Source Verification Listing

This report shows, for the specified date range:

• Form items for which the SV status changed.
• Form items for which data was entered (regardless of if a form status change or SV action is taken).
• Form items not source verified if other items on the same form were source verified in the specified date range:
  • This scenario is indicated in the report by an item row having a status of Verified = N and the Last Verified column being blank as the item has never been verified. The Status Change User column records the user that verified other items on the form.
  • This behaviour is observed inclusive of items with and without a value (blank), unless the item is part of an itemset, in which case blank items are not listed in the report.

CRAs use this report to compile a list of items to source verify when visiting a site, or to view those items that were source verified/un-source verified in a given time period.

Tip:

• You must select a visit and at least one form on the Selection Criteria page.
• If you use the Limit to filter on the Selection Criteria page, the report displays data items that have all of the selected criteria. For example, if you select Unverified Items and No Longer Verified Items, the report contains only forms that have both unverified and no longer verified items.

Table 3-13 Column descriptions

Column	Description
Site	Data type: String Description: An abbreviation that identifies a site, as entered in the Oracle InForm Administration interface. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Subject Number	Data type: String Description: The number that identifies the subject. This number can also be changed post-enrollment, if configured in the study. Note: Subject number might not be unique at your site. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Visit	Data type: String Description: An abbreviation of the visit title, as specified in the study design. For CRF visits, this title appears at the top of a collection of forms in the visit timeline and may not be a unique identifier. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
DOV	Data type: Date Description: The date that is recorded in a standard Date of Visit control in the Oracle InForm application. Data type: Clinical Note: This report element assumes that your study was developed using a specific design for the DOV controls. UUIDs: DateTimeControl—BD991BC0-B0A4-11D2-80E3-00A0C9AF7674 Item—BD991BBF-B0A4-11D2-80E3-00A0C9AF7674 Section—BD991BBE-B0A4-11D2-80E3-00A0C9AF7674
Form	Data type: String Description: A short name or abbreviation for the form, as specified in the study design code. Short name or abbreviation for the form, as specified in the study design code. This name appears on the Visit Navigation tab and is used to access a specific form in the Oracle InForm application. To open the form in Oracle InForm, log in to Oracle InForm if prompted, then click the link in this column. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Form Index	Data type: Numeric Description: For repeating forms, a numeric ordinal value that identifies an iteration of a form. For non-repeating forms, the value is 1. Data source: Derived for the report; not stored in the Reporting and Analysis database.
Item Question	Data type: String Description: Text of the question or prompt that instructs the user to enter specific clinical data. Access to this data can be restricted in the Oracle InForm application. When users who do not have access to this data run a report with this report element, the resulting report displays a series of asterisks (********) rather than the actual item question. Oracle InForm items that have never contained data will not appear on reports that pair Item Question with Form Name or Form Mnemonic. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Status Change User	Data type: String Description: The user name of the Oracle InForm user who made the most recent change to the status of the item. A change to the SV status of the item is considered a status change for the item. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Verified	Data type: Y/N Description: Indicates whether the item is source verified. Y—The item is source verified. N—The item is not source verified. An item is considered source verified if it is in the Verified state. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database and decoded for display.
Last Verified	Data type: Date Description: The most recent date on which the item was source verified. An item is considered source verified if it is in the Verified state. Date type: System date (GMT).
Data Change User	Data type: String Description: The user name of the Oracle InForm user who made the most recent change to the item. Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.
Data Last Modified	Data type: Date Description: The date on which data was most recently entered into the item. Date type: System date (GMT).
Is SV Selected	Data type: Y/N Description: Indicates whether the item has been selected for source verification. Y—The item has been selected for source verification. N—The item has not 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 Oracle InForm transactional database to the Reporting and Analysis database and decoded for display.
Source Verified Targeted	Data type: Y/N Description: Indicates whether the item has been source verified and selected for source verification. Y—The item has been source verified and selected for source verification. N—The item has not been source verified and 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 Oracle InForm transactional database to the Reporting and Analysis database and decoded for display.