Governance Processes Functional 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.
From inherited abstract Artifact Functional Profile
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.
From inherited abstract Governance Functional Profile
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.
Governance is expressed through policies and assumes multiple use of focused policy modules that can be employed across many common circumstances.
SOA governance requires numerous architectural capabilities on the Semantic Infrastructure:
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.
From inherited abstract Management Functional 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.
Capability Elaborations
This Functional Profile includes, but is not limited to, the following capability elaborations:
- buildRepository
- caDSR-3
- discovery
- governanceService
- governanceWorkflow
- identity
- managementInformation
- managementNotification
- managementProcesses
- metadata
- registryManagement
- store
Derived From Requirements
- Gap Analysis::caDSR::caDSR-3 - Support multiple governance models 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::CDISC::CDISC-2 - Provide workflow support for governance processes 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::HL7 CIC::CIC-6 - Support needed governance procedures for managing the registry 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-8 - Support one or more procedures for building and maintaining a repository 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,
- Semantic Infrastructure Requirements::Service Discovery and Governance::Service Governance and workflows 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.
buildRepository capability elaboration
Support one or more procedures for building and maintaining a repository.
caDSR-3 capability elaboration
Support multiple governance models
discovery capability elaboration
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.
governanceService capability elaboration
SOA services to access automated implementations of the Governance Processes.
governanceWorkflow capability elaboration
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.
identity capability elaboration
Descriptions which include a unique identifier for the artifact.
managementInformation capability elaboration
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.
managementNotification capability elaboration
A mechanism to inform participants of significant management events, such as changes in rules or regulations.
managementProcesses capability elaboration
Accessible storage of the specifics of processes followed by management.
metadata capability elaboration
A representation of the meaning of terms used to describe the artifact, its functions, and its effects.
registryManagement capability elaboration
Support needed governance procedures for managing the registry.
store capability elaboration
Accessible storage of artifacts and artifact descriptions, so service participants can access, examine, and use the artifacts as defined.
