Introduction

Capturing the source location of variables is an important task during documentation.  If the variable is a source variable from a case report form, the Trialex System can store the location of the PDF version of the annotated CRF for documentation purposes.  The location also includes bookmarks or local links to the specific variable view.  The location of this CRF can be used as a hyperlink in the documentation as shown in this example.

The documentation shown here is generated from the %datadef utility.  If a variable has been assigned to an annotated CRF location, a hyperlink is automatically generated.   

The assignment of the annotated CRF location is found within the study conduct area.  From the study conduct area, the annotated CRF selection icon is found one level below the documentation icon.

The annotated CRF selection tool is organized by a set of five sequential dialog boxes which walks the user through the selection process.

Selecting CRF Location

The first step in the CRF selection is to identify physical location of the case report form on a web server.   The reason that the CRF needs to be on a web server is that during the compilation of the documentation, all the hyperlinks are created over the web server.  If the CRF are not on the web server, the hyperlinks will not be recognized and the CRF will not be included.

The path that is required is the physical path on to the web server which contains the CRF files stored in PDF format.

Selecting CRF

The second step is to identify the specific case report form that resides inside the specified location.  The dialog box will list all the PDF files that exist in the specified location.

Selecting Bookmark

A bookmark is a link to a specific view within a PDF page.  This allows for the link to the specified PDF page along with the zoom view on a particular variable within that page.  The zoomed view has a corresponding bookmark name.  This is captured in the third screen.

The PDF file specified on this page also acts as a live hyperlink to the specified PDF page.

Associating CRF with Variable

The last steps are to associated the CRF location to the specific variable within a data set.  The Trialex System first requests for the data set which contains the variable.

Note that during every step of the process, the selections are documented at the top.  The last dialog box presents all the variables within the selected data set.  The system then associates the variable with the location of the CRF and the hyperlink is generated during the final documentation.