Program Overview
Clinovalife provides a comprehensive understanding of clinical data standards courses used in regulatory submissions for pharmaceutical and biotechnology studies. The course covers the CDISC standards lifecycle including CDASH for data collection, SDTM for data tabulation, and ADaM for statistical analysis datasets. Participants will also learn regulatory compliance processes including Pinnacle 21 validation and Define.xml metadata creation required for FDA and regulatory submissions.
Program Highlights
- End-to-End CDISC Standards Training
- Hands-on Understanding of CDASH, SDTM and ADaM
- Regulatory Submission Requirements (FDA/EMA)
- Pinnacle 21 Validation and Error Handling
- Define.xml Metadata Documentation
- Industry Case Studies and Practical Exercises
Course Curriculum
Module 1: Introduction to Clinical Research Data Standards
Module 2: CDISC Standards Overview
Module 3: CDASH Standards for Data Collection
Module 4: SDTM Fundamentals
Module 5: SDTM Domains
Module 6: SDTM Mapping Concepts
Module 7: SDTM Metadata
Module 8: ADaM Fundamentals
Module 9: ADaM Dataset Types
Module 10: Traceability Concepts
Module 11: Pinnacle 21 Validation
Module 12: Define.xml Metadata
Module 13: Regulatory Submission Requirements
Module 14: CDISC Implementation Workflow
Learning Outcomes
- Understand the CDISC standards framework
- Apply CDASH principles for data collection
- Map clinical data to SDTM domains
- Understand ADaM dataset structures for analysis
- Run Pinnacle 21 validation checks
- Create and interpret Define.xml metadata
Target Audience
- Clinical Data Managers
- Statistical Programmers
- Clinical Research Professionals
- Life Science and Pharmacy Graduates
Program Duration
Total Duration: 3 Months
Includes Practical Exercises and Case Studies
Tools Used
- Microsoft Excel
- Pinnacle 21 Community
- CDISC Library
- Sample Clinical Trial Datasets
- Metadata Documentation Tools
Certification
Participants who successfully complete the program and assessments will receive a Certificate in Clinical Data Standards.
Contact / Admissions
Email: Info@clinovalife.com
Phone: +91 XXXXXXXX
Website: www clinovalife.com
Phone: +91 XXXXXXXX
Website: www clinovalife.com