1: Standards
Ensure the existence, harmonization, acceptance and support of standards for medical research Other Information:
As the science around discovery and development of therapies, medical research and personalized medicine progress, new measurements
of patient status and disease state will be introduced. These will range from biomarkers and laboratory values to measure
early activity of molecules to primary endpoints for clinical studies that are pivotal to approval. Recent examples include
imaging, pharmacogenomics, and patient reported outcomes. CDISC plays a role in determining the necessity for and timing of
standards creation around such parameters, influencing key stakeholders and other appropriate groups. CDISC will rely on the
CDISC Advisory Board (CAB), Board Strategy Committee and others to identify and raise awareness of new standards-related opportunities
and needs. Biomedical research standards development is the domain expertise of CDISC, whether CDISC acts as a doer, influencer,
facilitator or enabler. CDISC must track new developments and act nimbly to partner with important stakeholders to develop,
influence, approve, harmonize, and lifecycle manage new and existing standards. CDISC must input views into public debate
at the time of greatest potential impact. In addition to influencing decisions about emerging standards, CDISC must ensure
its standards are harmonized with one another and with other healthcare standards, specifically the HL7 Reference Information
Model (RIM). This can be accomplished by employing the domain analysis model, specifically the BRIDG (Biomedical Research
Integrated Domain Group) model. CDISC must maintain, support and enhance, as appropriate, the standards it develops; and,
CDISC must promote acceptance of its standards through various methods and implementation services. This strategic theme needs
to balance the old with the new. CDISC will support standards maintenance, but CDISC will not be expected to provide maintenance
a priori. This decision should be made each time new work is considered. The long-term benefit of any standards organization
is measured through widespread adoption of its standards. A significant challenge for potential adopters of CDISC data standards,
especially large organizations, is determining how best to implement those standards within the organization's overall plans
for business transformation and technology management. It is difficult for organizations to change their business practices,
and CDISC should support all degrees of conformance to standards. CDISC should support standard data content (semantic interoperability)
as expressed in BRIDG and the core concepts of existing standards, standard data transport (application and data interoperability)
through work with HL7 and support of CDISC define.xml. CDISC must explore standard architectures that support common user
interfaces and work processes (application integration). Distinguishing between data content, data transport, and data architecture
will allow businesses to use CDISC standards to the extent they support their business objectives. CDISC should make clear
these distinctions and support all degrees of business and technology standardization. CDISC has had tremendous success in
developing standards in several areas due in large part to the efforts of volunteer subject matter experts (SMEs). CDISC standards
are strong because of the relative simplicity of their structures and because of their intuitive design aimed at meeting the
users' needs. CDISC standards are continuously evolving within a stable process targeting compliance with existing and future
regulatory requirements. CDISC standards simplify data collection and end-to-end data handling processes. CDISC has also successfully
developed controlled terminology and best practices across its various models all of which can be viewed as a complete package
that addresses both format and content. Therefore, CDISC has a responsibility to ensure these standards, related terminology
and best practices are properly maintained with continued support from the industry SMEs who have helped bring about success.
Objective(s):
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