2/19/2014 CDISC SHARE Requirements Page 1 of 23 Number Name Req ID Requirement Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role 110 The system shall support multiple con users. Exact numbers are not known at this time. Approximately 25-50 con Users may be developing content and 100-200 Users may be browsing / viewing content. 120 The system shall allow each user to be allocated one or more User Roles 130 The system shall always maintain at least one user with administrative rights (the System Administrator role) 140 The system shall permit a new user to be created within the system by a user with the System Administrator role. 150 The system shall allow a user to self-register with the system. 160 When a user self-registers the system shall support mechanisms to prevent spam users being created. 170 The system shall allocate a Read- Only role to a self-registered user. R1 TC 22 Load and Stress Testing NA NA NA No longer valid requirement. Users can request an account, but not self-register. NA NA NA No longer valid requirement. Users can request an account, but not self-register. NA NA NA No longer valid requirement. Users can request an account, but not self-register.
2/19/2014 CDISC SHARE Requirements Page 2 of 23 Number Name Req ID Requirement Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.2 Password Manage Users 2.1.2 Password Manage Users 2.1.2 Password Manage Users 2.1.2 Password Manage Users 2.1.2 Password Manage Users 2.1.2 Password Manage Users 2.1.2 Password 180 The system shall allow for a user to be deleted by a user with the System Administrator role. 190 The system shall permit a user with the System Administrator role to assign a role to a user. 195 The system shall provide a configurable map between a User Role and system functions and privileges 210 The system shall require that all users login to use any system function. 220 The system shall require that a user login consist of a username and a password. 230 The system will allow an administrator to set password policies regarding length, composition and expiration. 240 The system shall allow the user to select their username. 250 The system shall ensure usernames are unique. 260 The system shall allow a user with system administrative rights to reset a user's password. 270 The system shall allow a user to change their password. Users can be de-activated but not deleted. The test case tests the de-activation function.
2/19/2014 CDISC SHARE Requirements Page 3 of 23 Number Name Req ID Requirement Manage Users 2.1.3 User Profiles The system shall allow additional information to be associated with a user account (the User Profile) consisting of Manage Users 2.1.3 User Profiles 311 a) Email address (required). Manage Users 2.1.3 User Profiles 312 b) Contact details including Job NA NA No longer valid title, phone numbers, company name, company address (optional) requirement. Not necessary to collect this info to set up a user. Manage Users 2.1.3 User Profiles 313 c) Experience And Interests including biographical details and therapeutic areas interested in (optional) Manage Users 2.1.3 User Profiles 314 d) Current Work Items assigned to (maintained by system) Manage Users 2.1.3 User Profiles 315 e) Work Items previously worked on (maintained by system) Manage Users 2.1.3 User Profiles 316 f) The mechanism to be used for System Notifications (via email, via the User s Dashboard, Both, others TBD) Manage Users 2.1.4 User Dashboard 410 The system shall have a Menu or Tree structure that will be used as a home screen when users log in. Manage Users 2.1.4 User Dashboard 420 The system shall provide a context sensitive help function Manage Users 2.1.4 User Dashboard 430 When a user logs in to the system shall display the User Dashboard Manage Users 2.1.4 User Dashboard 440 The content of the User Dashboard shall be individually configurable by each user NA R1 TC 19 General User Interface R1 TC 23 View Help Information No longer a valid requirement. This information isn't necessary for setting up a new user.
