The Subject Audit Report (3.2) allows a user to view and filter all changes made to Subject Records that occur within the Clinical Studio system.  To view the Subject Audit Report, hover your mouse over the Report Menu and click the “Subject Audit Report…(3.2)” link as shown in the figure below.


 


The Subject Audit Report has sections and usefulness displayed in the following figure:

  1. Choose Variables To Filter Report form.  The Choose Variables To Filter Report section allows a user to define the information that will displayed in the Audit Log data table. To filter the data table display, select the desired filter drop-downs and select the desired filter. AS each filter is selected the Audit Log quickly changes the displayed information. Individual filters or multiple filters can be selected to narrow the information the Audit Log data table displays.
  2. The Audit Log Table
  3. Select number in Transactions column highlighted to open up that forms transaction history as shown below:  Notice the text highlighted in Record detail table that shows which subject's information you are reviewing.
  4. The Audit Log data table contains a Rows Pagination drop-down like all the tables in Clinical Studio.  The changes column has a link called Field Value Changes if the data has been changed.  Click on that link to open up table for details.  Across the top of the table are descriptive header columns as shown in the figure below.  Each column is sort-able, in ascending and descending order, by clicking the header. To reverse the sort order, click the header again. Sort-able columns are defined by hovering your mouse  over the header column.  If the mouse pointer changes to a hand with the finger pointing up the column is sort-able.
  5. The Field Value Changes link open up the Field Changes table where you can see Old Value vs New Value and Reason for data change.
  6. Field Changes table displays old and new value along with Reason for Change from the field audit that is answered when data is changed in eCRFs by data entry personnel.
  7. Export Audit to Excel is displayed on the right side of the page and will export a table of all data changes for the data currently displayed in the Audit Log table. It is usually best to first filter at least by site to make the exported data more manageable. Once exported to Excel, further filtering, sorting, and reporting can be performed.

 

There are filters available to define the Audit Log data table display.  Below is a description of each filter.


  • Site – The Site drop-down list is populated with the sites that have been entered for the current sponsor. The filter allows the user to select either All Sites or an individual Site for the active Sponsor and Study that will be displayed in the Audit Log data table.
  • Subject – The Subject drop-down list is populated with all Subjects that have been registered in the current study. The filter allows the user to select either All Subjects or filter by a specific Subject ID for the active Sponsor, Study and Site.
  • Form - The Form drop-down list is populated by all the forms associated with Study. The filter allows the user to display either All Forms or an Individual Form for the the Active Sponsor, Study and Site(s).
  • Field - The field drop-down list will contain only "All Fields" if no specific form has been selected in the Form drop-down filter. However, if a specific form is selected from the Form filter drop-down list, the Field drop-down is populated with the list of fields that appear in the selected form. The filter allows the user to display either All Field changes or changes to the specific field within the form for the Active Sponsor, Study and Site(s).
  • Low Date – The Low Date field allows the user to define a specified low date for the Audit Log data table display. In other words, any date that precedes the date entered in the Low Date field would not be displayed in the Audit Log data table. The "Go" button must be clicked to enforce the filter. To clear the Low Date filter field, click in the field and click the delete button; tab through each section of the field and click the delete button until all fields are empty. Then select the "Go" button again to reset the filter.
  • High Date - The High Date field allows the user to define a specified high date for the Audit Log data table display. In other words, any date that falls after the date entered in the High Date field would not be displayed in the Audit Log data table. The "Go" button must be clicked to enforce the filter. To clear the High Date filter field, click in the field and click the delete button; tab through each section of the field and click the delete button until all fields are empty. Then select the "Go" button again to reset the filter.


Setting the Low and High Date Filters together allows the user to define a range of dates to display in the Audit Log data table.


The Subject Audit Report is an extremely useful and valuable report and is required by 21 CFR Part 11.