Conference Description:

Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end?

A retrospective approach is fraught with risk. What if some of the required data is missing? Will it be possible to retrofit datasets and terminology into the CDISC SDTM and NCI Controlled Terminology models? Will the submission be compliant?

This time-consuming data wrangling distracts resources from the important business of delivering a high quality submission package – before the deadline!

Register for this webinar and hear from leading industry experts about designing studies with the end in mind — and how technology can be leveraged to facilitate this.