Databases Reference
In-Depth Information
our working experiences, a suggested general requirement for metadata
repository will contain, but is not limited to:
• Metadata management (governance and process): It will build the
function to create new metadata, maintain existing metadata, and
archive and retire metadata. Metadata is needed to ensure consis-
tency in use and meaning of content within the business develop-
ment and across the clinical data life cycle, from trial design through
submission and beyond.
• Version control: The version control function should be built at the
level of terminology and element content. Version control of programs,
data, and output is needed to control process and provide transparency.
• Audit trail: It will consist of an audit function for traceability.
• Ability to create and use elements provisionally.
• Ability to choose when product standards or individual projects
inherit changes to industry/company/therapeutic standards.
• Ability for external users, such as CROs (clinical research organiza-
tions) and other partners, to request, create, and download a stan-
dard element electronically for use in their standard systems.
• Ability for configuration: It permits customization based on existing
business rules.
• Security: It can control access and permissions for objects and
actions. The security requirements are established by 21 CFR Part 11,
the regulation that directs organizations to have their electronic
processes under control. This is just a good business practice.
Another standard application approach is master data management
(MDM). Master data management is the practice of defining and main-
taining consistent definitions of business entities and reference data to
facilitate the accurate sharing of consistent data across multiple IT systems
and possibly beyond the enterprise to partnering business. Master data
objects are those core business objects that are used in different applica-
tions across the organization, along with their associated metadata, attri-
butes, definitions, roles, connections, and taxonomies. They are those
“things” on which successful business operations rely—what are logged
in our transaction systems, drive operations, are measured and reported
on in our reporting systems, and analyzed in our analytical systems.
MDM integrates policies and procedures for centralized information
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