2/19/2014 CDISC SHARE Requirements Page 4 of 23 Number Name Req ID Requirement Manage Users 2.1.4 User Dashboard A User Dashboard shall be capable of displaying: Manage Users 2.1.4 User Dashboard 451 a) All notifications Manage Users 2.1.4 User Dashboard 452 b) All Work Items to which the user is allocated Manage Users 2.1.4 User Dashboard 453 c) Recent updates to system content Manage Users 2.1.4 User Dashboard 454 d) Other information TBD during requirements phase Manage 2.2.1 Manage Work Items 510 The system shall allow authorized user to create, read, update and delete Work Items. Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items 520 The system shall enable configurable workflows depending upon business rules and user groups, with visual workflow management capabilities. 530 The system shall enable automated configurable email alerts, triggering of processes and notifications based on events and triggers Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items 540 The system shall provide online support for dynamic setup of business rules and workflow configuration The system shall enable authorized users to control the following associated with workflows: Manage 2.2.1 Manage Work Items 551 a) Assign Work Items to a user, user group, or a role
2/19/2014 CDISC SHARE Requirements Page 5 of 23 Number Name Req ID Requirement Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items Manage 2.2.1 Manage Work Items Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and 552 b) Create and manage users, user groups, and roles 553 c) Assign deadlines to a Work Item 554 d) Create and manage alerts, reminders,and escalations to a Work Item 555 e) Manage order of tasks to Work Items 556 f) Addition of manual tasks which may need to occur outside of the SHARE MDR environment The system shall provide functionality to create and manage : 611 a) ISO 21090 Data Type Definition 612 b) Integrated BRIDG / ISO 21090 Template 613 c) Research Concept Intentionally left blank 614 d) Code List R1 TC 2.1 Add a new codelist 615 e) Code List Subset R1 TC 2.1 Add a new codelist Available in R1 but not tested until post R1.
2/19/2014 CDISC SHARE Requirements Page 6 of 23 Number Name Req ID Requirement Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2 Creating and Manage 2.2.2.1 Create a Standard Object Manage 2.2.2.1 Create a Standard Object Manage 2.2.2.1 Create a Standard Object 616 f) Operational Collection (with associated variable metadata and rules) 617 g) Versioned Standard ( e.g., SDTM, CDASH, ADaM) R1 TC 3 Add a new domain R1 TC 3 Add a new standard 618 h) Associations Available in R1 but not tested until post R1. 620 The system shall enforce an Object State Machine for Standard Objects 630 The system shall be able to provide a wiki style notes/comments section for any Standard Object, into which ad-hoc information can be inserted. 640 The system shall enforce version management for each Standard Object in accordance with an Object State Machine 710 The system shall provide mechanisms to assist in the prevention of duplicate object definitions. 720 The system shall permit a Standard Object to be created with its associated attributes and relationships. 730 Upon creation, a Standard Object shall be placed into a draft state R1 TC 18 Confirm lifecycle states of assets R1 TC 19 General User Interface R1 TC 18 Confirm lifecycle states of assets R1 TC 21 Prevent Duplicate Asset Creations R1 TC 3 Add a new domain R1 TC 3 Add a new domain
2/19/2014 CDISC SHARE Requirements Page 7 of 23 Number Name Req ID Requirement Manage 2.2.2.1 Create a Standard Object Manage 2.2.2.1 Create a Standard Object Manage 2.2.2.2 Viewing and Comparing of Manage 2.2.2.2 Viewing and Comparing of Manage 2.2.2.2 Viewing and Comparing of Manage 2.2.2.2 Viewing and Comparing of 750 When Research Concepts are created, the system shall ensure that the structure of the Research Concept is based on one of the Integrated BRIDG / ISO 21090 Templates present in the system 760 When constructing a Research Concept, the system shall provide assistance to the user based upon the applicable Integrated BRIDG / ISO 21090 Template (e.g, through the use of a wizard.) 810 The system shall be capable of presenting multiple Standard Objects side by side to permit comparison. 820 The system shall provide the ability to reconcile differences across multiple of the same type. 830 The system shall allow internal content to be browsed and searched while working on other 840 The system shall allow External Controlled to be browsed and searched while working on other R1 TC 1 Search, Browse R1 TC 1 Search, Browse R1 TC 5 Change and delete domains, variables, and codelists
2/19/2014 CDISC SHARE Requirements Page 8 of 23 Number Name Req ID Requirement Manage 2.2.2.3 ISO 21090 Data Type Definition Manage 2.2.2.3 ISO 21090 Data Type Definition Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates Manage 2.2.2.4 Integrated BRIDG / ISO 21090 Templates 910 The system shall permit the ability to create constrained versions of ISO21090 datatypes (e.g. ST.SIMPLE is a constrained version of ST that is included in ISO21090). 920 The system shall permit a Data Type attribute to be deleted 1010 The system shall permit one or more BRIDG classes to be associated into a Template. The lineage back to the BRIDG classes must be maintained 1020 The system shall permit a BRIDG class to be deleted from a Template 1030 The system shall permit a BRIDG class attribute to be selected for use in the Template 1040 The system shall enable the definition of Rules and Constraints (e.g., optional, mandatory, conditions) to be applied to the BRIDG class attributes 1050 The system shall enable the association of Code Lists (or Code List Subsets) to BRIDG class attributes 1060 The system shall enable the definition of Rules (e.g., optional, mandatory, conditions) to be applied to Code List Items
2/19/2014 CDISC SHARE Requirements Page 9 of 23 Number Name Req ID Requirement Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept Manage 2.2.2.5 Research Concept 1070 The system shall permit a BRIDG class attribute to be deleted from a Template 1110 The system shall permit a BRIDG class to be deleted from a Research Concept. 1120 The system shall permit a BRIDG class attribute to be selected for use in the Research Concept. 1130 The system shall enable the definition of Rules (e.g., optional, mandatory, conditions) to be applied to the BRIDG class attributes 1140 The system shall enable the association of Code Lists (or Code List Subsets) to BRIDG class attributes 1150 The system shall be able to represent Code List Values as value level metadata for SDTM and ADaM. (e.g., VSTESTCD Code List Values (Weight, BMI, Pulse) represented as metadata associated with their respective results in VSORRES, within a Vital Signs data set). 1160 The system shall enable the definition of Rules (e.g., optional, mandatory, conditions, etc) to be applied to Code List Items
2/19/2014 CDISC SHARE Requirements Page 10 of 23 Number Name Req ID Requirement Manage 2.2.2.5 Research Concept 1170 The system shall permit a BRIDG class attribute to be deleted from a Research Concept Manage 2.2.2.6 Code Lists 1210 The system shall be able to access valid value lists (Code Lists) that come from external terminology services such as NCI EVS. Manage 2.2.2.7 Code List Subsets (Value Lists) Manage 2.2.2.7 Code List Subsets (Value Lists) Manage 2.2.2.7 Code List Subsets (Value Lists) Manage 2.2.2.7 Code List Subsets (Value Lists) Manage 2.2.2.7 Code List Subsets (Value Lists) Manage 2.2.2.8 Operational Collection 1310 The system shall be able to create subsets of valid value lists that are specific to one or more research concepts. 1320 The system shall permit modifications of a Code List Subset by either adding or removing a Code List Item 1330 All items within a Code List Subset must belong to a single parent Code List 1340 A Code List Subset must retain its lineage to its associated external terminology source, including the version of the source code list 1350 The Code List Subset may be associated with one or more 1410 The system shall permit a Research Concept to be deleted from an Operational Collection R1 TC 11 Confirm - online - Controlled Terminology R1 TC 11 Confirm - online - Controlled Terminology R1 TC 5 Change and delete domains, variables, and codelists R1 TC 11 Confirm - online - Controlled Terminology R1 TC 11 Confirm - online - Controlled Terminology R1 TC 11 Confirm - online - Controlled Terminology
