Case report form auto-annotation in PDF files using SAS® ODS XML tagsets

Abstract

AbstractCase report forms (CRF) are essential tools in clinical research, used to gather data during the course of a clinical study. A common and useful task of data management personnel is to annotate the CRFs with appropriate variable names from the study data dictionary. Various authors have written on the topic of using SAS® to automate the annotation of CRFs, but with different approaches. We utilize a metadata database and XML tagsets to create an XML forms data format (XFDF) file for use with Adobe® Acrobat® Standard 7·0. The XFDF file is built utilizing a SAS® macro with user-defined content; the XFDF file is then imported into a portable data format file (PDF) containing the CRFs and the annotations are manually placed in the appropriate locations on the page. This process significantly increases the efficiency of our data management activities during study start-up. We have decreased our annotation work effort from several days to a 3 hour period.