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Forms: Form Status Counts

Forms: Form Status Counts report elements return totals of forms according to their status.

Forms: Form Status Counts report elements

Report element

Description

Form Count

Data type: Numeric

Description: The total number of forms.

How calculated: This calculation includes all forms, including expected forms, forms that have not been started, and unscheduled forms. Use this report element in combination with other predefined filters to narrow report results.

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

Expected

Data type: Numeric

Description: The number of expected forms in the study.

How calculated: Counts forms that meet any of the following criteria:

  • Appear within a scheduled visit (regardless of whether the form is started).
  • Appear within a started unscheduled visit.
  • Are activated dynamic forms.

    Counts expected forms only for subjects who have been enrolled in the InForm application (includes enrolled, randomized, completed, and dropped subjects).

For subjects that have completed or dropped (as indicated by the Study Completion form), only forms in started visits or dynamic started forms are counted. Non-started common forms are not counted as expected.

 

Only CRFs are counted. Other special CRFs (such as screening and enrollment) are not included.

  • Alternate forms—One form in each visit is counted.
  • Common forms—A common form is counted only once for the study, regardless of the number of visits in which it occurs.
    • For enrolled or randomized subjects, common forms are considered expected.
    • For complete or dropped-out subjects, only started common forms are considered expected.
  • Common dynamic forms—Each activated or started instance is counted one time.
  • Common dynamic repeating forms—Each activated or started instance is counted one time.
  • Common repeating forms—Each instance is counted one time.
  • Dynamic forms—One activated dynamic form is counted for each visit in which it exists. Deleted (removed) form instances are not counted as expected.
  • Dynamic repeating forms—Each activated or started instance is counted one time.
  • Regular forms—One form is counted for each visit.
  • Repeating forms—For repeating forms that have not been started, one instance of the form is counted as expected. For repeating forms that have been started, each started instance counts as expected. Deleted (removed) form instances are not counted as expected.

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

Started

Data type: Numeric

Description: Total count of all forms that are started across all subjects, by visit and by site.

How calculated: An expected form is considered started if any type of data entry activity (form data, queries, or comments) has started on the form.

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

Note: To report on forms that are started but incomplete, subtract the complete count (Complete report element) from the started count (Started report element).

Missing Required Items

Data type: Numeric

Description: The number of started forms for which at least one required item is empty.

How calculated: Counts forms that:

  • Are started.
  • Contain required items.
  • Have at least one required item that does not contain data.

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

Complete

Data type: Numeric

Description: Total count of all forms that are complete across all subjects, by visit and by site.

How calculated: An expected form is considered complete if all of the required items for the form are supplied. For repeating forms, the form cannot be in a deleted state.

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

Frozen

Data type: Numeric

Description: The number of expected forms that are currently marked Frozen.

How calculated: Counts forms that are expected and have been frozen using any of the following InForm features:

  • Freeze CRF
  • Freeze CRB
  • Freeze Visit

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

SV Ready

Data type: Numeric

Description: The number of forms that are currently marked SV Ready.

How calculated: Counts forms that are marked SV Ready, and are 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.

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

SV Partial

Data type: Numeric

Description: The number of forms that are currently marked SV Partial.

How calculated: Counts forms that are in the SV Partial state.

A form is considered SV Partial if one of the following is true:

  • The form contains unverified critical items.
  • The form is on the Critical Forms list, and contains unverified items that are marked SV Required.
  • The subject with which the form is associated is in the SV Pool, and the form contains unverified items that are marked SV Required.
  • 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 the form contains unverified items that are marked SV Required.

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

SV Complete

Data type: Numeric

Description: The number of verified forms.

How calculated: Counts forms that are marked Verified.

A form is considered Verified if the form is selected for source verification, and 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.

    Note: For more information on source verification, see the User Guide for Sponsor Users.

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

Signed

Data type: Numeric

Description: The number of signed forms and the percentage of expected forms that are currently signed in the InForm application.

How calculated: Counts forms that have been signed by all groups that are required to sign the form. This value appears as a whole number and as a percentage of expected forms that are signed:

[signed, % of expected] = [signed forms count] * 100 / [expected forms count]

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

Locked

Data type: Numeric

Description: The number of locked forms.

How calculated: Counts forms that:

  • Have been locked in the InForm application at the form level or visit level.
  • Are contained within a case book that has been locked in the InForm application.

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

Marked Incomplete

Data type: Numeric

Description: The number of forms that have been marked Incomplete.

How calculated: Counts forms that have an existing form comment(s) with an Incomplete Reason of Not Done, Not Applicable, or Unknown.

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

Has Data

Data type: Numeric

Description: The number of forms on which some data has been entered.

How calculated: Counts forms that have entered data in at least one item. The item with data does not need to be a required item.

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

Has Open Query

Data type: Numeric

Description: The number of forms with open queries.

How calculated: Counts forms that contain items with open queries. This count does not include forms that contain items with queries in states other than Open.

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

Has Answered Query

Data type: Numeric

Description: The number of forms with answered queries.

How calculated: Counts forms that contain items with open queries. This count does not include forms that contain items with queries in states other than Answered.

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

Candidate Query

Data type: Numeric

Description: The number of candidate queries. Use with the Form Name report element to see the number of candidate queries that are associated with a particular form.

How calculated: A query is counted if it is currently a candidate query.

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

Open Query

Data type: Numeric

Description: The number of open queries. Use with the Form Name report element to see the number of open queries that are associated with a particular form.

How calculated: A query is counted if it is currently open. This count includes reissued queries.

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

Answered Query

Data type: Numeric

Description: The number of answered queries. Use with the Form Name report element to see the number of answered queries that are associated with a particular form.

How calculated: A query is counted if it is currently answered.

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

Has Form Comment

Data type: Numeric

Description: The number of forms that contain form-level comments.

How calculated: Counts forms that contain at least one form-level comment. This calculation includes forms that have been marked Incomplete. This count does not include forms with only item-level comments.

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

Has Item Comment

Data type: Numeric

Description: The number of forms that contain items with item-level comments.

How calculated: Counts forms that contain at least one item-level comment. This calculation includes items that have been marked Incomplete. This calculation does not include forms that include only form-level comments.

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

Deleted Repeating

Data type: Numeric

Description: The number of repeating forms that have been deleted.

How calculated: Counts forms that are repeating forms that have been deleted.

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

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