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The purpose of the SDTM Trial Design Model is to represent a brief, clear description of the overall plan and design of a nonclinical study or clinical trial. Guidance in this section is applicable to TIG Nonclinical and Product Impact on Individual Health use cases only. In this section, the term "trial" is equivalent to "study" in the nonclinical context. Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol.The TIG guides implementation of the Trial Design datasets described in the table below for use cases as indicated. Concepts  


Metadataspec
NumDatasetDescriptionUse Case(s)
1Trial Arms (TA)Represents the sequences of elements in each epoch for each arm, and thus describes the complete sequence of elements in each arm.
  • Nonclinical
  • Product Impact on Individual Health
2

Trial Elements (TE) 

Represents the elements used in the trial.
  • Nonclinical
  • Product Impact on Individual Health
3Trial Visits (TV)Represents the planned schedule of visits.
  • Product Impact on Individual Health
4Trial Inclusion/Exclusion (TI)Represents the criteria used to screen subjects.
  • Product Impact on Individual Health
5Trial Summary (TS)Represents Lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials
  • Nonclinical
  • Product Impact on Individual Health
6Trial Sets (TX)add text here
  • Nonclinical


Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol. Concepts specific to Trial Design datasets 






and recommended steps for working through the design of a trial are also provided in this section.





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