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?
In this webinar, we discuss a ‘designing with the end in mind’ approach. This includes:
- Designing optimal data collection eCRFs which balance ease of data collection whilst aligning to SDTM and NCI CT requirements.
- Designing target SDTM datasets and mapping these to raw datasets upfront.
What you will learn:
- Why the Clinical Data Acquisition Standards Harmonization (CDASH) design upfront is beneficial
- How to avoid delays in trial submission
- The benefits of aligning with the Clinical Data Interchange Standards Consortium (CDISC) from study design
- How technology supports compliant study design and build
- How technology enables earlier Study Data Tabulation Model (SDTM) conversions and faster access to data
Speakers: