull documents and compile them into the acceptable format for USAMRMC electronic
submissions to the FDA.
If you would like additional information about the eIT PMO, please access the
eIT PMO Website
or email the eIT PMO mailbox
Forms and instructions for obtaining a user account for any of the eIT PMO products are located
on the Account Request page of the eIT PMO website