myCSG © |Area: SDTM| Concept: TE : Trial Elements | Lesson: LCSG801 : TE domain for an example study CSG801 - parallel, 3 arms |

 

Background
  • The entire duration of expected participation in a clinical trial can be split into several distinct periods of time
  • These distinct periods of time are called 'elements'
  • An element may involve 'treatment' or 'no treatment'
    • 'Treatment' elements involve treating the subjects with one of the study drugs - investigational drug or matching control - active control or placebo
    • 'No treatment' elements include
      • preparing a subject for treatment - screening
      • washing out of any prior treatments - washout
      • observation period post treatment - follow-up
  • A subject's journey in the trial can thus be described as a combination of these elements
  • SDTM standard has a dataset named 'Trial Elements', which is used to describe all the possible 'elements' within a study
  • The expected record structure for TE domain is 'One record per planned Element

What type of information is typically collected or presented?
  • Study identifier
  • Domain name
  • Element code
  • Description of the element
  • Rule for Start of Element
  • Rule for End of Element 
  • Planned duration of the element
 

Study design schema
  • 4 weeks of screening
  • 12 weeks of treatment
    • CSG801 300 mg every two weeks
    • CSG801 600 mg every two weeks
    • Placebo every two weeks
  • 3 Weeks of follow-up

 
 
VARIABLE_NAMEVARIABLE_LABELDERIVATION
General General notes There will be no formal specification for Trial design domains.
We need to create it based on the protocol.
See the lesson description for the study design.
Complete SAS code to generate the output is available for registered users!

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