@namespace xforms url(http://www.w3.org/2002/xforms); xforms|upload[appearance='open'] { -moz-binding:url('xbl/FileSaveXBLStudyDesign.xml#open'); } xforms|upload[appearance='saveas'] { -moz-binding:url('xbl/FileSaveXBLStudyDesign.xml#saveas'); } /* Need to initialize() after *model* so we can find it via script */ initialize(); HL7 Study Data - Study Design XForm v1.0.0 `Copyright © 2010 U.S. Food and Drug Administration` Save Show Hints Hide Hints Study Details Experimental Units Yes View Grid Yes Copyright notice Study Details Describe the action plan for a formal investigation to assess the utility, impact, pharmacological, physiological, and psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. Protocol Identifier *: Identifies the study protocol. This ID is used to link the planned study to the performed protocols. Protocol Name *: A short name for the study protocol. Planned Study Title: A title for the study. Study Description: Detailed description for the Study being planned. Study Details No Experimental Units Yes View Grid Yes No Copyright notice Experimental Units The experimental unit is the physical entity which is the primary unit of interest in a study. In an interventional study, the experimental unit is assigned to an intervention. The experimental unit is also the unit of primary statistical analysis. Commonly the individual subject (animal, person or product) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions. Accordingly if all pigs in a pen receive the same intervention in their feed, and the primary observations and analyses of interest are associated with the entire pen (e.g. total feed consumed, total weight of all pigs combined), then the pen of pigs rather than the individual animal is the experimental unit. This means that the statistical analysis may be incorrect if it is assumed that the pig is the experimental unit. In this case the statistical analysis should normally be done using the mean of all the pigs in the pen. An example of when the expirmental unit is a product would be product stress test or product performance studies. Experimental units assigned below will apply to all existing 'Cells' in the Arm.
Arm Name
ID / Group ID
Quantity
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Condition Text
Value / Description
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Arm Name
Unit ID
Type/Kind
Quantity
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Condition Text
Value / Description
Delete Condition Add Condition Study Details No Experimental Units Yes No View Grid Yes Copyright notice Study Details No Experimental Units Yes No View Grid Yes No Copyright notice Copyright Notice Copyright (c) 2010 U.S. Food and Drug Administration

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