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.
This Functional Profile includes, but is not limited to, the following capability elaborations:
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.
caDSR-3
Support multiple governance models
governanceWorkflow
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.
registryManagement
Support needed governance procedures for managing the registry.
buildRepository
Support one or more procedures for building and maintaining a repository.
