Using ODS and PROC Report to Generate in-Text Tables for a Clinical Study Report (CSR)

• Activity Number: 313
• Type: Contributed
• Date/Time: Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Faye Yeh*+
• Companies: Takeda
• Keywords: SAS programming ; ODS ; PROC REPORT ; in-text table ; CSR ; clinical study report

Abstract

In clinical research studies, in-text tables are commonly used to provide a clear and effective presentation of data in clinical study reports (CSR). However, these tables are often generated manually, which is time-consuming and is very much prone to typing error. After working with a medical writing group, a set of commonly used safety in-text tables were identified and standardized. Template programs with SAS® ODS and PROC REPORT application were generated to produce these in-text tables. The output generated by these template programs can be copied and pasted directly into the body of a CSR as in-text tables. This process requires a minimum manual operation and has improved the efficiency and accuracy of CSR. Also, these in-text tables can be used to validate the end of text tables (since both outputs are based on the same clinical database).