5.4.1 - Governance Processes

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

caDSR-3

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

governanceWorkflow

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

registryManagement

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

buildRepository

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.

Semantic Profile::OASIS SOA::Governance Model

monitor from inherited abstract profile Metricsmetrics from inherited abstract profile MetricsmanagementInformation from inherited abstract profile ManagementmanagementNotification from inherited abstract profile ManagementmanagementProcesses from inherited abstract profile ManagementgovernanceService from inherited abstract profile Governancediscovery from inherited abstract profile Artifactidentity from inherited abstract profile Artifactmetadata from inherited abstract profile Artifactstore from inherited abstract profile Artifact

A service description is an artifact, usually document-based, that defines or references the information needed to use, deploy, manage and otherwise control a service. This includes not only the information and behavior models associated with a service to define the service interface but also includes information needed to decide whether the service is appropriate for the current needs of the service consumer. Thus, the service description will also include information such as service reachability, service functionality, and the policies and contracts associated with a service. A service description artifact may be a single document or it may be an interlinked set of documents. Architectural implications of service description on the Semantic Infrastructure are reflected in the following functional decomposition: * Description will change over time and its contents will reflect changing needs and context. This is elaborated in the inherited Change profile. * Description makes use of defined semantics, where the semantics may be used for categorization or providing other property and value information for description classes. This is elaborated in the inherited Semantic Model profile. * Descriptions include reference to policies defining conditions of use and optionally contracts representing agreement on policies and other conditions. This is elaborated in the inherited Policy profile. * Descriptions include references to metrics which describe the operational characteristics of the subjects being described. This is elaborated in the inherited Metrics profile. * Descriptions of the interactions are important for enabling auditability and repeatability, thereby establishing a context for results and support for understanding observed change in performance or results. This is elaborated in the inherited Interaction profile. * Descriptions may capture very focused information subsets or can be an aggregate of numerous component descriptions. Service description is an example of a likely aggregate for which manual maintenance of all aspects would not be feasible. This is elaborated in the inherited Composition profile. * Descriptions provide up-to-date information on what a resource is, the conditions for interacting with the resource, and the results of such interactions. As such, the description is the source of vital information in establishing willingness to interact with a resource, reachability to make interaction possible, and compliance with relevant conditions of use. This is elaborated in the inherited Interoperability profile. Policy capabilities are specialization of Artifact capabilities.

Semantic Profile::OASIS SOA::Service Description Model

discovery from inherited abstract profile Artifactidentity from inherited abstract profile Artifactmetadata from inherited abstract profile Artifactstore from inherited abstract profile Artifactmonitor from inherited abstract profile Metricsmetrics from inherited abstract profile MetricsmetricsDiscovery from inherited abstract profile MetricscomplianceDiscovery 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

governanceWorkflow

One of the key requirements for participants interacting with each other in the context of a SOA is achieving visibility: before services can interoperate, the participants have to be visible to each other using whatever means are appropriate. The Reference Model analyzes visibility in terms of awareness, willingness, and reachability. Visibility in a SOA ecosystem has the following architectural implications on mechanisms providing support for awareness, willingness, and reachability: Mechanisms providing support for awareness will likely have the following minimum capabilities: * creation of Description, preferably conforming to a standard Description format and structure; * publishing of Description directly to a consumer or through a third party mediator; * discovery of Description, preferably conforming to a standard for Description discovery; * notification of Description updates or notification of the addition of new and relevant Descriptions; * classification of Description elements according to standardized classification schemes. In a SOA ecosystem with complex social structures, awareness may be provided for specific communities of interest. The architectural mechanisms for providing awareness to communities of interest will require support for: * policies that allow dynamic formation of communities of interest; * trust that awareness can be provided for and only for specific communities of interest, the bases of which is typically built on keying and encryption technology. The architectural mechanisms for determining willingness to interact will require support for: * verification of identity and credentials of the provider and/or consumer; * access to and understanding of description; * inspection of functionality and capabilities; * inspection of policies and/or contracts. The architectural mechanisms for establishing reachability will require support for: * the location or address of an endpoint; * verification and use of a service interface by means of a communication protocol; * determination of presence with an endpoint which may only be determined at the point interaction but may be further aided by the use of a presence protocol for which the endpoints actively participate.

Semantic Profile::OASIS SOA::Service Visibility Model

discovery from inherited abstract profile Artifact