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Introduction
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Background/Scope
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Scope
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Users and Characteristics
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Related Documentation
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- Con Ops Supplemental Page for Requirements Gathering: Supplemental VCDE Requirements Elicitation Initiative 2009 - 2010;
- Semantic Requirements Forum: https://wikicabig-kc.nci.nih.gov/displayVocab/VCDE/Supplemental+Page+for+Requirements+Gathering Semantic Requirements Forum: https://cabig-kc.nci.nih.gov/Vocab/forums/viewforum.php?forums/viewforum.php?f=34
- Con Ops Stakeholders: Semantic Infrastructure Concept of Operations Stakeholders: https://cabig-kc.nci.nih.gov/Vocab/KC/index.php/SI_Conop_Stakeholders
- Con Ops Requirements: https://wiki.nci.nih.gov/display/VCDE/Requirements+Questionnaires
- Con Ops Use Cases: https://wiki.nci.nih.gov/display/VCDE/Use+Cases+for+Semantic+Requirements
Terms & Definitions
Term | Definition |
|---|---|
MUST | This word means that the definition is an absolute requirement of the specification. |
MUST NOT | This phrase means that the definition is an absolute prohibition of the specification. |
WILL | This word means that the definition is an absolute future requirement of the specification. |
WILL NOT | This phrase mean that the definition is an absolute future prohibition of the specification. |
SHOULD | This word means that there may exist valid reasons in particular circumstances to ignore a particular item, but the full implications must be understood and carefully weighed before choosing a different course. |
SHOULD NOT | This phrase means that there may exist valid reasons in particular circumstances when the particular behavior is acceptable or even useful, but the full implications should be understood and the case carefully weighed before implementing any behavior described with this label. |
MAY | This word means that a requirement is truly optional. The developer may choose to include the item based on the needs of their design. |
Assumptions and Dependencies
Usability
The user interface shall be designed for ease-of-use by the designated end-users, shall use terms common to the user's normal business environment, and shall require little to no additional training on the system. Drop down menus, Google-like searches, and tooltips should be used wherever appropriate.
Accessibility
The user interface should be accessible via a web browser.
General Assumptions
Following is a list of basic assumptions:
- Federated Discovery Services: Knowledge Repository Services will be distributable and discoverable in a federated manner
- Security Considerations: services and underlying data will be secured using the caBIG security architecture
- Subscriptions/Notifications: services requiring subscription and notification functionality will be enabled by the caBIG pub/sub architecture
- ISO 11179 Ed 3: the Knowledge Repository will comply with ISO 11179 Ed 3 specifications. See here for our analysis.
- Ability to have non-administered items: the Knowledge Repository will provide for non-administered items in the ISO 11179 notion
- Duplication/identification: in compliance with the Federated Discovery Services assumption, reference of data, data duplication, and unique identification of data will be handled
Dependencies
TBD
Functional Requirements
Model Services
Some basic description of model services.
- Con Ops Requirements: Requirements Questionnaires
- Con Ops Use Cases: Use Cases for Semantic Requirements
Terms & Definitions
Term | Definition |
|---|---|
MUST | This word means that the definition is an absolute requirement of the specification. |
MUST NOT | This phrase means that the definition is an absolute prohibition of the specification. |
WILL | This word means that the definition is an absolute future requirement of the specification. |
WILL NOT | This phrase mean that the definition is an absolute future prohibition of the specification. |
SHOULD | This word means that there may exist valid reasons in particular circumstances to ignore a particular item, but the full implications must be understood and carefully weighed before choosing a different course. |
SHOULD NOT | This phrase means that there may exist valid reasons in particular circumstances when the particular behavior is acceptable or even useful, but the full implications should be understood and the case carefully weighed before implementing any behavior described with this label. |
MAY | This word means that a requirement is truly optional. The developer may choose to include the item based on the needs of their design. |
Use Case Level Criteria
When designing use cases, it is important to maintain a consistent approach to determining at which level use cases are placed when they are authored. The granularity of the use case directly relates to its implementability, so maintaining a leveling scheme will insure that use cases are implemented, tested, etc. at a consistent level. In alignment with this, we will maintain the following use case leveling criteria:
- Global statement
Example: manage patient's health - Use Case Level 0: most general, high level business process
Example: treat this patient for cancer - Use Case Level 1: next level of business flow, such as inter-department level
Example: treat this patient for cancer by using diagnostics, education, treatments, etc. - Use Case Level 2: specific enough to drive major model dimensions (static/information model, behavioral model, governance model, etc.) and can include some exception conditions
Example: treat this patient for cancer by ordering these lab tests, evaluating the results, customizing a treatment or treatment plan to specifically address concerns - Use Case Level 3: includes details of each exchange of information, as well as assumptions about system boundaries
Example: treat this patient for cancer by ordering these lab tests in the caEHR system
i. find the patient, if new add patient, if not check for update
ii. create request(s) for testing for patient, then evaluate the results,
ii-a. read the faxed copy of the result or
ii-b. receive notification in Provider email that a result is ready for viewing, etc... - Use Case Level 4: project-specific solution for exchanges detailed in use case level-3 (could be MSG, SOA, or both)
Example:Standard Process Flow
1. Provider Refers Patient for Cancer Treatment
2. Provider and Patient have an encounter
3. Provider evaluates Patient's condition, treatment plan, current statistics, requests diagnostics
4. Provider updates treatment plan
5. Patient is treated, outcomes documented
6. Flow returns to any of the above steps or patient is released from cancer treatment
Assumptions and Dependencies
Usability
The user interface shall be designed for ease-of-use by the designated end-users, shall use terms common to the user's normal business environment, and shall require little to no additional training on the system. Drop down menus, Google-like searches, and tooltips should be used wherever appropriate.
