1. caCORE Training Forms- based Metadata Curation Session 1 Course Number:1061 Duration: 90 Minutes Intended Audience: Metadata Curators – Using Forms Instructor: Jamie Parker and Jenny Brush ScenPro jkeller@scenpro.com jbrush@scenpro.com NCI CBIIT Liaison: Dianne Reeves reevesd@mail.nnih.gov

2. Session Details: Forms-based Metadata Session 1 Online Training Environment: Centra… Use these buttons (or choose from the Actions menu) to communicate with the trainer and other attendees. Example: Raise your hand to ask a question.

3. Session Details: Forms-based Metadata Session 1 Online Training Environment: Centra You can adjust what you see on screen by choosing from the View menu or by scrolling.

4. Session Details: Forms-based Metadata Session 1 Online Training Etiquette Be an active learner Ask lots of questions Avoid the temptation to multi-task Please keep your phone on MUTE Please do not put your phone on HOLD - disconnect from the teleconference to take another call Please state your name when asking a question or making a comment

5. Session Details: Forms-based Metadata Session 1 Prerequisites for this course Course 1000: Introduction to caCORE and caDSR Course 1010: Introduction to ISO/IEC 11179 Course 1020: Using the CDE Browser and UML Model Browser Course 1030: Using EVS Course 1040: Creating Well-formed Metadata and Metadata Business Rules All course materials are available through the caBIG Learning Management System (LMS) http://ncicbtraining.nci.nih.gov Register for courses Take quiz to receive credit for each course

6. Session Details: Forms-based Metadata Session 1 Session Outline Learning Objectives Lesson 1: Data Element Overview Lesson 2: Analyzing Forms to Find Metadata Lesson 3: Searching for Metadata Lesson 4: Evaluating Data Elements for Re-Use Lesson 5: Designating Data Elements Lesson 6: Curate Alternate Names and Definitions

7. Session Details: Forms-based Metadata Session 1 Course Learning Objectives When you leave today, you will be able to: Define a Data Element Describe how Data Elements are formed Identify the metadata standard used to guide metadata curation Describe how metadata is organized in the metadata repository Discuss how to decompose a question on a Case Report Form (CRF) or Data Collection Instrument (DCI) into a Data Element Access caDSR tools online to: Search for data elements that match questions on forms Evaluate candidates for re-use Search for data elements by their components Designate Data Elements for re-use in your Context Curate Alternate Names and Definitions of Administered items to reflect your needs

8. Lesson 1: Data Element Overview In this lesson you will learn how to: Define a Data Element Describe how Data Elements are formed Identify the metadata standard used to guide metadata curation Describe the NCI metadata registry List two ways to “re-use” metadata

9. Lesson 1: Data Element Overview Data Elements Defined A data element (DE) is a piece of metadata Definition: the set of attributes and descriptors used to identify, define, represent, and list the acceptable values for data that is being collected Example Data Element Person Education Level Type The descriptors for this data element include what it is, the question text, the definition, what group curated it, and any permissible values. Data Element details viewed in the CDE Browser

10. Lesson 1: Data Element Overview Data Element Construction A data element is metadata that includes both the conceptual entity (or thing) about which data is being collected (called a Data Element Concept), and its physical representation (called a Value Domain) NCI data elements are based on the ISO/IEC 11179 Metadata Standard Person Age Range Range Value Domain Data Element Data Element Concept Person Age Person Age Property Permissible Values 00 – 21 Years 22 – 45 Years 46 – 75 Years Representation Range Object Class Simplified Data Element Construct A common data element (CDE) is a synonym for a data element (DE). Common Data Elements are data elements that have potential for re-use.

