Resources

Statutory Requirements & Guidance Documents

• The National Defense Authorization Act is a legislative act passed by Congress each year, which provides authorization of appropriations for the Department of Defense. The NDAA establishes defense policies and restrictions to improve DOD oversight in capital planning, investment control, and reduce duplication of services.
• Public Law 115-92 is a statutory requirement that mandates and enables the DOD and the Food and Drug Administration to collaborate and expedite the development of medical products to protect military personnel. This law provides specific authorities and requirements, such as the ability for the DOD to request expedited review and the obligation for both agencies to meet regularly, creating a statutory framework for enhanced engagement and faster access to crucial medical countermeasures
• Title 10 of the Clinger-Cohen Act (Subtitle III, Title 40) of United States Code § 2222 sets forth statutory requirements for managing and overseeing DBSs, including the annual certification requirement.
• DoD Instruction 5000.75 establishes the Business Capability Acquisition Cycle framework for acquiring and managing business systems. The MeRITS enclave is designated as Phase 5 of BCAC framework, which is explicitly defined as "Capability Support."
• FDA 21 CFR Part 11 Compliant (Electronic Records; Electronic Signatures) for computerized systems. eIT PMO centrally manages for all users (regulated and nonregulated) per our proven enterprise system lifecycle methodology.

System Compliance Statements

MeRITS: Medical Research Information Technology System

• Regulatory Compliance Requirement: U.S. Code Title 10, U.S. Code, Section 2222 Public Law 115-92
• Use Area: Required to be compliant with Clinger Cohen Act: Defense business systems: business process reengineering; enterprise architecture. Required enhanced collaborations and communication between the U.S. DOD and the U.S. FDA on DOD's medical product priorities for military emergencies.

EDMS: Electronic Document Management System

• Regulatory Compliance Requirement: ICH E6 GCP, Title 21 CFR Part 11
• Use Area: Required for quality system (regulatory training records, SOP management, Sponsor’s regulatory files archives)

eCTD: electronic Common Technical Document Publisher/Viewer

• Regulatory Compliance Requirement: Section 745A(a) of the FD&C Act and FDA/ICH guidance documents, CDER, CBER, ICH M8, Title 21 CFR Part 11
• Use Area: Required for FDA submission publishing

EDC: Electronic Data Capture

• Regulatory Compliance Requirement: ICH E6, CDISC, CDASH, Title 21 CFR Part 11
• Use Area: Required for clinical trial data capture and management

FDA SDV: Study Data Validator

• Regulatory Compliance Requirement: Section 745A(a) of the FD&C Act and FDA guidance documents, Title 21 CFR Part 11
• Use Area: Required for study data validation prior to FDA submission

LIMS: Laboratory Information Management System/Product Accountability System

• Regulatory Compliance Requirement: Title 21 CFR part 312, Title 21 CFR Part 11
• Use Area: LIMS required for investigational product stability and accountability

SAE: Serious Adverse Event

• Regulatory Compliance Requirement:  Title 21 CFR part 312, ICH E2A-E2F, Title 21 CFR Part 11
• Use Area: Required for mandatory reporting of clinical research safety events

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