Accessibility
The user interface should be accessible via a web browser.
General Assumptions
Following is a list of basic assumptions:
- Federated Discovery Services: Knowledge Repository Services will be distributable and discoverable in a federated manner
- Security Considerations: services and underlying data will be secured using the caBIG security architecture
- Subscriptions/Notifications: services requiring subscription and notification functionality will be enabled by the caBIG pub/sub architecture
- ISO 11179 Ed 3: the Knowledge Repository will comply with ISO 11179 Ed 3 specifications. See here for our analysis.
- Ability to have non-administered items: the Knowledge Repository will provide for non-administered items in the ISO 11179 notion
- Duplication/identification: in compliance with the Federated Discovery Services assumption, reference of data, data duplication, and unique identification of data will be handled
Dependencies
TBD
Functional Requirements
Model Services
Some basic description of model services.
ID | Requirement | Source | Release | ||
|---|---|---|---|---|---|
MOS-1 | The Model Service MUST support the abilities to record new model elements. | --- | |||
MOS-2 | The Model Service MUST support the abilities to record new assertions. | --- | |||
MOS-3 | The Model Service MUST support the abilities to record new rules. | --- | |||
MOS-4 | The Model Service SHOULD support the abilities to record queries. | --- | |||
MOS-10 | The Model Service MUST allow for the discovery of models based on querying model parts. | --- | |||
MOS-11 | The Model Service MAY support the federated discovery of models. | --- | |||
MOS-12 | The Model Service SHOULD allow the discovery of related model parts. | --- | |||
MOS-20 | The Model Service MUST support the comparison of model parts. | --- | |||
MOS-21 | The Model Service MUST support the harmonization of models through the comparison of model parts. | --- | |||
MOS-30 | The Model Service SHOULD support the merging of different parts of different models. | --- | |||
MOS-40 | The Model Service MAY support the graphical visualization of models. | --- | |||
MOS-50 | The Model Service MUST support the versioning of models. | --- | |||
MOS-60 | The Model Service MUST allow the retiring of models. | --- | |||
MOS-70 | The Model Service MUST allow the of updating of parts of a model. | --- | |||
MOS-80 | The Model Service MUST allow the deletion/unregistering of models. | --- | |||
MOS-90 | The Model Service SHOULD support the transformation of models. | --- | |||
MOS-100 | The Model Service SHOULD support the validation of models. | --- | |||
MOS-110 | The Model Service MUST support the reuse of model parts. | --- | |||
MOS-111 | The Model Service MUST support the entire reuse of direct copies of | ||||
ID | Requirement | Source | Release | ||
MOS-1 | The Model Service MUST support the abilities to record new model elements. |
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MOS-2 | The Model Service MUST support the abilities to record new assertions. |
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MOS-3 | The Model Service MUST support the abilities to record new rules. |
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MOS-4 | The Model Service SHOULD support the abilities to record queries. |
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MOS-10 | The Model Service MUST allow for the discovery of models based on querying model parts. | --- | |||
MOS-11 120 | The Model Service MAY MUST support the federated discovery extension of modelsmodel parts. | --- | |||
MOS-12 121 | The Model Service SHOULD MUST allow the discovery extension of related model partsclasses. | --- | |||
MOS-20 122 | The Model Service MUST support allow the comparison extensions of model partspart relationships. | --- | |||
MOS-21 123 | The Model Service MUST support SHOULD allow the harmonization of models through the comparison of model partsextension of attribute value lists. | --- | |||
MOS-30 130 | The Model Service SHOULD support the merging constraining of different model parts of different models. | --- | |||
MOS-40 131 | The Model Service MAY support the graphical visualization of modelsSHOULD allow for classes to be subsetted. | --- | |||
MOS-50 132 | The Model Service MUST support the versioning of modelsSHOULD allow for attribute value lists to be subsetted. | --- | |||
MOS-60 140 | The Model Service MUST allow the retiring of modelssupport the discovery of services related by model similarities. | --- | |||
MOS-70 150 | The Model Service MUST allow SHOULD support the of updating of parts of a modeldiscovery of related documentation. |
| --- |
Metadata Services
Some basic description of metadata services.
