Module 12 2019

US Requirements for Clinical Data

• Study reports • Supported by Case Report Forms and Case Report Tabulations for clinical studies and tabulated data for nonclinical studies • Used for independent analysis of study data and conclusions • Paper tabulations are not “user friendly” and were replaced by sas.xpt files in 1997/1999 • Not standardized until 2004 (CDISC)

At the study level applicants submit:

The Organisation for Professionals in Regulatory Affairs