A question can be set up by the study designer to request a Reason For Change (RFC) whenever a data entry user changes a saved question response. If this happens, a message is displayed asking the user to either select the RFC from a list, or enter an RFC of their own. The RFC selected or entered during data entry is displayed in the question audit trail along with the new question value.
For a question that needs an RFC, the RFC will be requested whenever a user changes a response value or status from a previously saved non-blank value (this includes overruling saved warnings). If a question has never previously had a non-blank value, or has never been set to Not Available, an RFC will not be requested.
The list of predefined RFCs is managed by the study designer on the Study Details screen.
RFCs are enabled for individual questions on the Question Attributes screen.
If a question's value or status is automatically changed by MACRO in any of the following ways, an automatic RFC will be stored with the response in the question audit trail:
An eForm is revalidated when it is re-opened
Values are entered causing "Collect if" conditions to change
Values are entered causing derived values to change
A new group row is generated
An eForm's status is changed between Missing and Not Available from the schedule
An eForm laboratory is changed
A subject is revalidated
A response value's status is changed via the API
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Automatic RFC |
Description |
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*** Response field enabled |
The question's "Only Collect if" condition has become true |
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*** Response deleted and disabled |
The question's "Only Collect if" condition has become false |
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*** Derived value recalculated |
A derived value has been recalculated |
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*** Status changed |
The question status has changed, for example a new warning may have fired due to changed data elsewhere, or a change to validation conditions in the study definition. |
|
*** Response value changed without a corresponding reason for change recorded |
A question value has been changed without entering a RFC. This should never happen, but is a known issue which has not yet been resolved by InferMed. An automatic RFC is stored to record that this has happened unexpectedly. |
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*** Value rejected |
The question value has been rejected, usually due to changed data elsewhere or to a change to validation conditions in the study definition |
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*** NR Status, CTC Grade or Lab changed |
A laboratory question's Normal Range status has changed, usually due to a change of laboratory or a change to the existing laboratory definition |
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*** Status changed by an external application using the API |
A response value's status is changed via the API |
Each automatic RFC contains one of the following contexts, to indicate why the change occurred:
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Context text |
Description |
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as a result of adding a group row |
A new group row has been automatically created on the eForm |
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as a result of changing eForm laboratory |
Lab definition associated with an eForm has been changed |
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after change to question |
Change caused by change to a different question |
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on reopening eForm |
Previously saved eForm is reopened and revalidated |
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after reloading subject data |
Another user has changed data elsewhere in this subject and data has been reloaded |
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as a result of revalidation |
eForm has been revalidated before saving, or has been processed as part of Batch Validation |
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as a result of changing eForm status |
eForm status has been changed from the schedule, e.g. set to Not Available |
When a question has had more than one response saved, the relevant 'Change to Response Data' icon will be displayed on the eForm next to the standard question status. These icons indicate whether the response has changed once, twice or three or more times.