Introduction
A series of frequently asked questions around audit trails and their interpretation.
How do I know if data was collected using a device?
Observation
Item audit stamps do not indicate source of data (e.g. device vs user). For example: An audit stamp of User: “Jane Doe” with Reason: “User Entry” appears to be used for both direct data entry and externally sourced data.
When inspecting Item Group Data on a form, it is easy to tell that data was designed, and intended to be collected, using a device interface. You will see a Device Profile listed...
This Device Profile is not present when there is no device interface for that data.
Under certain circumstances, the operator may need to over-ride the device integration and submit data manually…
Every time this occurs an unlocking Annotation is created, capturing the ‘unlock reason’ provided by the user.
The logged in user responsible for operating the equipment is recorded in the Audits...
In every case, it is always possible to determine whether an item was collected manually or by means of a device integration.
Response
What time is shown on a form when data is collected using a device?
Observation
For device uploaded data, the collection date/time shown in ClinSpark represents when the user performed the upload rather than the actual collection
Response
This is not strictly true and will vary from device to device.
Vital Signs - example
In the following example we see a Vital Signs device integration being used. The device itself does not pass the measurement time to ClinSpark. What is recorded is the time that the form is saved (at 1 and 2)…
It is therefore incumbent upon users to complete the procedure smoothly and quickly and to save the form as soon as the measurement has been captured and thus best representing the measurement time. With typical workflows it is expected that this should occur within seconds of the measurement being performed.
ECG - example
In another example we see a device integration where the device captures the measurement time and is capable of transferring this to ClinSpark.
The Collected times shown in (1) and (2) can be seen on the ’source’ ECG waveform by clicking View (3)…
Further Reading
You may find the following articles useful…
How do I know if data is a calculated or derived rather than entered by hand?
Observation
Non-user entries (e.g., Calculations, device, and imported data) appear to be stamped as user instead of systems
Response
With newer releases of ClinSpark calculations such as Methods are clearly flagged as such.
In this case the response to the question Are Vital Signs Out of Range? has been derived by a Method and determined to be No.
This is clearly shown here at item 1.
In addition, an Annotation (2) shows that the Item is a Calculated Entry.
As always, the logged in user responsible for triggering the Method is recorded in the Audits (3)…
In summary where you see Calculated Via Method or Calculated Entry this denotes that the value has been determined programmatically by the system.