Frequently Asked Questions

Table of Contents

• Who is the eIT PMO?
• Who uses these systems?
• Why does USAMRMC need these systems?
• How do I reset my password or reactivate my account on one of your systems?
• How do I request an account?

Who is the eIT PMO?

The Enterprise Information Technology (eIT) Project Management Office (PMO) was officially chartered by the Principal Assistant for Acquisition on 18 September 2008. The eIT PMO Project Manager reports to the USAMRMC Commanding General (CG), through the Principal Assistant for Acquisition. The eIT PMO facilitates full program coordination, planning, management and execution to ensure successful acquisition of required medical research IT solutions.

The eIT PMO consists of people, processes, and technology that work to procure, configure, and sustain medical research IT solutions to meet the needs of the USAMRMC and its collaborative partners.

The eIT PMO portfolio of enterprise IT products support FDA regulated and non-regulated medical research activities. The four major eIT PMO components in Production include: the Electronic Document Management System (EDMS), the Serious Adverse Events (SAE) reporting system, the Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS), and the electronic Common Technical Document (eCTD) system. These enterprise-wide IT solutions for USAMRMC will provide regulatory compliant systems that:

• Electronically capture data from clinical trials,
• Support the FDA’s safety reporting requirements for all approved drug and therapeutic biologics by reporting serious adverse reactions occurring during clinical trials,
• Support the process of compiling high quality electronic submissions to the FDA, via the FDA gateway portal, in accordance with FDA requirements,
• Provide an enterprise content management solution for medical research collaboration to improve data consistency flow between DoD organizations, academia, external industry partners, and the FDA.

Who uses these systems?

The eIT PMO portfolio of products are currently being used by USAMRMC personnel and their collaborators in industry, academia, other government agencies, and our foreign allies. Locations include USAMRMC HQ, WRAIR, USAMMDA, USAMRICD, AFRIMS, USACEHR, USAMMA, USAMRIID, USAMRAA, USARMU-K, USAISR, USARIEM, USAARL, USAMRU-G, MMESO, JOINT SERVICES, NMRC, DCDD, WRNMMC, CBMS, VA, and NSRDEC.

Why does USAMRMC need these systems?

In the past, research information was captured in unconnected, home-grown databases and large, paper-based files. There was no system that tracked where all of this data was stored, and it was not readily accessible to make informed decisions. There are specific regulations and requirements that USAMRMC IT systems must meet in the management of information that will be submitted to the Food and Drug Administration (FDA). One of these requirements, the Title 21 Code of Federal Regulations (CFR), Part 11 , can be thought of as an "umbrella" that covers the computer systems, data, and signature requirements of Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs) when the data and signatures are in electronic format. The GLP, GCP, Good Manufacturing Practice (GMP), and other FDA regulations that provide the systems, records, and signature requirements are called "Predicate Rules”.

Overall, the FDA expects USAMRMC to provide trustworthy data; accurate and complete records and reports; reliable systems and processes; secure data; systems and facilities; as well as qualified and trained personnel when using computerized records. This compliance is required when FDA-regulated records are created, modified, maintained, archived, retrieved, or transmitted in electronic form, or are electronically signed or submitted to the FDA. USAMRMC also needs these systems to attract and work with Cooperative Research and Development Agreements (CRADA) partners, who use the industry's best practices, which will improve the quality and credibility of our scientific data. Overall, these systems will improve business processes across USAMRMC by providing data integrity, security, access, and speed.

How do I reset my password or reactivate my account on a eIT PMO system?

To have your password reset or reactivate your account on any eIT PMO product, contact the eIT PMO Mailbox (usarmy.detrick.medcom-usamrmc.other.eit-pmo@mail.mil) during EST business hours or the USAMITC ESD by email or telephone 1-800-872-6482. ESD is available 24x7.

How do I request a system account?

See the Account Request page for instructions and forms to request an account for one of the eIT PMO products.