Items: Item Counts by Property

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.