Operational Audit Report

The system maintains audit records in accordance with what has been established by the FDA in the “Guidelines used for Clinical Trials”. This information allows the authorized users to permanently control the actions executed in the system.

For those audited actions, the system saves:

•“Activity”: This field indicates the operation performed, or refers to the Pre- Confirmed/Confirmed Site or Product.

•“Who”: This field indicates the person who performed the Activity.

•“When - Date”: It is the date in which the Activity was performed.

•“When - Time”: It is the time in which the Activity was performed.

•“Comment”: It is a free text that describes the comments entered by the user when the Activity is performed.

Time and date is server time - given time zone belongs to the user.

The system keeps the audit record of the operations:

•Reception

•Despatch

•Return

•Re-labelling

•Warehouse movement

•Destruction

Once an authorized user verifies and/or confirms each operation.

The system also keeps the audit record when the application executes:

•Modify Subproject - Products and Sites

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Through the menu: Projects, Operational Management Reports submenu, the system allows obtaining the audit information through the Operational Audit option.

Users with Administrator profile will have access to the functionalities to generate and export the “Operational Audit” report.

By clicking the “Operational Audit” option, the system will display the following screen:

When the user does not know the Subproject Code of the audit report, he/she can search it by clicking the “…” button, which will display a screen where the user will be

able to search the subproject by means of different filters.

By clicking the Search button; the system will display a list of existing subprojects indicating Subproject Code, Type, Sponsor Name, Project Code, Protocol, Status.

The system arranges the result of the search in pages that may contain and display up to 10 Projects. In the lower part of the screen the user will be able to select the page

with the desired result.

If there are no subprojects, it will display a blank screen.

The system allows searches filtering by Subproject Type: the type will be selected from the drop down list in the screen: IP, CTM, CMP.

Filtering by Subproject Status: the status will be selected from the drop down list on the screen: Start Up, Active, Closed.

Besides, the user can filter by: Sponsor, Project Code and Protocol.

If the user needs to make a new search, he/she can reset the screen by clicking the Reset button.

By selecting a Subproject from the list; the system will go back to the previous screen automatically.

Once the Subproject Code of the audit report has been entered, the system will automatically fill the fields: Sponsor, Protocol, Subproject Type.

The system allows filtering by user: a user has to be selected from the drop down list on the screen. IN this case, the audit report will contain the activities performed by a

particular user of the selected subproject.

Filtering by Activity/Operation: an activity or operation will be selected from a drop down list on the screen. In this case, the audit report will be produced for a particular

activity/operation of a selected subproject.

The user will be able to filter by “Date From” and “Date To”, in such case the audit report will be produced with the information comprised within the range of the dates entered.

If a range of date is not entered, the system will produce a complete audit report of the selected subproject. It is important to mention that the 'Date To' cannot be

later than the present date.

Once the Subproject Code and filters to be applied have been selected, the user will click on Export to .XLS to generate a report, the system will open the report in a

Microsoft Office excel file, then the user will be able to print this file or save it in the computer.

The Audit Report has the following columns:

•Protocol

•SubProject

•Activity

•Detail

•Preconfirmation User

•Preconfirmation Date and Time

•Preconfirmation Time Zone

•Confirmation User

•Confirmation Date and Time

•Confirmation Time Zone

•Confirmation Comments

Date and Time refers to server time - the given time zone belongs to the user who performed Preconfirmation or Confirmation.