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Items: Item Counts by Property

Items: Item Counts by Property report elements let you report item totals based on their design characteristics.

Note: All item counts include only items that have at one time contained clinical data. These counts do not include items for which clinical data has never been entered.

Items: Item Counts by Property report elements

Report element

Description

Required

Data type: Y/N

Description: Indicates whether the item is required.

  • Y—A value must be entered for the item.
  • N—Data entry is not required for the item.

Data source: Derived and stored in the Reporting and Analysis database.

SV Required

Data type: Numeric

Description: The total number of items that require source verification and have ever contained clinical data.

How calculated: Counts items that:

  • Are marked SV Required.
  • Contain (or have ever contained) clinical data.

Data source: Derived and stored in the Reporting and Analysis database.

Calculated

Data type: Numeric

Description: The total number of calculated items, as specified in the study design code.

How calculated: Counts items that:

  • Have the item property set as a calculated control.
  • Have ever contained clinical data.

Data source: Derived and stored in the Reporting and Analysis database.

Blank

Data type: String

How calculated:

  • For a Repeating Data itemset, counts the number of blank items in the itemset.
  • For an item, indicates whether the item is blank, as designed in the study.
    • 0—Item is not in a Repeating Data itemset, or is in a Repeating Data itemset, but is not blank.
    • 1—Item is in a Repeating Data itemset, and is blank.

      Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

SV Selected

Data type: Numeric

How calculated: Counts items that have been selected for source verification.

An item has been selected for source verification if one of the following is true:

  • The item is marked SV Required and SV Critical.
  • The form on which the item exists is on the Critical Forms list.
  • The subject with which the item is associated is part of the SV Pool.
  • The subject with which the item is associated is not part of the SV Pool, but the item is marked critical for that subject.

    Data source: Replicated from the InForm transactional database to the Reporting and Analysis database and decoded for display.

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