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Description

ConfiForms ValueView
filtername:TX AND implementation:non
fieldNamedescription
pageTitleContent Control for SDTM-based datasets
formNamedatasetMetadata

ConfiForms ListView
filtername:TX
cssfont-weight:bold;
fieldNamelocation
pageTitleContent Control for SDTM-based datasets
formNamedatasetMetadata
name.lowerCase.xpt, label — parentClass. structure, Tabulation.


Specification

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titleDomain Specification Table

Include Page
SEND TX specification
SEND TX specification


Assumptions

Include Page
SEND TX assumptions
SEND TX assumptions

Pagenav

...

  • A Trial Set is a planned set of one or more subjects, possessing experimental factors, treatment factors, or sponsor-defined attributes that differentiate the set from other Trial Sets on the same trial.
  • Any subject that is selected for the study will be in one and only one Trial Set (i.e., Trial Sets are mutually exclusive and do not overlap).
  • The Trial Set is associated with a single Trial Arm (the set of subjects assigned to a treatment strategy). More than one Trial Set may be associated with the same Arm; however, any Trial Set should be associated with only one Arm only. If a Trial Set appears to be associated with multiple Trial Arms, then it should be further subdivided into Trial Sets, each of which is associated with one Arm through the use of treatment strategy as an experimental factor.

Anchor_Toc290965774_Toc290965774 Anchor_Toc454959268_Toc454959268 Trial Sets – TX
tx.xpt, Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set, Tabulation.
{include:TX specification}
Anchor_Toc279493931_Toc279493931 Anchor_Toc290965775_Toc290965775 Anchor_Toc454959269_Toc454959269Assumptions for Trial Sets (TX) Domain Model
{include:TX assumptions}