11. Lesson 1: Data Element Overview Cancer Data Standards Repository At the NCI, our metadata repository is the caDSR (cancer Data Standards Repository) The caDSR conforms to the ISO/IEC 11179 metadata standard Metadata in the caDSR is organized and administered by Context Contexts are organization-specific work areas Context Administrators oversee the creation and maintenance of the metadata within their Context and acts as the main point of contact for context-level activities and decisions Metadata Curators use the caDSR tools to maintain and curate content within their Contexts. Example Contexts : Cancer Biomedical informatics Grid (caBIG Context) Center for Cancer Research (CCR Context) National Heart, Lung and Blood Institute (NHLBI Context) Clinical Data Interchange Standards Consortium (CDISC Context)

12. Lesson 1: Data Element Overview View caDSR Contexts in the CDE Browser You can view a complete list of caDSR Contexts in the CDE Browser Link: http://cdebrowser.nci.nih.govhttp://cdebrowser.nci.nih.gov

13. Lesson 1: Data Element Overview (Common) Data Elements: “Re-use” Data Elements may be re-used across Contexts through ‘designation’. Example: caBIG has designated a data element from the CCR Context for re-use in the caBIG Context. Example – You can view Designations in the CDE Browser Search Results The data element “Person Marital Status Category” was created by (is Owned By) the CCR Context. The caBIG Context Administrator designated (is Used By) the data element “Person Marital Status Category” for re-use in the caBIG Context.

14. Lesson 1: Data Element Overview “Re-use” of other Metadata Other Administered Items may be re-used freely across contexts Example: Re-use Data Element Concepts (DEC) and Value Domains (VD) from other Contexts when curating metadata No designation is required The CCR Curator searched for an existing Data Element Concept that was ‘Owned By’ the caBIG Context. The CCR Curator searched for an existing Value Domain that was ‘Owned By’ the CTEP Context. Example – In the Curation Tool, you can create new data elements by selecting existing metadata components

15. Lesson 1: Review… TRUE or FALSE: A data element (DE) is the set of attributes and descriptors used to identify, define, represent, and list the acceptable values for data that is being collected. At a high level, a Data Element is composed of two parts: _______________ What is the name of the metadata standard that we use to guide the creation and maintenance of NCI metadata? _______________ ? “representation” Data Element ? “thing”

16. Lesson 1: Answers… TRUE or FALSE: A data element (DE) is the set of attributes and descriptors used to identify, define, represent, and list the acceptable values for data that is being collected. Answer: TRUE At a high level, a Data Element is composed of two parts: Data Element Concept (DEC) Value Domain (VD) What is the name of the metadata standard that we use to guide the creation and maintenance of NCI metadata? ISO/IEC 11179 Metadata Standard Value Domain “representation” Data Element Data Element Concept “thing”

17. Lesson 1: Review continued caDSR stands for: _____ ____ _______ ________ What purpose and function does the caDSR serve? Fill in the blank: “I can re-use a data element from another Context by ________ing that data element.” TRUE or FALSE: “I can re-use Data Element Concepts (DEC) and Value Domains (VD) freely from other Contexts when curating metadata. No designation is required.”

18. Lesson 1: Answers continued caDSR stands for: Cancer Data Standards Repository What purpose and function does the caDSR serve? Answer: It is where we store ISO/IEC 11179 compliant metadata. Fill in the blank: “I can re-use a data element from another Context by designating that data element.” TRUE or FALSE: “I can re-use Data Element Concepts (DEC) and Value Domains (VD) freely from other Contexts when curating metadata. No designation is required.” Answer: TRUE

19. Lesson 2: Analyzing Forms to Find Metadata In this lesson, you will learn how to: Identify the information (from a question on a form) that will help you create a Data Element Concept Identify the information (from a list of responses) on a form that will help you create a Value Domain Discuss how to transform a question from a Case Report Form (CRF) into a complete Data Element

20. Lesson 2: Finding Metadata on Forms Finding Metadata on Forms Metadata can can be found on forms, e.g. Case Report Forms (CRF) and other data collection instruments (DCI) for data collection. Example – C3D Case Report Form “Eligibility Checklist” Data Elements that appear on the Standard caBIG Protocol forms can be found using the CDE Browser in the caBIG Context – under Protocol Forms

21. Lesson 2: Analyzing Forms to Find Metadata Example Form Mountain Lake Oncology Center Demography Patient Gender Male Female Unknown Date of Birth Education LevelEthnicity Hispanic or Latino Not Hispanic or Latino Unknown Not Reported __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD

22. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Permissible Value, Meaning & Description Lesson 2: Analyzing Forms to Find Metadata Transforming Questions into Data Elements Conceptual Domain Value Domain Representation Term Representation Term Qualifier(s) Data Element Object Class Property Object Class Qualifier(s) Property Qualifier(s) Data Element Concept

23. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Lesson 2: Analyzing Forms to Find Metadata Step 1: Identify the Question Topic What are we collecting information about? The topic of this question is “Person” – that is the thing we are collecting information about. Person

24. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Lesson 2: Analyzing Forms to Find Metadata Step 2: Identify the Specifics What specific characteristics are we collecting information about? The specific information we are looking for is a Person’s “Education Level”. Person Education Level

25. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Permissible Value, Meaning & Description Conceptual Domain Value Domain Representation Term Representation Term Qualifier(s) Data Element Object Class Property Object Class Qualifier(s) Property Qualifier(s) Data Element Concept Person Education Level Person Education Level Lesson 2: Analyzing Forms to find Metadata Step 3: Map the Question to a Data Element Concept

26. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Lesson 2: Analyzing Forms to Find Metadata Step 4: Identify how to Represent the Answer How are we going to represent a person’s education level? This list of possible responses is a list of education “types”. We call this a “Representation Term”. There are 37 preferred (primary) representation terms in the caDSR. Type (of education)

27. Lesson 2: Analyzing Forms to Find Metadata Note: Preferred Representation Terms Example – Searching for a Representation Term in the Curation Tool brings up The list of 37 preferred Representation terms.

28. Lesson 2: Analyzing Forms to Find Metadata Note: Primary Representation Terms Anatomic Site Category Code Count Date Date/Time Dose Duration Float Frequency Grade Identifier Ind-2 Ind-3 Ind-3b Ind-4 Indicator Integer Interval Measurement Name Number Range Rate Reason Result Scale Score Source Specify Stage Status Text Time Type Unit of Measure Value https://wiki.nci.nih.gov/x/yZV8

29. Lesson 2: Analyzing Forms to Find Metadata Qualifying Representation Terms Qualifier Concepts are used to further clarify a primary Representation Term Provide more specifics about the Representation Term You can have multiple Qualifiers Take for example our question - Education Level We know the Representation Term is Type – but what Type Blood Type Data Type Education Level Type Qualifiers add context to our primary Representation Terms Note: Qualifier terms are often similar to the terms used to construct a DE – for example: DE = Person Education Level VD = Education Level Type (Education and Level are qualifiers for Type) DEC = Person Education Level Education Level Type Best Practice - remove the redundant terms Person Education Level Education Level Type = Person Education Level Type

30. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Permissible Value, Meaning & Description Person Education Level Type 1 st Grade -- completed first grade 2 nd Grade – completed second grade 3 rd Grade – completed third grade… Conceptual Domain Value Domain Representation Term Representation Term Qualifier(s) Type Person Education Level Property or Attribute Data Element Object Class Property Object Class Qualifier(s) Property Qualifier(s) Data Element Concept Lesson 2: Analyzing Forms to Find Metadata Step 5: Map the Responses to a Value Domain

31. Form (CRF or DCI) Level of Education: __ 1 st Grade __ 2 nd Grade __ 3 rd Grade __ 4 th Grade __ 5 th Grade __ 6 th Grade __ Junior High __ High School __ Some College __ Associates Degree __ Bachelors Degree __ Masters __ PhD Person Education Level Type Permissible Value, Meaning & Description Person Education Level Type 1 st Grade -- completed first grade 2 nd Grade – completed second grade 3 rd Grade – completed third grade… Conceptual Domain Value Domain Representation Term Representation Term Qualifier(s) Type Person Education Level Property or Attribute Data Element Object Class Property Object Class Qualifier(s) Property Qualifier(s) Data Element Concept Person Education Level Person Education Level Lesson 2: Analyzing Forms to Find Metadata Step 6: Combine the DEC and VD to form a Data Element

32. Lesson 2: Analyzing Forms to Find Metadata Applying what you have learned

33. What am I describing? [Object Class] - Person What is its characteristic? [Properties] - Race What am I describing? [Object Class] - Person What is its characteristic? [Properties] - Race Lesson 2: Analyzing Forms to Find Metadata Applying what you have learned continued

34. What is the representation? Category What is the data type? Character How is representation used? On a form What is the representation? Category What is the data type? Character How is representation used? On a form Permissible Values Lesson 2: Analyzing Forms to Find Metadata Applying what you have learned continued How am I collecting the answer?

