Best Practice for CDISC Standards Implementation and Uses Cases Demonstrating Successful Adoption

Auditorium

Ignite Session

Regulations & Standards

Information

Session chaired by Gilbert Hunter

Description:

Adopting CDISC standards isn’t just a regulatory necessity. It’s an important investment that enables more meaningful research and data insights. While complying with CDISC data standards is an ongoing challenge for many sponsor organizations, the many benefits outweigh the challenges.

Our presentation will demonstrate best practice processes to achieve successful implementation of CDISC standards and compliance with regulatory requirements. We’ll examine the concept of ‘designing studies with the end in mind,’ through early standards adoption. We’ll look at how implementing industry standards from the start of a study is the ultimate blueprint for best practice. We’ll cover how to establish organizational standards, create an approved metadata content library, and associated governance and approvals processes.

We’ll explore the many benefits of CDISC data standards adoption, including:

Time savings
Resource efficiencies
Better metadata quality
Easier metadata reuse
Greater consistency across studies and standards
Governance, visibility and control

We’ll demonstrate these benefits using real world examples from leading pharmas, biotechs, and academic institutes. We’ll also tackle real-world challenges that organizations face in the process of adopting CDISC standards, including:

Lack of CDISC knowledge internally
The culture shift required when learning and adopting the new methods
Finding the budget to invest in standardization
The requirement to retrospectively map to SDTM

Finally, we’ll examine the impact of standardization on trial set up effort and form reuse over time, as demonstrated by a real-world use case.

In conclusion, we’ll cover the best practice methods for successful adoption of CDISC standards. Using several case studies, we’ll show how end-to-end standards implementation can be leveraged to not only achieve compliance, but also facilitate greater quality and consistency, and faster submission. We’ll show that no challenge when implementing CDISC compliance is insurmountable, and that the benefits of adopting the CDISC format are well worth the effort.

Learning Objectives: