Welcome to Enterprise Information Technology PMO
Welcome to the United States Army Medical Research and Materiel Command (USAMRMC), Enterprise Information Technology Project Management Office (eIT PMO) web site. This web site provides our customers, collaborators, and stakeholders with updated information on the portfolio of products and activities that this office supports.
Currently, the eIT PMO portfolio includes four FDA compliant capabilities; the Electronic Document Management System (EDMS), the Serious Adverse Event (SAE) reporting system, the Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS), and the Electronic Common Technical Document (eCTD) system. A Clinical Trial Management System (CTMS) has been procured, with production implementation targeted for the 4th QTR FY16.
- EDMS is certified as an enterprise content management system, used for collaboration internal and external to the Command, to track and store documents and scanned images of paper copies, is optical character recognition (OCR) capable, and provides version control, robust audit trails, and automated business process tools.
- SAE is used to capture and report on serious adverse events that occur during clinical trials and also provides an audit trail.
- EDC-CRDMS is a centralized data capture system supporting the life cycle of clinical trial 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.
- eCTD enables the Command to create electronic regulatory submissions and transfer the information to the FDA in the required electronic submission format.
- CTMS will be 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 to include: design, procedures, protocol, study arms, visits, forms, treatments, budgets, payments, and more.
EDMS, SAE, EDC-CRDMS, eCTD, and CTMS are commercial-off-the-shelf (COTS) products configured to satisfy USAMRMC functional requirements.
The eIT PMO publishes a quarterly newsletter. Check them out here.
Please contact us if you have any questions regarding the products that we support. We welcome any suggestions or comments to make this web site more informative.
Last Modified Date: 07-November-2016