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- Section 3.1.3 The Findings Observation Class
- --CELLEV, Number of Cells Evaluated
- Section 3.1.4, Identifiers for All Classes
- GNTXAID
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | SDTM-805 |
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, Genetic Toxicology Assay Identifier
- SPTOBID, Applicant-defined Tobacco Product Identifier
- IGDCMPID, Ingredient or Component Identifier
- STOCONID, Applicant-defined Storage Conditions ID
- Section 5.1.2 Trial Sets
- GNTXAID, Genetic Toxicology Assay Identifier
- Section 5.1.6 Trial Summary Information
- GNTXAID, Genetic Toxicology Assay Identifier
Some new variables
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | SDTM-770 |
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have been added to sections,| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | SDTM-771 |
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as noted in the New Variable column in the Variables table.Many variable labels, notes, definitions, or examples were modified. In most cases, these modifications were to use the phrase "treatment or product" for the case when product use is not considered a treatment.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | SDTM-781 |
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In some cases a definition was added where there was none before.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | SDTM-780 |
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The type and location of revisions made are described in the following tables.
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