ID | Requirement | Source | Release | |||
|---|---|---|---|---|---|---|
MDS-1 | The Metadata Service MUST support the notion of data elements | MOS-80 | The Model Service MUST allow the deletion/unregistering of models. |
| --- | |
MDS-2 MOS-90 | The Model Metadata Service SHOULD support MUST allow the transformation recording of modelsdata elements. | --- | ||||
MOS MDS-100 3 | The Model Service SHOULD support the validation of modelsMetadata Service MUST allow new data element assertions to be made. | --- | ||||
MOS MDS-110 4 | The Model Metadata Service MUST support the reuse of model partsallow for data elements to be updated. |
| --- | |||
MDS-5 MOS-111 | The Model Service MUST support the entire reuse of direct copies of model partsMetadata Service MUST allow for data elements to be versioned. | --- | ||||
MOS MDS-120 6 | The Model Service MUST support the extension of model partsMetadata Service SHOULD allow for data element business rules to be validated. | --- | ||||
MOS MDS-121 7 | The Model Metadata Service MUST allow the extension of classesfor data elements to be retired. | --- | ||||
MOS MDS-122 8 | The Model Metadata Service MUST allow the extensions of model part relationshipsfor data elements to be deleted/rolled back. | --- | ||||
MOS MDS-123 9 | The Model Metadata Service SHOULD allow MUST support the extension of attribute value listsdiscovery of reusable data element content. | --- | ||||
MOS MDS-130 10 | The Model Metadata Service SHOULD support the constraining of model partsnotion of data element usage information. | --- | ||||
MOS MDS-131 11 | The Model Service SHOULD allow for classes to be subsettedMetadata Service MUST support metadata to be queried by data element. | --- | ||||
MOS MDS-132 12 | The Model Metadata Service SHOULD allow for attribute value lists to be subsettedsupport metadata to be queried by data element in a federated manner. | --- | ||||
MOS MDS-140 13 | The Model Metadata Service MUST support the discovery of services related by model similarities. comparison of data elements | --- | ||||
MOS MDS-150 14 | The Model Metadata Service SHOULD support the discovery of related documentationcreation of a new data element from an existing data element. |
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Metadata Services
Some basic description of metadata services.
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MDS-15 | ||||||
ID | Requirement | Source | Release | |||
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MDS-1 | The Metadata Service MUST support the notion discovery of related models by data elementselement. | --- | ||||
MDS-2 16 | The Metadata Service MUST allow the recording of data elementsSHOULD support the discover related metadata items by data element. | --- | ||||
MDS-3 17 | The Metadata Service MUST allow new SHOULD support the discovery of related services by data element assertions to be made. | --- | ||||
MDS-4 18 | The Metadata Service MUST allow for data elements to be updatedSHOULD support the discovery of related data element rules. | --- | ||||
MDS-5 19 | The Metadata Service MUST allow for data elements to be versionedSHOULD support the discovery of forms related by data element. | --- | ||||
MDS-6 101 | The Metadata Service SHOULD allow for data element business rules to be validatedMUST support the notion of value domains. | --- | ||||
MDS-7 102 | The Metadata Service MUST allow for data elements to be retiredthe recording of value domains. | --- | ||||
MDS-8 103 | The Metadata Service MUST allow for data elements new value domain assertions to be deleted/rolled backmade. | --- | ||||
MDS-9 104 | The Metadata Service MUST support the discovery of reusable data element contentallow for value domains to be updated. | --- | ||||
MDS-10 105 | The Metadata Service SHOULD support the notion of data element usage informationMUST allow for value domains to be versioned. | --- | ||||
MDS-11 106 | The Metadata Service MUST support metadata to be queried by data elementSHOULD allow for value domain business rules to be validated. | --- | ||||
MDS-12 107 | The Metadata Service SHOULD support metadata to be queried by data element in a federated mannerService MUST allow for value domains to be retired. | --- | ||||
MDS-13 108 | The Metadata Service MUST support the comparison of data elements allow for value domains to be deleted/rolled back. | --- | ||||
MDS-14 109 | The Metadata Service SHOULD MUST support the creation of a new data element from an existing data elementdiscovery of reusable value domain content. | --- | ||||
MDS-15 110 | The Metadata Service MUST SHOULD support the discovery of related models by data elementnotion of value domain usage information. | --- | ||||
MDS-16 111 | The Metadata Service SHOULD MUST support the discover related metadata items by data elementmetadata to be queried by value domain. | --- | ||||
MDS-17 112 | The Metadata Service SHOULD support the discovery of related services by data elementmetadata to be queried by value domain in a federated manner. | --- | ||||
MDS-18 113 | The Metadata Service SHOULD MUST support the discovery of related data element rules. comparison of value domains | --- | ||||
MDS-19 114 | The Metadata Service SHOULD support the discovery of forms related by creation of a new value domain from an existing data element. |
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MDS-101 | Value Domain |
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MDS-102 | Record (no rules) |
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MDS-103 | New assertions |
| 115 | The Metadata Service MUST support the discovery of related models by value domain. | --- | |
MDS-104 | Update |
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MDS-105 | Version |
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MDS-106 | Validate business rules |
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MDS-107 | Retire |
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MDS-108 | Delete/rollback |
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MDS-109 | Discover reusable content |
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MDS-110 | Usage information |
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MDS-111 | Search/query |
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MDS-112 | Federated search/query |
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MDS-113 | Compare |
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MDS-114 | Create new from existing |
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MDS-115 | Discover related models |
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MDS-116 | Discover related metadata items |
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MDS-117 | Discover related services |
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MDS-118 | Discover related rules |
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MDS-119 | Discover related forms |
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MDS-120 | Create subset/constrain |
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MDS-120 | Extend (create new from existing) |
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MDS-120 | Semantic transformations (Explicitly based on mapping e.g. to the same Value Meaning) |
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MDS-120 | Syntactic transformations ( Source representation to Target representation) |
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MDS-201 | Data Element Concept |
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MDS-202 | Record (no rules) |
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MDS-203 | New assertions |
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MDS-204 | Update |
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MDS-205 | Version |
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MDS-206 | Validate business rules |
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MDS-207 | Retire |
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MDS-208 | Delete/rollback |
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MDS-209 | Discover reusable content |
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MDS-210 | Usage information |
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MDS-211 | Search/query |
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MDS-212 | Federated search/query |
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MDS-213 | Compare |
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MDS-214 | Create new from existing |
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MDS-215 | Discover related models |
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MDS-216 | Discover related metadata items |
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MDS-217 | Discover related services |
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MDS-218 | Discover related rules |
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MDS-219 | Discover related forms |
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MDS-220 | Discover related data elements |
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MDS-222 | Discover related value sets |
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MDS-223 | Create data element from existing data element concept and value domain |
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MDS-224 | Create new data element concept from existing data element concept |
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Registry-Registry Service
116 | The Metadata Service SHOULD support the discover related metadata items by value domain. | --- | |
MDS-117 | The Metadata Service SHOULD support the discovery of related services by value domain. | --- | |
MDS-118 | The Metadata Service SHOULD support the discovery of related value domain rules. | --- | |
MDS-119 | The Metadata Service SHOULD support the discovery of forms related by value domain. | --- | |
MDS-120 | The Metadata Service SHOULD support the ability to create a value domain through subsetting/constraining. | --- | --- |
MDS-121 | The Metadata Service SHOULD allow value domains to be extended through the creation of new from existing. | --- | --- |
MDS-130 | The Metadata Service SHOULD support semantic transformations that would be explicitly based on value domain mapping, e.g. to the same value meaning. | --- | |
MDS-131 | The Metadata Service MAY support syntactic transformations that would transform source value domain representation to target value domain representation. | --- | |
MDS-201 | The Metadata Service MUST support the notion of data element concepts. | --- | |
MDS-202 | The Metadata Service MUST allow the recording of data element concepts. | --- | |
MDS-203 | The Metadata Service MUST allow new data element concept assertions to be made. | --- | |
