Overview
You can produce common system level reports for CDISC Builder.  These are not necessarily pertaining to CDISC data structures but include information such as:

• Audit Trail
• Contents and Print
• Traceability

These reports can be accessed through the REPORT icon from the main CDISC Builder screen.  The selection of the report can therefore be selected with the following screen.

Audit Trail
It is very useful to be able to figure out what has been applied to your data in a complete audit trail.  This information can help you determine where discrepancies are introduced since you are able to track changes.  The audit trail report will provide information including what tools were applied to which data and by whom.  An example report will include the following information:

• CDISC Builder Tool Applied - Document which CDISC tool was applied 
• Input Data - Input SAS dataset in this operation
• Input Data Path - The physical path on the server in which this task was applied
• Output Data - Output SAS data that was produced as a result of this operation
• Output Data Path - The physical path on the server in which the output data was produced
• SAS Program - Associated SAS program produced which produced this operation
• Output Report - Report generated as a result of the operation
• User Name - The user who applied the task
• Updated Date Time - The date and time which this report was generated

This report provides a complete audit trail of all operations applied through CDISC Builder.  The report also provides hyperlinks to associated report items.  The hyperlinks open up a new window documenting the following information including: input data path, output data path, SAS program, and output report.  

Contents and Print
One of the first and common task applied to datasets before working on them is to perform a PROC CONTENTS and PRINT on the data.  This allows you to see both the structure and contents of the data.  This tool allows you to perform the task quickly with a few clicks.  The PROC PRINT would result in a very large report so if the data is over 100 observations, the report will only display the first 100 rows.

The contents screen allows you to select the data and associated options for the CONTENTS component of CDISC.  The data flow for this tool is shown here.

Source Data

CDISC Builder Contents

HTML Report with PROC PRINT/CONTENTS

The options available for selecting data and options for CONTENTS are:

• Source Data - This is the location of the dataset that is going to have PROC PRINT and CONTENTS applied.
• Select All - This allows the user to select all the dataset that is in the selected library source path.
• CDISC - This will select all datasets that have the matching name with prescribed CDISC domain datasets.
• Report Type - This will determine if either a PROC REPORT or a PROC CONTENTS will be applied.  It will also have the option to apply both.
• Output File - The HTML report will be generated at a specified path captured by this parameter.
• Save Code - The code saved in this location will contain a macro call capturing all the options that has been selected.  This can therefore be executed independent from this interface as a SAS program.

Multiple or all datasets can be documented and report at once.   You can either select on the Select All button or click on each dataset listed holding on the control or shift key.

Traceability Report
One of the requirements of CRF Part 11 is to be able to provide documentation of traceability of your output.  This means that for all the data submitted, you would have to document how the data was derived.  The ability to therefore trace from the output data to its source is essential.  This report documents this process.  You would first select the data in which you wish to generate this report from the following screen.

A sample report that is generated for traceability would look like: