Streamlining Clinical Trial Data Integrity: A Simple Method for Integrating Analysis Result Metadata into Existing Define.xml 2.0
Introduction
Clinical trials play an important role in the development of new drugs and therapies. The regulatory authorities require sponsors to submit the data from these trials in a standardized format called the define.xml. Analysis Result Metadata (ARM) adds significant value to a regulatory submission by providing a means for reviewers to trace results back to their source documents, such as key pieces of SAS programs used for analysis, datasets, data selection criteria, and even specific pages in a statistical analysis plan. This article describes a simple method for integrating ARM in existing define.xml version 2.0 using an Excel spreadsheet designed to collect the necessary information.
Collecting the Necessary Information for ARM
The document from CDISC “Analysis Results Metadata v1.0 for Define-XML v2.0” specifies a list of required or optional elements of ARM for define.xml version 2.0. In order to collect information for populating these elements, an Excel spreadsheet was designed that study statisticians or study programmers can easily fill out. The spreadsheet includes columns for the following information:
Table No: A unique table number to be included in ARM, which can contain special characters such as “.”, “_”.
Table Name in PDF: The unique name of the CSR table in PDF format.
Table Page No: If desired, the page number can be supplied so that a link will be created to that page in define.xml.
Table Description: A brief description of that analysis table.
Dataset Name: The ADaM dataset that the analysis is based on.
Analysis Parameter: The parameter that the analysis is based on, usually it is “PARAMCD”.
Analysis Variable: The variable name that contains the value for the analysis, usually it is “AVAL” or “AVALC”.
Analysis Purpose: The purpose of the analysis, such as efficacy outcome measure.
Selection Criteria: The ID or identifier for selection criteria. It has to match the one in the Selection Criteria section in define.xml, otherwise the link will not work. An error will be captured in Pinnacle 21 when performing schema validation if there is such a mismatch.
Documentation: Further explanation of the analysis.
Documentation Name: The PDF name of the documentation, such as sap.pdf.
Documentation Page Number: If desired, the page number can be supplied so that a link in define.xml will be created to that page of documentation in PDF format.
Comments: Any additional comments if applicable.
Programming Statement: Key SAS code snippet that will be included in ARM.
Name of SAS Source Code in text format: The file name of the text file that contains the Key SAS code.
SAS Version: SAS version number, such as 9.3 or 9.4.
Integrating ARM into Define.xml
Once the necessary information has been collected in the Excel spreadsheet, a macro can be used to convert the collected information to ASCII text in valid xml syntax and add them to the appropriate locations in existing define.xml. The resulting define.xml file includes all the necessary ARM features and passes Pinnacle 21 define.xml schema validation, making it ready for submission to regulatory authorities.
Conclusion
Integrating ARM in existing define.xml files is an important step in ensuring the accuracy and integrity of clinical trial data submitted to regulatory authorities. An Excel spreadsheet has been designed to collect the necessary information for ARM, and a simple method using a macro has been developed to add ARM to existing define.xml files. This method has been shown to be effective in creating define.xml files that include all the necessary ARM features and pass Pinnacle 21 define.xml schema validation. By including ARM in define.xml files, sponsors can provide regulatory authorities with the necessary information to trace the results back to their source documents, ensuring the integrity of clinical trial data.
