Frequently Asked Questions
Table of Contents
- Who is the eIT PMO?
- Who uses these systems?
- Why does DHA 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) consists of people, processes, and technology that work to procure, configure, and sustain medical research IT solutions to meet the needs of the DHA and its collaborative partners. The eIT PMO was officially chartered by the Principal Assistant for Acquisition on 18 September 2008. In 2024, eIT PMO transitions to DHA and the Project Manager reports to the DHA Assistance Director Support (AD-S).
Our team supports DHA customers along with external partners in industry and academia and across the agencies. We assist our customers in identifying and developing their initial problem statement and determine possible solutions existing within eIT PMO capabilities. We coordinate the requirements and planning process, as well as the acquisition process if needed, following DoD 5000.75 Business System Acquisition procedures, to resolve customer needs with an IM/IT solution. The eIT PMO also manages the business and cyber compliance requirements while sustaining application upgrades following the DOD, DHA and FDA regulations.
The seven major eIT PMO functional capabilities include: the Electronic Document Management System (EDMS), the Serious Adverse Event (SAE) reporting system, the Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS), the electronic Common Technical Document (eCTD) system, the FDA Study Data Validator (SDV) and Biodefense Laboratory Management System (BLMS). These enterprise-wide IT solutions support FDA regulated and non-regulated medical research activities.
Who uses these systems?
The eIT PMO portfolio of products are used by DHA personnel and their collaborators in industry, academia, other government agencies, and our foreign allies. A full list of organizations we support is available on our Supported Organizations page.
Why does DHA 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 DHA 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 DHA 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. DHA 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 DHA by providing data integrity, security, access, and speed.
How do I reset my password or reactivate my account on an eIT PMO system?
To reset your password or reactivate your user account on any eIT PMO product, please contact us.
How do I request a system account?
See the Account Request page for instructions and forms to request a user account for any of the eIT PMO products.