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A major topic of discussion during this session was around the utilization of CDASH and using standards even further upstream to Protocol Representation Standards, raised by Drs. Steve Wilson and Ben Vali of FDA. Dr. Rob Dicicco spoke about the TransCelerate Standard Protocol Template project, the team having met earlier in the week with leadership from the CDISC Protocol Representation Standards team. Dr. Ron Fitzmartin reiterated the FDA’s position on using standards from the start by stating, “We promote CDASH strongly, as with traceability that is critical.”


While the panelists did emphasize the economic benefits of standards utilization from the start, including the use of EHRs for research, there was also a very heartfelt focus on the patient during this session, and how utilization of the standards upfront can be to the benefit of patients who need safe and effective treatments. Trisha Simpson of UCB discussed how FDA and sponsors must have the ability to find and use data. She stressed that “standards are about people; it’s about your family.”


By Andrea Vadakin, CDISC Public Relations Manager


Strength through Collaboration


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