[Overview of CDISC standard and implementation in China]

Area of Science:

• Clinical research data management
• Regulatory affairs
• Pharmaceutical sciences

Background:

• The Clinical Data Interchange Standards Consortium (CDISC) provides global data standards for clinical research.
• These standards cover the entire lifecycle of clinical studies and have undergone significant development and upgrades.
• CDISC adoption facilitates data exchange and communication among stakeholders, improving research quality and efficiency.

Purpose of the Study:

• To highlight the global adoption and benefits of CDISC standards in clinical research.
• To discuss the gradual implementation and ongoing exploration of CDISC standards in China.
• To assess the feasibility and roadmap for adopting CDISC as a Chinese data submission format.

Main Methods:

• Review of CDISC standard development and its impact on clinical research.
• Analysis of regulatory authorities' adoption of CDISC for data submission.
• Examination of CDISC implementation within the global pharmaceutical community.
• Exploration of China's current efforts and pilot programs for CDISC adoption.

Main Results:

• CDISC standards improve clinical research quality, efficiency, and drug review processes.
• Multiple regulatory authorities have adopted or plan to adopt CDISC standards.
• The global pharmaceutical community widely implements CDISC standards.
• China is actively exploring and piloting the adoption of CDISC standards for data submission.

Conclusions:

• CDISC standards are crucial for global clinical research data harmonization and efficiency.
• The adoption of CDISC in China is progressing, with ongoing efforts to define its role in regulatory submissions.
• Successful implementation of CDISC in China is expected to enhance data exchange and streamline drug development processes.