Shradda Kulkarni, Assistant System Engineer at TCS (Tata Consulting Services, India)
The current COVID-19 pandemic has affected many industries around the world and the pharmaceutical industry is one of them. It is being presented with significant challenges related to conduct and handling of ongoing Clinical trials.
CDISC is a global committee that deal with the standardization of research data related to Life sciences and describes how to structure the data. In order to handle the current situation, CDISC has reformed its guidelines with updates in specific SDTM domains.
This presentation is covering the impact and changes in the SDTM standards that has been implemented in the ongoing studies along with future implications. On these lines we would further elaborate on the study procedures being missed and capturing additional information related to COVID-19 which would help analyze data more effectively with few examples.
Note: Publication of slides with the courtesy of Godfrey Machado, Senior Manager, Biostatistics & Programming at Tata Consultancy Services (July-02-2021)