35. Question: Data Element Concept (Object Class, Property) is: Person Race Value Domain (Representation, Data type) is : Person Race Category Data Element: Person Race Person Race Category = Person Race Category Lesson 2: Analyzing Forms to Find Metadata Results of a decomposition

36. Lesson 2: Analyzing Forms to Find Metadata Review Questions The question on a form is analyzed to create what piece of a data element? _______ ________ ________ The list of possible responses on a form is analyzed to create what piece of a data element? _______ _________ TRUE or FALSE: When selecting a Representation Term for a Value Domain, you may pick any concept you want for the primary concept.

37. Lesson 2: Analyzing Forms to Find Metadata Review Questions - Answers The question on a form is analyzed to create what piece of a data element? Data Element Concept The list of possible responses on a form is analyzed to create what piece of a data element? Value Domain TRUE or FALSE: When selecting a Representation Term for a Value Domain, you may pick any concept you want for the primary concept. Answer: FALSE You must use one of the 37 approved primary concepts to create your representation term Bonus: list 3 of these approved concepts

38. Lesson 3: Searching for Metadata In this lesson you will learn how to: Discuss when it is best to use the CDE Browser to search for existing metadata Discuss when it is best to use the Curation Tool to search for existing metadata Discuss when it is best to use EVS to search for existing Metadata

39. CDE Browser http://cdebrowser.nci.nih.gov/ Search by all attributes Download content (all administered items) Curation Tool http://cdecurate.nci.nih.gov/ Navigate the relationships between administered items Lesson 3: Searching for Metadata caDSR Tools with Search Capabilities

40. Lesson 3: Searching for Metadata Searching with the CDE Browser CDE Browser Search http://cdebrowser.nci.nih.gov/ Use when: You are looking for Data Elements You need to see all of the details for a Data Element and it’s components You need to compare Data Elements and evaluate them You are selecting Data Elements for use on a Form Search Features: Results list are based on data elements Tree search gives you the caBIG Standards You can download Data Elements and all of their components (EXCEL or XML) Access Formbuilder through the CDE Browser Doesn’t display retired elements

41. Lesson 3: Searching for Metadata Searching with the CDE Browser Two kinds of Searches in the Browser Tree Search (by Context) Text Search (by Detail)

42. Lesson 3: Searching for Metadata Searching the CDE Browser –Tree Search Example Tree Search – look for the Data Standards in caDSR Select the caBIG Context  Data Standards  Standard to view the list of data elements that are common across ALL contexts.

43. Lesson 3: Searching for Metadata Searching the CDE Browser – Text Search Example Text Search – look for Person Education data elements using wildcards (*) Using wild cards in your search delivers better search results Search results = 31 Note: “Name” searches the Long Name, Preferred Question Text, Definition, and any alternate names and definitions.

44. Lesson 3: Searching for Metadata Comparing CDEs in the CDE Browser Comparing CDEs Example Curator searches *education* 31 Search results are returned Select the CDEs to compare Select the “Compare CDEs” Button

45. Lesson 3: Searching for Metadata Comparing Selected CDEs Horizontal Comparison of CDEs View DECs, VD, Permissible Values Select the Done button to return to the CDE Browser Search Window

46. Lesson 3: Searching for Metadata Successful Searching Best Search by specific Public ID Recommended Use a combination of search fields with wildcards (*) Use the Advanced Search feature Example: *text string* + permissible value + workflow long name/short name: *education* permissible value: 1 st grade workflow: RELEASED If the results are not what you need, remove one criteria (i.e. permissible value)

47. Lesson 3: Searching for Metadata Successful Searching – Using the Advanced Search Long name: *education* Permissible Value: 1 st grade Workflow Status: RELEASED 1 Result Data Element Name: Person Education Level Type Workflow: RELEASED Permissible value: 1st Grade

48. Lesson 3: Searching for Metadata Successful Searching - Standards Find the Data Standards in caDSR Select the caBIG Context  Classifications  Data Standards  Standard to view the list of data elements that are common across ALL contexts.

