Elevating CDISC SDTM Deliverables: A Blueprint for Accelerated Execution

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!

In this presentation, 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.

The big win?

With this approach, SDTM conversions can be done as soon as patient data is collected. Plus, conversions can be run throughout the trial, allowing clinicians to analyze and visualize data immediately, and make timely safety and efficacy decisions.

Now continuous quality monitoring during a study is possible. Coupled with the benefits of early data visibility, this will speed therapies to market faster than ever before.

Who Should Attend:

This webinar will benefit those responsible for or involved in the selection of a clinical metadata repository. It will also benefit those looking to introduce standardization into their clinical trial design and build process. This includes people working on data standards, data management, regulatory compliance (including CDISC) and governance in pharma's, biotech's, CROs, universities and medical device organizations, including:

• Regulatory Affairs
• Clinical Operations
• Clinical Affairs
• Project Management

What You Will Learn:

In this webinar, attendees 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