2/19/2014 CDISC SHARE Requirements Page 11 of 23 Number Name Req ID Requirement Manage 2.2.2.8 Operational Collection Manage 2.2.2.8 Operational Collection Manage 2.2.2.8 Operational Collection Manage 2.2.2.8 Operational Collection Manage 2.2.2.8 Operational Collection Manage 2.2.2.9 Versioned Standard Manage 2.2.2.9 Versioned Standard Manage 2.2.2.9 Versioned Standard 1420 The system shall permit a Research Concept to be added to an Operational Collection 1430 The system shall permit a rule to be deleted from an Operational Collection 1440 The system shall permit a rule to be added to an Operational Collection 1450 The system shall permit an existing Operational Collection rule to be modified 1460 The system shall permit the creation of an Operational Collection which is comprised of pointers to other Operational Collections (nesting). For examples, there may be a CRF collection with multiple panels of repeated information (which may also be Operational Collections). 1510 The system shall permit an Operational Collection to be deleted from a Versioned Standard 1520 The system shall permit an Operational Collection to be added to a Versioned Standard 1530 The system shall permit a rule to be deleted from a Versioned Standard R1 TC 3 Add a new domain R1 TC 5 Change and delete domains, variables, and codelists R1 TC 3 Add a new domain Available in R1 but not tested until post R1. Available in R1 but not tested until post R1. Available in R1 but not tested until post R1. Domains are operational collections, nested under versioned standards, which are also operational collections. Available in R1 but not tested until post R1
2/19/2014 CDISC SHARE Requirements Page 12 of 23 Number Name Req ID Requirement Manage 2.2.2.9 Versioned Standard Manage 2.2.2.9 Versioned Standard 1540 The system shall permit a rule to be added to a Versioned Standard 1550 The system shall permit an existing Versioned Standard rule to be modified Manage 2.2.2.10 Assocations 1610 When creating Integrated BRIDG / ISO 21090 Templates, the system shall maintain the associations defined by BRIDG. Manage 2.2.2.10 Assocations 1620 When creating a Research Concept, the system shall maintain the associations defined in the Integrated BRIDG / ISO 21090 Template. Manage 2.2.2.10 Assocations 1630 When creating an Operational Collection, the system shall maintain the associations defined in the Research Concepts. Manage 2.2.2.10 Associations 1640 When creating a Versioned Standard, the system shall maintain the associations defined in the Operational Collections. Manage 2.2.2.10 Associations 1650 The system shall be able to represent associations between at any level (e.g., Operational Collection to Operational Collection, SDTM to SDTMIG, CDASH to SDTM, etc) Manage 2.2.3 Audit An audit trail entry shall consist of: Manage 2.2.3 Audit 1711 a) Who performed the action Manage 2.2.3 Audit 1712 b) What action was performed R1 TC 3 Add a new domain R1 TC 2 Stick to the Stack (aka create new variable) Available in R1 but not tested until post R1 Available in R1 but not tested until post R1