49. Lesson 3: Searching for Metadata Not So Successful Searching Limited Success Search by Name Example: *Date of Birth* (better would be *date*birth*) Note: searches are order specific date*birth different than birth*date Search by Question Text Example: evaluation date (returns MANY results) Search by Keyword without a wildcard (*) Example: Adverse Event (may return no results)

50. Lesson 3: Searching for Metadata Searching with the Curation Tool Curation Tool Search http://cdecurate.nci.nih.gov/ Use when: You can’t find what you’re looking for in the CDE Browser You are searching for other metadata Data Element Concepts Value Domains Object Class, Property You are searching for Administered Items created by specific people Your results list can be data element OR other administered items You are looking for “associated” administered items (using the “Get Associated” search feature) You want to search by date, or curator name

51. Lesson 3: Searching for Metadata Searching with the Curation Tool In the Curation Tool, you can search for most types of Administered Items (Data Element, Data Element Concept, Value Domain, Object Class, Property, etc.) Unlike the CDE Browser, your results list in the Curation Tool are the administered item you are searching for. For example, if you search for a Value Domain your results list is all Value Domains.

52. Lesson 3: Searching for Metadata Searching with the Curation Tool “Get Associated” Example Curator searches for the Object Class “Person” 4 Search results are returned Select the “person” object class that is RELEASED (checkbox) Select the “Get Associated  Data Element Concepts” at the top of the screen. Curation Tool returns the 200 Data Element Concepts that use “Person” as their Object Class.

53. Lesson 3: Searching for Metadata Searching with the Curation Tool Curation Tool displays the list of DECs. From here, you can select DECs and “Get Associated” Data Elements, then select “Get Associated” and get Value Domains, etc.

54. Lesson 3: Searching for Metadata Search Conceptual Domains Conceptual Domains are a way to group metadata components. Data Element Concepts (DEC) and Value Domains (VD) are both assigned Conceptual Domains. Example – In the Curation Tool select a Conceptual Domain to search for items belonging to that conceptual domain.

55. As a metadata curator, what is the tool you will use most often to search for existing data elements in the caDSR? _____ ____________ What are the best set of data elements for re-use? TRUE or FALSE: The CDE Browser does not display retired and deleted data elements by default. What is one unique search capability in the Curation Tool? ADD EVS QUESTION Lesson 3 - Review

56. As a metadata curator, what is the tool you will use most often to search for existing data elements in the caDSR? Answer: CDE Browser What are the best set of data elements for re-use? Standard Data Elements (can be found under caBIG Context in the Context Tree) TRUE or FALSE: The CDE Browser does not display retired and deleted data elements by default. TRUE What is the unique search capability in the Curation Tool? Searching by “get associated” – navigating the relationships between metadata. Lesson 3 - Answers

57. Lesson 3 - Bonus Questions Where are the data standards located? Sometime when searching a data element in the CDE browser you get a different number of results, for example 21 then when you search for the exact same data element in the Curration tool, for example 27 – how is that possible?

58. Lesson 3 - Bonus Questions -Answers Where are the data standards located? ANSWER: The data standards can be found in the CDE Browser under the caBIG Context (context tree)>>Classifications>>Data Standards>>Standard Sometime when searching a data element in the CDE browser you get a different number of results, for example 21 then when you search for the exact same data element in the Curation tool, for example 27 – how is that possible? ANSWER: The Curation tool shows retired concepts and the CDE browser does not which explains the reason for the disparity in the results

59. Lesson 4: Evaluating Data Elements for Re-use In this lesson you will learn how to: Evaluate data elements for re-use Select the best match of a data element for your needs

60. Lesson 4: Evaluating Data Elements for Re-use Attributes of Well-formed Data Elements Attributes of a Well-formed Data Element: Workflow Status RELEASED Registration Status Standard Candidate Qualified Object Class, Property, Representation Term, and Permissible Values are based on NCI Thesaurus concepts NCI Thesaurus Concept Code Format: C # # # # # NCI Metathesaurus Concept Code Format: C # # # # # # # Note: Remember, when looking for re-usable data elements, Definition, Question Text and Name are less important matches

