Overview on Status View

Each object within the Trialex System has a status associated with it.  This is used for the purpose of tracking changes to the clinical data warehouse as data flows through it.  The objects which contain user defined status information include: the report, program and data objects.

Valid status values are defined by the administrator during configuration of the installation.  Some examples of valid status values include:

• Planned
• Draft
• Verification Started
• Verification Completed
• Compliance Audit Started
• Compliance Audit Completed
• Frozen

The goal of the status view is to give users the ability to view all the reports and the associated programs and data that are used to generate that report.  It also gives the project manager a tool to track and assign the proper status to each object.  During this review process, e-Notes can also be generated that pertain to the status of each object.  This is an effective communication tool which can be used to direct and track changes to the reports.

The status view can be accessed through the status icon found in the study conduct area.

>Status

Navigating the Status View

The status view consists of three columns of information pertaining to items found in the reports, programs and data objects.  The view is broken down by report type and is sorted by the order attribute within the report object.

The objects are preceded by checkboxes which allow users to pre-select items before they are updated through the Set Status button.  The Select All button for each column allows for quick selection of all the items within the column.  The objects selected by the check boxes will be highlighted as default selections within the update status dialog box available through the Set Status button. 

The objects shown in the status view contain hyperlinks which link to the report or documentation of that specific object.  For the report objects, the link will open a new window which contains the HTML version of the report as it was generated on the webserver through the %txt2html utility.  The program and data objects link to the documentation which was generated from the documentation tools.

Each object which appears in the status view is displayed with the status and author attributes.  Attributes can be updated for each object individually except for the source data object.  Source data comes from an external data management system so Trialex does not track them individually.   They are managed together with one status and author assigned to all source data.  

The programs and data that are shown in the same row as the report are used to generate the report.  This relationship is established from the dependency information.

The user can navigate from one report type to the next by selecting the report type pull down menu.  By selecting a different report type then the one currently shown, the screen will navigate to the list of the specified report type.

Updating Status Information

Every object that appears in the status view is followed by status and author information.  The word "Status" contains a hyperlink that drills down to the status attribute of that particular object.  For example, if the user clicks on the status hyperlink next to the report object for listing one, a screen will appear displaying the current status.

The status update screen allows for the re-assignment of both status and author.  Once the selection has been changed and the OK button is pressed, the status database will be updated with the new information.

It is optional to hold off on refreshing the status screens after an update is applied.  Since the refresh of the status screen takes time, it is recommended that the refresh be applied strategically.  Another recommendation for refreshing the status is to run the %status macro in a batch program.   This is an efficient approach to refreshing the status compared to refreshing it interactively.  If, however, the status view needs to be updated immediately, the Refresh button is available.

It is sometimes useful to apply status updates to multiple objects at once.  This can be accomplished by clicking on the Status Attribute button on the main status view.  The following dialog box is presented displaying all the objects available for update.

Multiple objects can be selected simultaneously and the status will be assigned according to the status selection.   Objects within this screen are pre-selected according to the items checked from the main status view.  Note that if only the status information is selected and the author is not specified, only the status attributes will be updated for the selected object.  In a similar manner, if only the author is selected, only the author attribute will be updated.   The updates of status for multiple objects affect the status database.  It is optional to have the status screen refreshed during an update or at a later time.   This option is similar to the single object status updates.

Sending an e-Note within Status

Every object that appears in the status view contains an author attribute which is displayed after the object name.   The author user name is also a hyperlink which drills down to e-Notes.

The e-Note composition screen is very similar to the ordinary e-Note.  The email will be sent to the author and the current user.  It will also send a CC to all members who have been defined to this study.  Members to a study are defined in the user privileges.  The subject is populated by the object type followed by object name.  The study name is populated within the email text.

In addition to being able to send an e-Note, the review of existing e-Notes for the current study is also available through the Review All Notes button.

Publishing Status View

The status view is an interactive screen displaying the most up-to-date information pertaining to the status of clinical objects.  It is therefore only viewable by a valid Trialex user.  In the event where the status information is useful for other users who are not Trialex users, a publish tool is available to export the status view so it can be viewed as a static HTML page. 

By clicking on the Publish button, a new HTML page is generated and populated on the web server in the default study path.

The URL to the snapshot view of the status is presented.  The status view generated will look similar to the interactive version except it will not have the drill down capabilities for setting status or e-Notes.  The advantage of the published status view is that it can now be seen by non-Trialex users or it can be emailed to external collaborators.

Status Metrics

A high level summarized view of the status information is essential for effective management of individual elements within a clinical data warehouse. The metrics report available through the Metrics button delivers a concise report that is summarized by report type. An example of the metrics report is shown below.

The columns are status categories which are defined by the Trialex System configuration.  The summary is a frequency and percentage count of reports, programs and data for the current specified study.  The reports are broken down by report type and displayed as a sub-report for more in-depth analysis.  These statistics are metrics which lead analysts or project managers can use to monitor and plan for optimal use of resources.