2/19/2014 CDISC SHARE Requirements Page 13 of 23 Number Name Req ID Requirement Manage 2.2.3 Audit 1713 c) Why the action was performed Manage 2.2.3 Audit 1714 d) When the action was performed Manage 2.2.3 Audit An audit trail shall be maintained for the following system actions Manage 2.2.3 Audit 1721 a) When a user logs in to the system Manage 2.2.3 Audit 1722 b) When a user logs out from the system Manage 2.2.3 Audit 1723 c) When a user account is modified Manage 2.2.3 Audit 1724 d) When a user is added to a Work Item Manage 2.2.3 Audit 1725 e) When a user is removed from a Work Item Manage 2.2.3 Audit 1726 f) When a Work Item is created Manage 2.2.3 Audit 1727 g) Requirement Deleted Manage 2.2.3 Audit 1728 h) When the state of a Work Item changes Manage 2.2.3 Audit 1729 i) When new content is added to a Work Item Manage 2.2.3 Audit 1730 j) When content is modified within Work Item Manage 2.2.3 Audit 1731 k) When a Standard Object is created Manage 2.2.3 Audit 1732 l) When new content is added to a Standard Object Manage 2.2.3 Audit 1733 m) When content is modified within a Standard Object Manage 2.2.3 Audit The system shall allow for the audit trail to be viewed:
2/19/2014 CDISC SHARE Requirements Page 14 of 23 Number Name Req ID Requirement Manage 2.2.3 Audit 1741 a) By user Manage 2.2.3 Audit 1742 b) By type of event Manage 2.2.3 Audit 1743 c) By date / time range Manage 2.2.3 Audit 1744 d) By Work Item Manage 2.2.3 Audit 1745 e) By Standard Object Manage 2.2.3 Audit 1746 f) Others TBD Using SHARE MDR 2.3.1 Search & Browse 1810 The system shall allow system content to be searched and viewed: R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse a) For R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse 1821 a. By State R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse 1822 b. By Version R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse 1823 c. Changes Since R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse 1824 d. By a SDTM or CDASH variable R1 TC 1 Search, Browse name being associated with it Using SHARE MDR 2.3.1 Search & Browse 1825 e. By a Code List being R1 TC 1 Search, Browse associated with it Using SHARE MDR 2.3.1 Search & Browse 1826 f. By content being present R1 TC 1 Search, Browse within a Standard Object Using SHARE MDR 2.3.1 Search & Browse 1827 g. By a combination of the above R1 TC 1 Search, Browse Using SHARE MDR 2.3.1 Search & Browse b) For Work Items The top level for this is 1810. This work item section is. Using SHARE MDR 2.3.1 Search & Browse 1831 a. By State Using SHARE MDR 2.3.1 Search & Browse 1832 b. By Version
2/19/2014 CDISC SHARE Requirements Page 15 of 23 Number Name Req ID Requirement Using SHARE MDR 2.3.1 Search & Browse 1833 c. Changes since Using SHARE MDR 2.3.1 Search & Browse 1834 d. By a User being associated with it Using SHARE MDR 2.3.1 Search & Browse 1835 e. By a combination of the above Using SHARE MDR 2.3.1 Search & Browse c) For the Audit Trial Using SHARE MDR 2.3.1 Search & Browse 1841 a. By the attributes within the audit trail Using SHARE MDR 2.3.1 Search & Browse 1842 b. By the contents held within the audit trail Using SHARE MDR 2.3.1 Search & Browse 1843 a. By a combination of the above Using SHARE MDR 2.3.1 Search & Browse d) For Users Using SHARE MDR 2.3.1 Search & Browse 1851 a. By the attributes held on each user Using SHARE MDR 2.3.1 Search & Browse 1852 b. By Work Item the user is associated with Using SHARE MDR 2.3.1 Search & Browse 1853 c. Inactive in a given time period or since a given time Using SHARE MDR 2.3.1 Search & Browse 1854 d. By a combination of the above Using SHARE MDR 2.3.1 Search & Browse 1860 e) For External Controlled Using SHARE MDR 2.3.1 Search & Browse 1870 f) The results of any search should be made available by the system for subsequent use by the user in another system function
