Summary
Description of the profile
The BIG Health vision brings a lot more stakeholders into the KR. Each of these has their own governance processes in respect to metadata and terminology. At a minimum the KR has to be aware of these processes, and their outcomes, to be able to express the status of metadata definitions and terminology concepts it contains. Some stakeholders expressed the wish to manage their governance processes within the KR.
An artifact is a managed resource within the Semantic Infrastructure.
An artifact is associated with the following capabilities:
- descriptions to enable the artifact to be visible, where the description includes a unique identifier for the artifact and a sufficient, and preferably a machine processible, representation of the meaning of terms used to describe the artifact, its functions, and its effects;
- one or more discovery mechanisms that enable searching for artifacts that best meet the search criteria specified by the service participant; where the discovery mechanism will have access to the individual artifact descriptions, possibly through some repository mechanism;
- accessible storage of artifacts and artifact descriptions, so service participants can access, examine, and use the artifacts as defined.
Service Oriented Architecture is an architectural paradigm for organizing and utilizing distributed capabilities that may be under the control of different ownership domains. Consequently, it is important that organizations that plan to engage in service interactions adopt governance policies and procedures sufficient to ensure that there is standardization across both internal and external organizational boundaries to promote the effective creation and use of SOA-based services.
SOA governance requires numerous architectural capabilities on the Semantic Infrastructure:
Governance is expressed through policies and assumes multiple use of focused policy modules that can be employed across many common circumstances This is elaborated in the inherited Policy profile.
Governance requires that the participants understand the intent of governance, the structures created to define and implement governance, and the processes to be followed to make governance operational. This is provided by capabilities specialized from the inherited Management Profile.
Governance policies are made operational through rules and regulations. This is provided by the following capabilities, most of which are specializations of the inherited Artifact Profile:
- descriptions to enable the rules and regulations to be visible, where the description includes a unique identifier and a sufficient, and preferably a machine process-able, representation of the meaning of terms used to describe the rules and regulations;
- one or more discovery mechanisms that enable searching for rules and regulations that may apply to situations corresponding to the search criteria specified by the service participant; where the discovery mechanism will have access to the individual descriptions of rules and regulations, possibly through some repository mechanism;
- accessible storage of rules and regulations and their respective descriptions, so service participants can understand and prepare for compliance, as defined.
- SOA services to access automated implementations of the Governance Processes.
Governance implies management to define and enforce rules and regulations.. This is elaborated in the inherited Management profile.
Governance relies on metrics to define and measure compliance. This is elaborated in the inherited Metric profile.
Governance implies management to define and enforce rules and regulations.
Management is provided by the following capabilities:
- an information collection site, such as a Web page or portal, where management information is stored and from which the information is always available for access;
- a mechanism to inform participants of significant management events, such as changes in rules or regulations;
- accessible storage of the specifics of processes followed by management.
Artifact Descriptions include references to metrics which describe the operational characteristics of the subjects being described
Architectural implications of metrics on the Semantic Infrastructure are reflected in the following capabilities:
- access to platform infrastructure monitoring and reporting capabilities
- access to metrics information generated or accessible by related services
- mechanisms to catalog and enable discovery of which metrics are available for a described artifact and information on how these metrics can be accessed;
- mechanisms to catalog and enable discovery of compliance records associated with policies, contracts, and constraints that are based on these metrics.
Capabilities
- buildRepository
- caDSR-3
- complianceDiscovery
- discovery
- governanceService
- governanceWorkflow
- identity
- managementInformation
- managementNotification
- managementProcesses
- metadata
- metrics
- metricsDiscovery
- monitor
- provenance
- registryManagement
- store
Requirements traceability
Requirement |
Source |
Capability |
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There are questions as to whether a local data element definition is the same or different from existing caDSR data element definitions. The quality of definitions can vary and they are updated over time. In addition, with caDSR the associated organizations each have a rich committee structure to review and curate data element definitions. For example, CTEP (Cancer Therapy Evaluation Program) has a series of disease related committees that help submit, review, and approve clinical trial schema and has its own associated governance processes. This means that community and common data elements should include associated subject matter expert or external standard provenance data as well as a defined governance process. This should also includes who submitted the original community definitions, and who was involved in authoring the definitions at each of the normalization and harmonization workflow steps. The workflows can vary based on the organizations involved. Sources * Essentials of caBIG® Compatibility: From Theory to Practice – Metadata Reuse (2009 Presentation) * Interview 5/24/2010 Dianne Reeves |
Gap Analysis::caDSR::caDSR-3 - Support multiple governance models |
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The CDISC SHARE (Shared Health and Research Electronic Library) Pilot report often found that the initial data element definitions were not of high quality and it was sometimes hard to find the original authors. This means that community and common data elements should have associated subject matter expert or external standard provenance data. This includes who submitted the original community definitions, and who was involved in authoring the definitions at each of the normalization and harmonization workflow steps, including their final release in a new or updated CDISC standard. The current prototype workflow steps consist of: (a) Contribute & Link, (b) Merge (HL7 Normalization), (c) Harmonize (HL7 Normalization & Harmonization) (d) New Definition (HL7 Normalization). These workflow steps are outlined in the CDISC SHARE Pilot Report. The KR should include a well-documented and automated (as much as possible) workflow mechanism to ensure that CDISC SHARE change/update and addition requests are handled efficiently and promptly. As noted in CDISC-6, CDISC also wants the ability to construct and then re-define the harmonization workflow process. CDISC states that governance in general and this kind of workflow control is central to the creation of successful CDISC standards. *Source: * * Interview 5/20/2010 , David Iberson-Hurst & Ronda Facile * CDISC Share Pilot Report and CDISC Requirements Package 1 - NCI Semantic Infrastructure, 5/28/2010, Section 2.5 |
