5.2.1.1.3 - Manage Sept. 6, 2010

Manage Functional Profile

Determine provenance, jurisdiction, authority and intellectual property.

Provide access control and other security constraints.

This category is an aggregation of all the service profiles within the Administer / Manage group, and the Annotate profile.

Manage lifecycle, governance and versioning of the models, content and forms.

The KR should keep track of each version, any relevant provenance information (e.g., who made the change), and supports the concept of being able to revert to any prior state. This version control would include the authoring of any new metadata (making contexts more explicit) and the assertions of model alignments.

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.

Links services to all the supporting artifacts in the specification

This Functional Profile includes, but is not limited to, the following capability elaborations:

Derived From Requirements

Gap Analysis::Manage::014 - Data traceability Create caBIG identifiers to facilitate the traceability of clinical data to biospecimen to molecular data
Gap Analysis::Manage::018.2 - Track Data Element Usage Track who else has used a set or a particular data element and how often it’s been used
Gap Analysis::Manage::059 - Rich Metadata 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::086 - Create and share private entities Allow users to create and share private collections of entities and define how they are shared
Gap Analysis::Manage::098.2 - Private Content Need to have private and public content in the MDR;
Gap Analysis::Manage::128 - Manage lifecycle of terminology artifacts Manage lifecycle of terminology artifacts
Semantic Infrastructure Requirements::Artifact Management::Artifact Lifecycle Management 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.
Gap Analysis::caDSR::caDSR-2 - Capture and publish provenance and lifecycle metadata 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::CDISC::CDISC-16 - Ensure versioning, change management and traceability 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::HL7 CIC::CIC-13 - Track data provenance and recover from errors There is a need to have the registry support keeping track of data provenance
Gap Analysis::EVS::EVS-4 - Governance WorkFlow Conforming to NCI Provenance KR needs a governance workflow process built into the UI that conforms to the requirements of NCI provenance
Semantic Infrastructure Requirements::caGRID 2.0 Platform and Terminology Integration::Provenance 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.

richMetadata

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

entitySharing

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

privateContent

Need to have private and public content in the MDR;

manageTerminologyArtifactLifecycle

Manage lifecycle of terminology artifacts

trackDataProvenance

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

dataTraceability

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

nciProvenanceModel

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

provenanceAndLifecycleMetadata

Capture and publish provenance and lifecycle metadata

trackDataElementUsage

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

Content

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