2/19/2014 CDISC SHARE Requirements Page 16 of 23 Number Name Req ID Requirement Using SHARE MDR Using SHARE MDR Using SHARE MDR 2.3.2 Printing 1910 The system shall permit a user to print any information presented to them at any time while using the system. 2.3.3 Import and Export 2.3.3 Import and Export Using SHARE MDR 2.3.3 Import and Export Using SHARE MDR 2.3.3 Import and Export The system shall permit the content held to be exported: 2011 a) For inclusion into SDTM/CDASH human readable specifications in a Microsoft Word format. R1 TC 1 Search, Browse Confirm Exports are correct - Excel R1 TC 24 Export Word Compatible Format 2012 a) In an Excel spread sheet format R1 TC 14 Confirm Exports are correct - Excel 2013 b) In ODM v1.3.1 and Define-XML v2 R1 TC 15 Confirm XML Formats Define.xml and ODM XML (syntax, structure) are correct Using SHARE MDR Using SHARE MDR Using SHARE MDR Using SHARE MDR Using SHARE MDR 2.3.3 Import and Export 2.3.3 Import and Export 2.3.3 Import and Export 2.3.3 Import and Export 2014 c) In RDF/OWL Format 2015 d) In JSON Format 2016 e) Through a web service API R1 TC 25 Confirm Basic API ality The system shall permit an export R1 Confirm Exports to contain: are correct - Excel, 2021 a) All of the defined content R1 TC 12 Confirm - Exports - Excel, ODM, Define.xml
2/19/2014 CDISC SHARE Requirements Page 17 of 23 Number Name Req ID Requirement Using SHARE MDR 2.3.3 Import and Export Using SHARE MDR 2.3.3 Import and Export Using SHARE MDR 2.3.3 Import and Export 2022 b) A defined subset of the content 2023 c) Others TBD 2024 d) The system shall provide the ability to import SHARE Spreadsheets. R1 TC 12 Confirm - Exports - Excel, ODM, Define.xml NA The SHARE spreadsheets are spreadsheets developed by the early SHARE Team (pre 2013) to consolidate CDASH & SDTM, provide consistent variable definitions, and BRIDG mapping information. At the time of the requirements definition, the thinking was that these spreadsheets would be the official import source for SHARE. Since the contents of these spreadsheets were not vetted as standards, the decision was made to not use these as the "official" import source to SHARE. The handful of SHARE Spreadsheets available were imported, in part, into SHARE for investigational purposes.
2/19/2014 CDISC SHARE Requirements Page 18 of 23 Number Name Req ID Requirement Manage Reporting & Dissemination Manage Reporting & Dissemination Manage Reporting & Dissemination 2.4.1 Ad hoc Notifications 2.4.1 Ad hoc Notifications 2.4.2 Regular Notifications 2110 The system shall permit a user to request notification, using a System Notification, about any changes to a Standard Object 2120 The system shall permit a user to receive a System Notification whenever the state of a Standard Object changes 2210 The system shall allow users to sign up to a listserv Manage Reporting & Dissemination Manage Reporting & Dissemination Manage Reporting & Dissemination Manage Reporting & Dissemination Manage Reporting & Dissemination 2.4.2 Regular Notifications 2.4.2 Regular Notifications 2.4.2 Regular Notifications 2.4.2 Regular Notifications 2.4.2 Regular Notifications Manage System 2.5.1 SHARE MDR Framework 2220 The listserv shall be configured to at regular periods, send out information about updates and changes to system content When a user logs on to the system, the system shall display: 2231 a) a list of changes relevant to the user 2232 b) Changes in work items the user is assigned to 2233 c) New work items started since the user last logged on 2310 The system shall support the SHARE as shown in the above diagram. R1 TC 8 Confirm Framework
2/19/2014 CDISC SHARE Requirements Page 19 of 23 Number Name Req ID Requirement Manage System 2.5.1 SHARE MDR Framework Manage System 2.5.1 SHARE MDR Framework Manage System 2.5.1 SHARE MDR Framework 2320 The system shall constrain the creation of content to those objects defined by the SHARE MDR Framework. 2330 The system shall ensure that all content is consistent with the SHARE. 2340 The system shall provide for the maintenance of the objects defined within the SHARE R1 TC 8 Confirm Framework R1 TC 8 Confirm Framework R1 TC 8 Confirm Framework 2410 The system shall be able to import the ISO 21090 Datatype Standard 2420 The system shall be able to manage versions of ISO 21090 and propogate version updates to downstream objects. Available in R1 but not test until post R1. Q: Assuming we at CDISC will have the ability to import ISO 21090, what do we need to do to prepare? Answer 10/16/2013: see Req 2430 below. Available in R1 but not tested until post R1.