Gap Analysis::CDISC::CDISC-2 - Provide workflow support for governance processes |
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There is a need to permit registration of a data element which requires a set of governance procedures for managing the registry as follows: * Track and report on subject matter responsibility/ownership, for submitted data elements. * Monitor adherence to rules for providing metadata for each attribute * Monitor adherence to conventions for forming definitions, creating names, and performing classifications * Archive an administered item which no longer has relevance * Determine the similarity of related administered items and harmonizing their differences * Determine whether it is possible and necessary to ever get higher quality metadata for some administered items * User being able to map their process to a specific control terminology |
Gap Analysis::HL7 CIC::CIC-6 - Support needed governance procedures for managing the registry |
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There is a need to use a set of process guidelines such as those defined in the HL7 HDF to guide the satisfaction of these needs, |
Gap Analysis::HL7 CIC::CIC-8 - Support one or more procedures for building and maintaining a repository |
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Semantic Profile::OASIS SOA::Governance Model |
monitor from inherited abstract profile Metrics, metrics from inherited abstract profile Metrics, managementInformation from inherited abstract profile Management, managementNotification from inherited abstract profile Management, managementProcesses from inherited abstract profile Management, governanceService from inherited abstract profile Governance, discovery from inherited abstract profile Artifact, identity from inherited abstract profile Artifact, metadata from inherited abstract profile Artifact, store from inherited abstract profile Artifact, |
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Semantic Profile::OASIS SOA::Service Description Model |
discovery from inherited abstract profile Artifact, identity from inherited abstract profile Artifact, metadata from inherited abstract profile Artifact, store from inherited abstract profile Artifact, monitor from inherited abstract profile Metrics, metrics from inherited abstract profile Metrics, metricsDiscovery from inherited abstract profile Metrics, complianceDiscovery from inherited abstract profile Metrics, |
This includes predefined templates, workflows, and governance policies for governing the service lifecycle as well as an approval and review process for service specifications and the ability to promote services through the stages of the service lifecycle. |
Semantic Infrastructure Requirements::Service Discovery and Governance::Service Governance and workflows |
buildRepository
Description
Support one or more procedures for building and maintaining a repository.
Requirements addressed
Overview of possible operations
caDSR-3
Description
Support multiple governance models
Requirements addressed
Overview of possible operations
complianceDiscovery
Description
Mechanisms to catalog and enable discovery of compliance records associated with policies, contracts, and constraints that are based on these metrics.
Requirements addressed
Overview of possible operations
discovery
Description
One or more discovery mechanisms that enable searching for artifacts that best meet the search criteria specified by the service participant; where the discovery mechanism will have access to the individual artifact descriptions, possibly through some repository mechanism.
Requirements addressed
Overview of possible operations
governanceService
Description
SOA services to access automated implementations of the Governance Processes.
Requirements addressed
Overview of possible operations
governanceWorkflow
Description
Provide workflow support for governance processes
This includes predefined templates, workflows, and governance policies for governing the service lifecycle as well as an approval and review process for service specifications and the ability to promote services through the stages of the service lifecycle.
Requirements addressed
Overview of possible operations
identity
Description
Descriptions which include a unique identifier for the artifact.
Requirements addressed
Overview of possible operations
managementInformation
Description
An information collection site, such as a Web page or portal, where management information is stored and from which the information is always available for access.
Requirements addressed
Overview of possible operations
managementNotification
Description
A mechanism to inform participants of significant management events, such as changes in rules or regulations.
Requirements addressed
Overview of possible operations
managementProcesses
Description
Accessible storage of the specifics of processes followed by management.
Requirements addressed
Overview of possible operations
metadata
Description
A representation of the meaning of terms used to describe the artifact, its functions, and its effects.
Requirements addressed
Overview of possible operations
metrics
Description
Access to metrics information generated or accessible by related services
Requirements addressed
Overview of possible operations
metricsDiscovery
Description
Mechanisms to catalog and enable discovery of which metrics are available for a described artifact and information on how these metrics can be accessed.
Requirements addressed
Overview of possible operations
monitor
Description
Access to platform infrastructure monitoring and reporting capabilities.
Requirements addressed
Overview of possible operations
provenance
Description
While the Resource identity provides the means to know which subject and subject description are being considered, Provenance as related to the Description class provides information that reflects on the quality or usability of the subject. Provenance specifically identifies the entity (human, defined role, organization, ...) that assumes responsibility for the resource being described and tracks historic information that establishes a context for understanding what the resource provides and how it has changed over time. Responsibilities may be directly assumed by the Stakeholder who owns a Resource or the Owner may designate Responsible Parties for the various aspects of maintaining the resource and provisioning it for use by others. There may be more than one entity identified under Responsible Parties; for example, one entity may be responsible for code maintenance while another is responsible for provisioning of the executable code. The historical aspects may also have multiple entries, such as when and how data was collected and when and how it was subsequently processed, and as with other elements of description, may provide links to other assets maintained by the Resource owner.
Requirements addressed
Overview of possible operations
registryManagement
Description
Support needed governance procedures for managing the registry.
Requirements addressed
Overview of possible operations
store
Description
Accessible storage of artifacts and artifact descriptions, so service participants can access, examine, and use the artifacts as defined.