61. Lesson 4: Evaluating Data Elements for Re-use Data Element Attributes… Workflow Status RELEASED - Status assigned to new or modified Date Elements, and their associated Administered Components, that have been reviewed and approved by the owning Context's review process (by committee or other decision-maker). Released Administered Components must be fully specified and compliant with the ISO 11179 model and associated naming guidelines and conventions. The Compare CDEs button allows you to compare or evaluate multiple Data Elements

62. Lesson 4: Evaluating Data Elements for Re-use Data Element Attributes continued Registration Status Standard - the Administered Component has all necessary metadata, has met all quality requirements, and has been approved for usage in all contexts. Proposed – Met all quality requirements and is ready to be proposed for usage in all contexts Candidate - the Administered Component has all the necessary metadata, has met all quality requirements, and has been proposed for usage in all contexts. Qualified - the Administered Component has met all quality requirements, and is ready to be reviewed for usage in all contexts.

63. Lesson 4: Evaluating Data Elements for Re-use Evaluating Candidates for Re-use: Semantics… Scenario 1: You may find a perfect candidate for reuse, but there are no EVS concepts assigned to the Object Class or Property. What do you do? Option 1: Request that the owner version the CDE and include the concepts Option 2: Search for another Data Element match Option 3: Curate a new (different) CDE

64. Lesson 4: Evaluating Data Elements for Re-use Evaluating Candidates for Re-use: Semantics continued Scenario 2: You find a data element where the definition is different, the question text is different, but the concepts are perfect. What do you do? Use the current CDE, but create Alternate Definition and Alternate Question Text for your use Ask the owner to change the definition and question text

65. Lesson 4 - Review What Workflow Status should you be looking for when evaluating candidate data elements for re-use? What does it mean when a data element has a Registration Status of “Standard”? A well-formed data element concept has an object class, property based on…?

66. Lesson 4 - Answers What Workflow Status should you be looking for when evaluating candidate data elements for re-use? Released What does it mean when a data element has a Registration Status of “Standard”? Meets a Set of Criteria and has been vetted and approved by the caBIG Community A well-formed data element concept has an object class, property based on…? EVS Concepts

67. Lesson 5: Designating Data Elements In this lesson, you will learn how to: Define data element designation Discuss when it is appropriate to designate a Data Element for re-use Describe the process for designating one or more Data Elements Describe the process for removing designations from previous versions of a data element

68. Lesson 5: Designating Data Elements Designation Overview Designate a data element when you want to re-use that data element in your context Designations only apply if the CDE is NOT already in your context You do not need to designate to edit attributes Designating gives you the ability to edit some attributes of a Data Element Alternate Name Alternate Definition Alternate Question Text Classifications Designations are viewed in the CDE Browser and the CDE Curation Tool Designate Data Elements in the Curation Tool There are specific business rules about when you can designate a data element

69. Lesson 5: Designating Data Elements Designation Business Rules Only Data Elements can be designated You may designate Data Elements with the following Workflow Status: RELEASED APPROVED FOR TRIAL USE COMMITTEE SUBMITTED USED DRAFT MOD COMMITTEE APPROVED RELEASED NON-COMPLIANT This message appears in the Curation Tool if you attempt to designate a data element without an appropriate workflow status

70. Lesson 5: Designating Data Elements View Designations in the CDE Browser Designations appear in the “Used By Context” Column in the CDE Browser search results “Address City Name” is created by (“owned by”) DCP. It is designated (“used by”) CTEP and caBIG Example CDE Browser Search Results

71. Lesson 5: Designating Data Elements View Designations in the Curation Tool Designations appear in the “Used By Context” Column in Curation Tool search results “Person Address Name” is created by (“owned by”) CTEP. It is designated (“used by”) CIP, CCR, caBIG, SPORes, and NIDCR. Curation Tool - Search Results Screen

72. Lesson 5: Designating Data Elements Designate in the Curation Tool… Step 1: Search for Data Elements Step 2: Evaluate them for Re-use Step 3: Select Data Elements you want to re- use (select the check-box next to them) Step 4: Click the Designations button at the top of the screen. Curation Tool - Search Results Screen

73. Lesson 5: Designating Data Elements Designate in the Curation Tool continued 5 Step 5: Select your context from the drop down list “Designate in Context:” Step 6: Confirm the list of Data Elements below are the Data Elements you want to designate for re-use in your context Step 7: Select the “Update Used By Attributes” at the top of the screen. Curation Tool – Designations Screen

