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.
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.