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changes.mady.by.user Christine Connolly

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changes.mady.by.user Lou Ann Kramer

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Metadataspec
NumDatasetDescriptionUse Case(s)
1Trial Arms (TA)

Represents each planned arm in the study including the sequences of elements in each epoch for each arm. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.

  • Nonclinical
  • Product Impact on Individual Health
2

Trial Elements (TE) 

Represents the elements used in the study including unique codes for each element, element descriptions, and the rules for starting and ending an element. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.

  • Nonclinical
  • Product Impact on Individual Health
3Trial Visits (TV)Represents the planned order and number of visits in the study within each arm 
  • Product Impact on Individual Health
4Trial Inclusion/Exclusion (TI)

Represents the inclusion and exclusion criteria for the study


  • Product Impact on Individual Health
5Trial Summary (TS)

Represents key summary characteristics for the study

  • Nonclinical
  • Product Impact on Individual Health
6Trial Sets (TX)

Represents planned sets of subjects (e.g., in vivo studies) and/or sources of information (e.g., in vitro studies) that result from combinations of experimental factors defined for the study 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-494

  • Nonclinical

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