74. Lesson 5: Designating Data Elements Designate in the Curation Tool continued A confirmation message will be displayed You will see your context appear in the “Used By Context” column. Curation Tool - Updated Search Results Screen

75. Lesson 5: Designating Data Elements Remove Designations Remove Designations from previous versions of data elements, when a decision is made to re-use the new version. 5 Step 1: Select the context that the data elements are currently designated to. Step 2: Select the data elements to be removed from the designation Step 3: Select the “Remove Used By Attributes” button at the top of the screen. 5 Curation Tool - Designations Screen

76. Lesson 5 Review True or False: You can Designate a Data Element Concept Which one of the following workflow status cannot be designated RELEASED APPROVED FOR TRIAL USE DRAFT MOD RETIRED PHASED OUT RELEASED NON-COMPLIANT What is the Difference Between Owned By and Used By? Why Designate?

77. Lesson 5 - Answers True or False: You can Designate a Data Element Concept FALSE – only Data Elements can be designated Which one of the following workflow status cannot be designated RELEASED APPROVED FOR TRIAL USE DRAFT MOD RETIRED PHASED OUT RELEASED NON-COMPLIANT What is the Difference Between Owned By and Used By? Owned by is What context created the DE – Used by is which Context (s) are using by Designation the DE Why Designate? Designation allows a curator to add attributes to a DE not owned by the curators context – it allows the curator to create Alt Names, Alternate Name, Alternate Definition, Alternate Question Text, and Classifications

78. Lesson 6: Curate Alternate Names and Definitions In this lesson, you will learn how to: Identify at least three Administered Items that can have Alternate Names and Definitions Discuss the use of Alternate Names and Definitions Identify the caDSR Tool used to add Alternate Names and Definitions Describe the process for creating a new Alternate Definition Discuss the use of Alternate Question Text

79. Lesson 6: Curate Alternate Names and Definitions Overview of Alternate Names Alternate Names are one attribute of a Administered Item The following Administered Items can have Alternate Names Data Element Data Element Concept Value Domain Alternate Names are used in: External Systems Anyone with curator privileges can add an Alternate Name to a Data Element, Data Element Concept or Value Domain. A curator does not have to own the Administered Item to add an Alternate Name. Remember to DESIGNATE any Data Elements for which you are adding Alternate Names.

80. Lesson 6: Curate Alternate Names and Definitions When to Curate Alternate Names Scenario 1: I need a 20 character name to support my product (C3D), so I need to create an alternate name (Person Education Level Type = EDUC_LVL_TP) Scenario 2: I’m re-using a CDE from another context, but unfortunately the short name does not work for my group, so I can create an alternate name for use within my context.

81. Lesson 6: Curate Alternate Names and Definitions Overview of Alternate Definitions Alternate Definitions are one attribute of an Administered Item The following Administered Items can have Alternate Definitions Data Element Data Element Concept Value Domain Definitions can be: System Generated Standards Based Manually Curated Remember to designate any Data Elements for which you are adding Alternate Definitions.

82. Lesson 6: Curate Alternate Names and Definitions Definition Types – System Generated System Generated Definition Definitions for Data Elements are created by the Curation Tool, based on the definition from the Data Element Concept and Value Domain Value Domain and Data Element Concept definitions are created by the Curation Tool, based on the definition from the Object Class and Property (for the DEC) and Representation Term (for the VD). System Generated Definitions must be stored in the caDSR as the preferred OR alternate definition. Curation Tool - Edit Data Element Screen – System Generated Definition Example System- Generated Definition. Definitions from the DEC and VD are separated by underscores ( _ )

83. Lesson 6: Curate Alternate Names and Definitions Definition Types – Standards Based Standards Based Definition (Alternate) Verbatim definitions from a standard Example: You are curating the DICOM standard. You’ve created the definitions, but you also need the exact wording from the standard accessible in the caDSR. Create an Alternate Definition that is Standards Based.

