Audit Trail

What is an Audit Trail ?


An audit trail is a history of an event - it is a record of the creation and all the changes made to that record. A audit trail export is the ability to be able to extract the details of the changes that have been made. In the case of a result record, an audit trail should display the original result as well as the changed results. LabDriver has the ability to produce many audit trails, including that of a lab user (eg when they logged in and entered results), the creation of a clinical trial study (who and when it was created) and audit trails of individual lab or sample numbers.

 

Why are Audit Trails important ?


An audit trail should show the entire history of a sample, from the time that a sample is received and booked in, the details of the test results and the source of the results (which analyser produced the result, if it was manually typed in etc) right through to the details of who printed the lab reports and which printer the lab reports were printed to. The audit trail should show the changes that have been made to the results and display a record (using an electronic signature such as the Esig and Qsig) of who made those changes and when those changes where made. 

Can you show me a sample of an Audit Trail?

 

A sample audit trail from a single laboratory no is shown below.  There are different levels of audit trail depending on the category of the user. The audit trail below is the most detailed version and is produced for a "SuperUser" category of user.



Audit Trail Sample

Details of the contents of an Audit Trail
 

The audit trail of a lab no is divided into sections and the details of what is recorded is shown below

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Sample details:=
sample details, date and time sample was take and where it was stored 
 

Subject details:=
The subject details - sex, age, group.
In the Clinical Trials system the Study, Investigator and Timepoint will be recorded
 

Sample Changes Log:=
Results that have been imported from analysers and who imported them
This information also appears in test section against the test

 

Study Report Printing:=
Report name file. When and where were the study reports were printed
 

Profiles:=
Sample type, First test date and the ESig

 

Profile Changes Log:= 
Record of changes made in the profiles
 

Tests:=
Test name, Result (character or numeric),  Flag and Test status

 

Test Changes Log:=
Record of who made changes to the test result and when the changes were made

 

Tests Not Requested:=
Details of the test sent by the analyser but which were not requested (most analysers send the results of all tests performed).

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