1.1.3 - Manage

Create caBIG identifiers to facilitate the traceability of clinical data to biospecimen to molecular data

Gap Analysis::Manage::014 - Data traceability

dataTraceability

Track who else has used a set or a particular data element and how often it’s been used

Gap Analysis::Manage::018.2 - Track Data Element Usage

trackDataElementUsage

Add rich metadata (provenance, lifecycle, use, etc.) to all types of entities, including services, end-points, complex data types, workflows, events to support semantic interoperability

Gap Analysis::Manage::059 - Rich Metadata

richMetadata

Allow users to create and share private collections of entities and define how they are shared

Gap Analysis::Manage::086 - Create and share private entities

entitySharing

Need to have private and public content in the MDR;

Gap Analysis::Manage::098.2 - Private Content

privateContent

Manage lifecycle of terminology artifacts

Gap Analysis::Manage::128 - Manage lifecycle of terminology artifacts

manageTerminologyArtifactLifecycle

Artifact lifecycle management and metadata requirements include the ability to: * Manage lifecycle, governance and versioning of the models, content and forms * Establish relationships and dependencies between models, content and forms * Determine provenance, jurisdiction, authority and intellectual property * Create represention and views of the information, realized through the appropriate transforms * Provide access control and other security constraints * Create annotations for better discovery and searching of artifacts * Develop usage scenarios and context for the information * Provide terminology and value set binding The artifacts are bound to the services via the service metadata. The service metadata combined with the artifacts and supporting metadata provide a comprehensive service specification. The artifact management requirements listed above are derived from the following use cases: * caEHR: The caEHR project has adopted ECCF for specifications and CDA documents for interoperability. The caEHR project requirements include the need for an infrastructure for managing all the artifacts generated during specification process, including HL7 models and documents. The caEHR project also intends to publish these artifacts for the community and vendors. The infrastructure needs to support better discovery, making all the relevant information available in the right context. * ONC and other external EHR adopters: ONC has adopted CCD and CCR for meaningful use. All national EHR implementations are expected to support forms and the semantics of these forms play a critical role in interoperability. The semantic infrastructure must provide a mechanism to create, store and manage these forms. * Clinical Trials: Clinical trials use forms to capture clinical information, and the semantics captured by these forms are critical for interoperability and reporting. The semantic infrastructure must provide a mechanism to manage the lifecycle of these forms.

Semantic Infrastructure Requirements::Artifact Management::Artifact Lifecycle Management

dataTraceability


trackDataElementUsage


richMetadata


entitySharing


privateContent


manageTerminologyArtifactLifecycle


provenanceAndLifecycleMetadata

In order to allow data sets to be shared, compared and repurposed across clinical trials, research databases, and organizations the caDSR needs to be able to attach and publish provenance and lifecycle metadata about those data sets. This requirement indicates many things, among them: * a need to minimize barriers to accessing metadata * a need to describe the workflow, provenance, and governance information associated with metadata

Gap Analysis::caDSR::caDSR-2 - Capture and publish provenance and lifecycle metadata

provenanceAndLifecycleMetadata

In conjunction with CDISC-1 distributed Knowledge Repository a tool will be needed to create/add, delete, update/modify and retire content from multiple sources.  There must be version control for CDISC objects (e.g., attributes, associations, classes, etc.).  This includes versioning information about CDISC controlled terminology and any external authoritative source terminologies.  The KR and Tools should provide a mechanism for preserving and viewing the contributing sources and/or contributing organizations for each object.  Detailed tracking of contributions among objects is not required. Source: * CDISC Share Pilot Report * CDISC Requirements Package 1 - NCI Semantic Infrastructure, 5/28/2010, Section 2.5 & Section 2.8

Gap Analysis::CDISC::CDISC-16 - Ensure versioning, change management and traceability

provenanceAndLifecycleMetadata


manageTerminologyArtifactLifecycle


dataTraceability

There is a need to have the registry support keeping track of data provenance 

Gap Analysis::HL7 CIC::CIC-13 -  Track data provenance and recover from errors

trackDataProvenance

KR needs a governance workflow process built into the UI that conforms to the requirements of NCI provenance

Gap Analysis::EVS::EVS-4 - Governance WorkFlow Conforming to NCI Provenance

nciProvenanceModel

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

discovery from inherited abstract profile Artifactidentity from inherited abstract profile Artifactmetadata from inherited abstract profile Artifactstore from inherited abstract profile Artifact

Provenance encompasses the origin and traceability of data throughout an ecosystem. This is a clear requirement directly from the use case in order to ensure that all steps of patient care and research are clearly linked via the patient record. The semantic infrastructure will provide data provenance support. Link to use case satisfied from caGRID 2.0 Roadmap: The origin of data is tied to the data creator, allowing the oncologist performing the match against TCGA data and other datasets to include and exclude data sets based on their origin.

Semantic Infrastructure Requirements::caGRID 2.0 Platform and Terminology Integration::Provenance

nciProvenanceModel


nciProvenanceModel

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 Artifact

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