Study Definition module

 

Status and information icons for study designers

The following icons are used throughout the MACRO Data Entry and Data Review modules to indicate the status of and give information about data entered for individual questions, eForms, visits and subjects.

Question Status

Invalid

This icon is only displayed within a validation message and never on an eForm. It indicates that the value entered for a question has satisfied a 'Reject If' validation condition, and the value is not being accepted.

 

Not Applicable

This icon indicates that this question, or a question within this eForm or visit cannot be answered as there are skip conditions assigned that have been satisfied. For example, if previous answers have identified the subject as male, any questions about pregnancy would automatically be made Not Applicable.

 

 

OK

This icon indicates that this question, or all questions within this eForm, visit or subject have been successfully answered and have not fired any attached validation conditions. The 'OK' status may be applied to an unanswered question if this question has been marked as 'optional' by the study designer.

 

OK Warning

This icon indicates that the data entered for this question or at least one question within this eForm, visit or subject has satisfied a 'Warn if' validation condition and that this warning has been overruled by the user.

 

Missing

This icon indicates that this question, or at least one question within this eForm, visit or subject has not yet been answered or if an eForm within this visit has not been opened. It is possible to manually toggle the status of Missing and Not Available. How to change between statuses

 

Not Available

This icon indicates that this question, or a question within this eForm, visit or subject has had its status manually changed from 'Missing' to 'Not Available', to show that it is not possible to obtain an answer for the question.

How to change between statuses

Warning

This icon indicates that the data entered for this question or at least one question within this eForm, visit or subject has satisfied a 'Warn if' validation condition.

 

 

Inform

This icon indicates that the data entered for this question has satisfied an 'Inform if' validation condition. This icon only appears to users with the 'Monitor/review data' permission. The 'Inform' status can only apply to a question and not to an eForm, visit or subject.

Normal Range

These icons appear in addition to the main question status icon.

High

This icon indicates that the value entered is above the normal range but within the absolute range. It has been accepted.

Normal

This icon indicates that the value entered is within the normal range. It has been accepted.

Low

This icon indicates that the value entered is below the normal range but within the absolute range. It has been accepted.

Notes and Comments

These icons appear in addition to the main question status icon.

Note

This icon indicates that this question has a note attached to it. This icon can only apply to a question and not to an eForm, visit or subject.

Comment

This icon indicates that this question has a comment attached to it. This icon can only apply to a question and not to an eForm, visit or subject.

Note and Comment

This icon indicates that this question has a note and a comment attached. This icon can only apply to a question and not to an eForm, visit or subject.

DCR

These icons appear in addition to the main question status icon. Note that there is no icon for a DCR with the status of Received.

Raised

This icon indicates that this question, or a question within this eForm, visit or subject has a raised DCR against it.

Responded

This icon indicates that this question, or a question within this eForm, visit or subject has a responded DCR against it. Data reviewers make like to use this icon as an indication of DCR response.

Closed

This icon indicates that this question, or a question within this eForm, visit or subject has a closed DCR attached to it.

SDV

These icons appear in addition to the main question status icon. Note that there is no icon for an SDV with the status of Cancelled.

Planned

This icon indicates that this question, or a question within this eForm, visit or subject has a planned SDV against it.

Queried

This icon indicates that this question, or a question within this eForm, visit or subject has a queried SDV against it.

Done

This icon indicates that this question, or a question within this eForm, visit or subject has a resolved SDV against it.

Changes to Data

These icons appear in addition to the main question status icon.

 

One

This icon indicates that the question has had one previous value saved to the database. The changed value can be viewed in the audit trail. This icon only appears at the question level, not eForm or visit level. Data reviewers may like to use the icon as an indication of change.

 

Two

This icon indicates that the question has had two previous values saved to the database. The changed values can be viewed in the audit trail. This icon only appears at the question level, not eForm or visit level. Data reviewers may like to use the icon as an indication of change.

 

Three +

This icon indicates that the question has had three or more previous values saved to the database. The changed values can be viewed in the audit trail. This icon only appears at the question level, not eForm or visit level. Data reviewers may like to use the icon as an indication of change.

CTC grade

These icons appear in addition to the main question status icon.

Grade 1

This icon indicates that the laboratory test result has a CTC grade of 1. This is the least abnormal.

Grade 2

This icon indicates that the laboratory test result has a CTC grade of 2.

Grade 3

This icon indicates that the laboratory test result has a CTC grade of 3.

Grade 4

This icon indicates that the laboratory test result has a CTC grade of 4. This is the most abnormal.

Freeze/Lock

Frozen

This icon indicates that data has been frozen at a question, eForm, visit or subject level. The frozen icon is displayed in the status column of the Data Browser, in the schedule and beside relevant questions in the eForm.

Frozen data cannot be changed although you can still create SDVs, DCRs and Notes.

Locked

This icon indicates that data has been locked at a question, eForm, visit or subject level. The locked icon is displayed in the status column of the Data Browser, in the schedule and beside relevant questions in the eForm.

Locked data cannot be changed although you can still create SDVs.

eForm only icons

 

Inactive eForm

This icon indicates that the eForm is inactive and usually means that you have to complete the eForms in a particular order specified by the study designer. The inactive eForm will become active when all the relevant eForms have been completed.

 

 

Blank eForm

This icon indicates that the eForm is active but has no data entered. The status of a blank eForm may sometimes be referred to as 'requested'.

 

Question status icon display

By default, question status icons are displayed on eForms during data entry but you can switch this off for individual questions if required using the Show Icons column within the eForm definition window. This can be particularly useful for questions within a question group to save space within the group layout.

You can change the defaults and choose to have this flag set automatically for new questions by selecting the Hide Icons and Hide Icons in RQGs options in the Options menu.

Icon display priority

A subject/visit/eForm/question group is likely to contain questions with differing statuses. In order to decide which icon is displayed at the higher level, the following priorities are used.

  1. Locked or Frozen

  2. DCR

  3. Warning

  4. OK Warning

  5. OK, Missing, Unobtainable, Not Available, Inform

For example, a locked eForm containing questions with DCRs will always be represented by the 'lock' icon as this has a higher priority than the DCR icon.

Hovering over an eForm/visit/subject in the schedule will display a tooltip showing all the statuses for that item.

Subject status

The status of a subject who has no data entered may sometimes be referred to as 'requested' although there is no icon for this.

A subject's status is only set to 'OK' if all visits are complete. If any visit contains a non-repeating eForm which is blank, the subject status will be 'Missing' even if all other eForms have status 'OK'.