2/19/2014 CDISC SHARE Requirements Page 20 of 23 Number Name Req ID Requirement 2430 The system shall be able to import the BRIDG Model. 2440 The system shall be able to manage versions of the BRIDG Model. 2450 The system shall be able to propagate BRIDG version updates to downstream objects. 2460 The system shall be able to manage the need to make changes to the BRIDG model that have not been incorporated in BRIDG yet. These changes will then be submitted to the BRIDG Semantic Coordination Committee. Available in R1 but not test until post R1. Q: Assuming we at CDISC will have the ability to import BRIDG, what do we need to do to prepare? Answer 10/16/2013: This could be split across releases. There is an import button. For R1, we'll ensure Julie's load is correct. Available in R1 but not tested until post R1. Available in R1 but not tested until post R1. 2461 a) SHARE may add BRIDG classes that BRIDG is lacking 2462 b) SHARE may add attributes to BRIDG classes that BRIDG is lacking
2/19/2014 CDISC SHARE Requirements Page 21 of 23 Number Name Req ID Requirement 2463 a) SHARE may add BRIDG associations (e.g. due to the addition of SHARE BRIDG classes) 2464 b) SHARE may (rarely) change the datatype of some of the BRIDG attributes (we may change a datatype of CS to CD or we might change the datatype of the methodcode attribute from DSET<CD> to CD) 2465 c) SHARE may change the cardinality of some of the associations (though this would be to constrain the BRIDG cardinality or to correct as yet uncorrected errors in BRIDG 2466 d) SHARE may modify forward and reverse action names for associations 2467 e) SHARE may change the direction of associations 2468 f) SHARE may add or modify the notes attached to associations 2470 The system shall be able to track changes made to BRIDG that require submission to the BRIDG Semantic Coordination Committee for inclusion in a future release of BRIDG.
2/19/2014 CDISC SHARE Requirements Page 22 of 23 Number Name Req ID Requirement 2480 The system shall be able to utilize external terminology sources such as, but not limited to: R1 TC 11 Confirm - online - Controlled Terminology 2481 a) NCI Semantic tools NA At the time of the requirements definition, the NCI had plans to completely re-develop their suite of semantic tools. However, government budget limitations and organizational changes influenced the plans, and as of SHARE 1, the new suite of semantic tools is not yet available. 2482 b) NCI EVS R1 TC 11 Confirm - online - Controlled Terminology 2483 c) cadsr NA At the time of the requirements definition, the need to interface to cadsr was not clear. As of SHARE R1, the SHARE team has not identified any need to interface with cadsr. 2484 d) LOINC 2485 a) SNOMED CT
2/19/2014 CDISC SHARE Requirements Page 23 of 23 Number Name Req ID Requirement Manage System 2.5.3 Metrics The system shall provide metrics on: Manage System 2.5.3 Metrics 2511 a) The number of times an object is viewed Manage System 2.5.3 Metrics 2512 b) The number of times an object is included within an export Manage System 2.5.3 Metrics 2513 c) The number of relationships and types of relationships associated with a given object. Manage System 2.5.3 Metrics 2514 d) Metrics on user activity (number of users, login sessions, activities performed, etc) Manage System 2.5.4 Availability 2610 The system shall be accessible to the global user community. Manage System 2.5.4 Availability 2620 The system shall be accessible using standard desk-top browsers (Microsoft Internet Explorer, Firefox, Google Chrome, Apple Safari). Manage System 2.5.4 Availability 2630 The system shall be available 24 hours a day, 7 days a week Manage System 2.5.4 Availability 2640 The system shall make all information available in real-time Manage System 2.5.4 Availability 2650 The system shall allow for scheduled downtime maintenance periods R1 Confirm Metrics report R1 TC 16 Confirm Metrics report R1 TC 19 General User Interface R1 TC 2, 3, 4, 5 Add a new domain R1 TC 9 Review and document system maintenance plan We agreed to accept canned reports as-is for R1, so this report will not be ready for testing before YE. See e-mails of 11/3 with subject of "User Metrics Report". Tested during all Test Cases: TC 2, 3, 4, 5