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CRF Item Listing

This report shows a list of form items that are in a given state or that entered a given state as of a specified point in time. The report is organized by site, subject, visit, and form. You can filter for missing items or for items that were changed after a given time.

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Column descriptions

Column descriptions

Column

Description

Site

Data type: String

Description: An abbreviation that identifies a site, as entered in the InForm Administration interface.

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

Subject Number/Initials

Data type: String

Description: The subject number, followed by the subject initials.

The subject number identifies the subject. The subject number and subject initials can be changed post enrollment, if this is configured in the study.

Note: Subject number might not be unique at your site.

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

DOV

Data type: Date/Time

Description: The date that is recorded in a standard Date of Visit control in the 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 InForm application.

To open the form in InForm, log in to InForm if prompted, then click the link in this column.

Data source: Replicated from the 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.

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

Form State Dates: SV Ready

Data type: Date/Time

Description: The most recent date on which the status of the form was set to SV Ready.

A form is considered SV Ready if it has a status of SV Ready, and is selected for source verification.

A form has been selected for source verification if one of the following is true:

  • The form contains one or more critical items.
  • The form is on the Critical Forms list.
  • The subject with which the form is associated is in the SV Pool.
  • The subject with which the form is associated is not in the SV Pool, but an item on the form is marked critical for that subject.

Date type: System date (GMT).

Form State Dates: Frozen

Data type: Date/Time

Description: The most recent date on which the status of the form was set to Frozen in the InForm application. Note that a value displays here only if the form has a current status of Frozen.

Date type: System date (GMT).

Form State Dates: SV Complete

Data type: Date/Time

Description: The most recent date on which the form was marked Verified.

A form is considered Verified if one of the following is true:

  • The form does not contain critical items, and all items on the form that are marked SV Required are verified.
  • The form contains critical items, and all critical items on the form are verified.
  • The form is on the Critical Forms list, and all items on the form that are marked SV Required are verified.
  • The subject with which the form is associated is in the SV Pool, and all items marked SV Required are verified.
  • The subject with which the form is associated is not in the SV Pool, but an item on the form is marked critical for that subject, and all items marked SV Required are verified.

    If none of the items on the form require source verification, the InForm application marks the form Verified.

Date type: System date (GMT).

Form State Dates: Signed

Data type: Date/Time

Description: The most recent date on which the form was signed in the InForm application. Note that a value displays here only if the form has a current status of Signed.

Date type: System date (GMT).

Form State Dates: Locked

Data type: Date/Time

Description: The most recent date on which the form was locked in the InForm application. Note that a value displays here only if the form has a current status of Locked.

Date type: System date (GMT).

Item Properties: Required

Data type: Y/N

Description: Indicates whether the item requires a value for the form to be considered data entry complete. Valid values are:

  • Y—The item is required.
  • N—The item is not required.

Note: Itemset items cannot be required.

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

Item Properties: 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 InForm transactional database to the Reporting and Analysis database and decoded for display.

Item Properties: SV Required

Data type: Y/N

Description: Indicates whether the item requires source verification.

  • Y—The item requires InForm source verification.
  • N—The item does not require source verification.

An item is considered SV Required only if it is marked SV Required.

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

Item Properties: 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 InForm transactional database to the Reporting and Analysis database and decoded for display.

Item Properties: Has Query

Data type: Y/N

Description: Indicates whether the item has an open query associated with it.

  • Y—The item has an open query.
  • N—The item has no open queries.

Note: This field is not supported in itemsets.

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

Item Properties: Has Comment

Data type: Y/N

Description: Indicates whether the item has a comment associated with it.

  • Y—The item has a comment.
  • N—The item does not have a comment.

Note: This field is not supported in itemsets.

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

Item Properties: Data Modified

Data type: Date

Description: The date on which data was most recently modified.

Date type: System date (GMT).

Item Properties: Original Value Date

Data type: Date

Description: The date on which data was originally entered into the item.

Date type: System date (GMT).

Item Properties: Data Change User

Data type: String

Description: The user name of the InForm user who made the most recent change to the item.

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

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