84. Lesson 6: Curate Alternate Names and Definitions Definition Types – Manually Curated Manually Curated Definition Subject Matter Expert (SME) creates a clear, human readable definition. Example: Data Element- Alcohol Current Use Yes No Number Code Definition: Information related to the current use of alcohol._Affirmative response to a question or activity._No value exists._Number; a concept of quantity derived from zero and units; a numeral or string of numerals that is used for identification._A system of numbered categories for representation of data. (0=No; 1=Yes) [System-generated] Alternate Definition: A No/Yes code which indicates whether a respondent currently consumes alcohol. [Manually-curated]

85. Lesson 6: Curate Alternate Names and Definitions Overview of Alternate Question Text Question Text is how the question appears on a Case Report Form (CRF) or other Data Collection Instrument (DCI) Curators have the ability to add Alternate Question Texts so that the same CDE may be used on different forms. Alternate Question Text permits the re-use of semantically equivalent CDEs Example Data Element: Patient Date of Birth Form A Question Text: Pt DOB Form B Question Text: Date of Birth Form C Question Text: Patient Birth Date Form D Question Text: DOB Form E Question Text: … These are all semantically equivalent.

86. Lesson 6: Curate Alternate Names and Definitions Create Alternate Question Text Alternate Question Text is done in the Curation Tool Data Element Attributes related to Question Text: Pick the Reference Document Type: Alternate Question Text Enter Document Name: label for the question Document Text: this is the actual Alternate Question Text Optional: Enter a reference URL Add Selection Curation Tool – Designations

87. Lesson 6: Curate Alternate Names and Definitions Viewing Alternate Question Text Alternate Question Texts appear on the “Usage” tab of the Data Element Details screen in the CDE Browser. This Data Element is used on multiple forms, with multiple Alternate Question Texts. CDE Browser – Data Element Details Screen – Usage Tab

88. Lesson 6 Review Which of the following Administered Items can have Alternate Names? Data Element Data Element Concept Value Domain True or False: You should designate a Data Element for which you are adding Alternate Definitions. True or False: System Generated Definitions must be stored in the caDSR as the preferred OR alternate definition Why Create Alternate Question Text?

89. Lesson 6 Answers Which of the following Administered Items can have Alternate Names? Data Element Data Element Concept Value Domain True or False: You should designate a Data Element for which you are adding Alternate Definitions. TRUE True or False: System Generated Definitions must be stored in the caDSR as the preferred OR alternate definition. TRUE Why Create Alternate Question Text? For use on Forms, or so a DE matches they way in which it is being referred at your organization/institution All of them

90. 1061 Course Recap Now that you have completed this course you should be able to: Define a Data Element Describe how Data Elements are formed Identify the metadata standard used to guide metadata curation Describe how metadata is organized in the metadata repository Discuss how to decompose a question on a Case Report Form (CRF) or Data Collection Instrument (DCI) into a Data Element Access caDSR tools online to: Search for data elements that match questions on forms Evaluate candidates for re-use Search for data elements by their components Designate Data Elements for re-use in your Context Curate Alternate Names and Definitions of Administered items to reflect your needs

91. Training Evaluation Evaluate online! http://ncicb.nci.nih.gov/NCICB/training/cadsr_training/EvaluationForm

92. Training User Accounts – on Sandbox Server CDE Browser: http://cdebrowser-sandbox.nci.nih.gov/ CDE Curation Tool: htttp://cdecurate-sandbox.nci.nih.gov/ Sentinel Tool: http://cadsrsentinel-sandbox.nci.nih.gov Admin Tool: http://cadsradmin-sandbox.nci.nih.gov/ User ID / Password: Trainee01 / Trainee01 Trainee02 / Trainee02 … Trainee09 / Trainee09 Trainee10 / Trainee10

93. Contact Information Instructor: Jennifer Brush and Jamie Keller ( jbrush@scenpro.com) jbrush@scenpro.com (jkeller@scenpro.com)jkeller@scenpro.com NCI CBIIT Liaison: Dianne Reeves (reevesd@mail.nih.gov)reevesd@mail.nih.gov NCI CBIIT Application Support ncicb@pop.nci.nih.gov caDSR Home Page http://ncicb.nci.nih.gov/NCICB/infrastructure/cacore_overview/cadsr caCORE Training Home Page http://ncicb.nci.nih.gov/NCICB/training/cadsr_training caCORE Training Wiki https://wiki.nci.nih.gov/x/OAFy