MDS-204 | The Metadata Service MUST allow for data element concepts to be updated. | --- | |
MDS-205 | The Metadata Service MUST allow for data element concepts to be versioned. | --- | |
MDS-206 | The Metadata Service SHOULD allow for data element concept business rules to be validated. | --- | |
MDS-207 | The Metadata Service MUST allow for data element concepts to be retired. | --- | |
MDS-208 | The Metadata Service MUST allow for data element concepts to be deleted/rolled back. | --- | |
MDS-209 | The Metadata Service MUST support the discovery of reusable data element concept content. | --- | |
MDS-210 | The Metadata Service SHOULD support the notion of data element concept usage information. | --- | |
MDS-211 | The Metadata Service MUST support metadata to be queried by data element concept. | --- | |
MDS-212 | The Metadata Service SHOULD support metadata to be queried by data element concept in a federated manner. | --- | |
MDS-213 | The Metadata Service MUST support the comparison of data element concepts | --- | |
MDS-214 | The Metadata Service SHOULD support the creation of a new data element concept from an existing data element concept. | --- | |
MDS-215 | The Metadata Service MUST support the discovery of related models by data element concept. | --- | |
MDS-216 | The Metadata Service SHOULD support the discover related metadata items by data element concept. | --- | |
MDS-217 | The Metadata Service SHOULD support the discovery of related services by data element concept. | --- | |
MDS-218 | The Metadata Service SHOULD support the discovery of related data element concept rules. | --- | |
MDS-219 | The Metadata Service SHOULD support the discovery of forms related by data element concept. | --- | |
MDS-220 | The Metadata Service MUST support the discovery of related data elements by data element concept. | --- | |
MDS-221 | The Metadata Service SHOULD support the discovery of related value sets by data element concept. | --- | |
MDS-230 | The Metadata Service SHOULD support the creation of a data element from an existing data element concept and value domain. | --- | |
MDS-231 | The Metadata Service SHOULD support the creation of a new data element concept from an existing data element concept. | --- |
Registry-Registry Service
ID | Requirement | Source | Release |
|---|---|---|---|
RRS-1 | The Registry-Registry service MUST support the import of content from one registry to another. | --- | |
RRS-10 | The Registry-Registry service MUST support the export of content in a convenient data format. | --- | |
RRS-20 | The Registry-Registry service SHOULD support the update of edited content from one registry to another. | --- | |
RRS-30 | The Registry-Registry service MAY support the search of one registry from another. | --- | |
RRS-40 | The Registry-Registry service MUST support content to be submitted from one registry to another. | --- | |
RRS-50 | The Registry-Registry service MUST support the registration of content from one registry to another. | --- | |
RRS-60 | The Registry-Registry service MUST support the updating of the registration of content from one registry to another. | --- | |
ID | Requirement | Source | Release |
RRS-1 | Import Content |
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RRS-10 | Export Content |
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RRS-20 | Update Content |
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RRS-30 | Search |
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RRS-40 | Submit Content |
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RRS-50 | Register Content |
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RRS-60 | Update Registration |
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General Service
ID | Requirement | Source | Release |
|---|---|---|---|
GEN-1 | Services SHOULD support the notion of annotating any data with well defined concepts. Annotate with concepts | --- | |
GEN-10 | Services SHOULD allow users to subscribe for notifications of changes to data. Subscribe to changes | --- | |
GEN-20 Reuse (classify/categorize) | Services MUST support the notion of data reuse. | --- |
Metadata Registry Tools
ID | Requirement | Source | Release |
|---|---|---|---|
MRT-1 | Clinician A Metadata Registry Tool MUST support a clinician friendly browser. | --- | |
MRT-10 | Information A Metadata Registry Tool MUST support an information specialist browser. | --- | |
MRT-20 | A Metadata Registry Tool SHOULD support a customizable browser. Customizable browser | --- | |
MRT-30 | Portal A Metadata Registry Tool MAY support a generalized portal that integrates various metadata registry tools. | --- | |
MRT-40 | Workflow A Metadata Registry Tool SHOULD allow workflow management to support ECCF artifact creation. | --- | |
MRT-50 | Interface A Metadata Registry Tool MUST support an interface of browser/editing models and metadata with modeling tools. | --- |
Non-functional Requirements
...
ID | Requirement |
|---|---|
SE-1 | The system must limit access to authorized individuals. |
SE-10 | Electronic Signatures should meet necessary requirements as described in 21 CFR part 11. |
SE-20 | The application will address section 508 of the Rehabilitation Act of 1973 where appropriate and reasonable. |
SE-30 | System developers must adhere to the caBIG™ caBIG Data Sharing & Intellectual Capital Policy and Procedures |
...
