myCSG © |Area: ADaM| Concept: C1007 : ADaM BDS - Visit Windowing | Lesson: L101 : Creation of visit windowing based on ADY and prespecified intervals - parameter invariant |

Background for visit windowing
  • In clinical trials, we collect certain data at planned intervals
  • The planned intervals are called 'visits'
  • Each planned visit will have a specific target day on which the collection has to be made in an ideal scenario
  • This 'planned day' is generally called as 'target day' for that visit
  • Sometimes, it is fine to collect the data around the target day by plus or minus a few prespecified number of days
  • That is, instead of a target day, the collection can be made in a 'target window'
  • Each window will have a target day, beginning timepoint, and an ending timepoint
  • Any collection made in the time window for a specific time point (visit) will be analyzed under that visit

ADaM implementation
  • CDISC ADaM standard allows for visit windowing
  • There are standard variables available to use when visit windowing is required
  • AWTARGET is used to capture the target day for the visit
  • AWLO is used to capture the allowed beginning timepoint for that visit
  • AWHI is used to capture the allowed ending timepoint for that visit
  • AWU is used to capture the visit window units (days, months, years etc)
VARIABLE_NAMEVARIABLE_LABELDERIVATION
AVISIT Analysis Visit Populate as 'Week 1' if 2<=ADY<=11
Populate as 'Week 2' if 12<=ADY<=18
Populate as 'Week 3' if 19<=ADY<=25
Populate as 'Week 4' if 26<=ADY<=32
Populate as 'Week 5' if 33<=ADY<=39
AVISITN Analysis Visit (N) Populate as 1 when AVISIT='Week 1'
Populate as 2 when AVISIT='Week 2'
Populate as 3 when AVISIT='Week 3'
Populate as 4 when AVISIT='Week 4'
Populate as 5 when AVISIT='Week 5'
AWTARGET Analysis Window Target Populate as 7 when AVISIT='Week 1'
Populate as 14 when AVISIT='Week 2'
Populate as 21 when AVISIT='Week 3'
Populate as 28 when AVISIT='Week 4'
Populate as 35 when AVISIT='Week 5'
AWLO Analysis Window Beginning Timepoint Populate as 2 when AVISIT='Week 1'
Populate as 12 when AVISIT='Week 2'
Populate as 19 when AVISIT='Week 3'
Populate as 26 when AVISIT='Week 4'
Populate as 33 when AVISIT='Week 5'
AWHI Analysis Window Ending Timepoint Populate as 11 when AVISIT='Week 1'
Populate as 18 when AVISIT='Week 2'
Populate as 25 when AVISIT='Week 3'
Populate as 32 when AVISIT='Week 4'
Populate as 39 when AVISIT='Week 5'
AWU Analysis Window Unit Set to 'Days'
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