| Info |
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| title | Clinical Data Hierarchies |
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| Gliffy Diagram |
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| border | true |
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| size | 600 |
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| displayName | Simple view of EDC Data |
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| name | Simple view of EDC Data |
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| pagePin | 12 |
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| Gliffy Diagram |
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| size | 600 |
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| displayName | Simple view of Dataset data |
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| name | Simple view of Dataset data |
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| pagePin | 13 |
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For ODM v2.0, there are 2 forms of the clinical data hierarchy. The full subject data hierarchy (Figure 1) is typical of usage within data collection tools such as EDC systems. The dataset hierarchy (Figure 2) reflects data tabulation formats that are typical of usage for data review and submission. |
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A StudyOID uniquely identifies a study. A SubjectKey uniquely identifies a subject within a study. SubjectKeys are not intended to be used to identify a subject across studies.
| Jira |
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| server | Issue Tracker (JIRA) |
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| columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
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| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ODM-37 |
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| Jira |
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| server | Issue Tracker (JIRA) |
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| columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
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| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | ODM-41A StudyEventOID uniquely identifies a StudyEventDef within a study. However, there may be several study events of a particular type for a given subject. The StudyOID, the SubjectKey, the StudyEventOID, and a StudyEventRepeatKey are all needed to fully identify a particular study event.
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