Date: Pre Selected Date
Location: NBL Cherlapalli IDA Branch
Facilitator(s): NTHRYS TEAM
8:00 AM - 8:30 AM: Registration and Welcome Coffee
Participants arrive, register, and network over coffee.
8:30 AM - 8:45 AM: Opening Remarks
Welcome by the host.
Brief overview of today's focus.8:45 AM - 10:15 AM: Session 1: Basics of CDISC SDTM
Overview of CDISC SDTM and its significance.
Introduction to the standards and guidelines for clinical data submission.10:15 AM - 10:30 AM: Coffee / Tea / Snacks Break
Networking and refreshments.
10:30 AM - 12:00 PM: Session 2: SDTM Domains
Hands-on training on understanding and implementing SDTM domains.
Practical session on mapping clinical data to SDTM domains.12:00 PM - 1:00 PM: Lunch Break
Catered lunch and networking opportunity.
1:00 PM - 2:30 PM: Session 3: SDTM Implementation
Overview of the implementation process for SDTM.
Practical exercises on creating and validating SDTM datasets.2:30 PM - 2:45 PM: Short Break
Time for a stretch and informal discussions.
2:45 PM - 4:15 PM: Session 4: Case Studies in CDISC SDTM
Discussion on real-world case studies in CDISC SDTM.
Analysis of challenges and best practices in SDTM implementation.4:15 PM - 4:30 PM: Coffee / Tea / Snacks Break
Last networking opportunity with snacks.
4:30 PM - 5:30 PM: Closing Session: Implementing Changes and Technology Adoption
Group discussions on implementing new techniques learned today.
Dialogue on overcoming challenges in adopting new technologies in similar sectors.
Feedback session and closing remarks.
Certificate Issue5:30 PM: Workshop Concludes
Date: Pre Selected Date
Location: NBL Cherlapalli IDA Branch
Facilitator(s): NTHRYS TEAM
8:00 AM - 8:30 AM: Registration and Welcome Coffee
Participants arrive, register, and network over coffee.
8:30 AM - 8:45 AM: Opening Remarks
Welcome by the host.
Brief overview of today's focus.8:45 AM - 10:15 AM: Session 1: Advanced SDTM Mapping
Introduction to advanced techniques in SDTM mapping.
Practical demonstration of complex data mappings and transformations.10:15 AM - 10:30 AM: Coffee / Tea / Snacks Break
Networking and refreshments.
10:30 AM - 12:00 PM: Session 2: SDTM Validation and Compliance
Overview of validation and compliance requirements for SDTM.
Hands-on workshop on validating SDTM datasets and ensuring compliance.12:00 PM - 1:00 PM: Lunch Break
Catered lunch and networking opportunity.
1:00 PM - 2:30 PM: Session 3: Integration with Other Standards
Introduction to integrating SDTM with other clinical data standards.
Practical session on mapping data between SDTM and other standards like ADaM and CDASH.2:30 PM - 2:45 PM: Short Break
Time for a stretch and informal discussions.
2:45 PM - 4:15 PM: Session 4: Regulatory Submissions
Discussion on the role of SDTM in regulatory submissions.
Case studies on preparing SDTM datasets for FDA and EMA submissions.4:15 PM - 4:30 PM: Coffee / Tea / Snacks Break
Last networking opportunity with snacks.
4:30 PM - 5:30 PM: Closing Session: Implementing Changes and Technology Adoption
Group discussions on implementing new techniques learned today.
Dialogue on overcoming challenges in adopting new technologies in similar sectors.
Feedback session and closing remarks.
Certificate Issue5:30 PM: Workshop Concludes
Date: Pre Selected Date
Location: NBL Cherlapalli IDA Branch
Facilitator(s): NTHRYS TEAM
8:00 AM - 8:30 AM: Registration and Welcome Coffee
Participants arrive, register, and network over coffee.
8:30 AM - 8:45 AM: Opening Remarks
Welcome by the host.
Brief overview of today's focus.8:45 AM - 10:15 AM: Session 1: SDTM and Real-World Data
Introduction to the use of SDTM for real-world data integration.
Practical session on mapping real-world data to SDTM standards.10:15 AM - 10:30 AM: Coffee / Tea / Snacks Break
Networking and refreshments.
10:30 AM - 12:00 PM: Session 2: Automation in SDTM
Overview of automation tools and techniques in SDTM.
Hands-on workshop on using software tools to automate SDTM mapping and validation.12:00 PM - 1:00 PM: Lunch Break
Catered lunch and networking opportunity.
1:00 PM - 2:30 PM: Session 3: SDTM in Oncology Studies
Discussion on the application of SDTM in oncology clinical trials.
Practical exercises on mapping oncology-specific data to SDTM.2:30 PM - 2:45 PM: Short Break
Time for a stretch and informal discussions.
2:45 PM - 4:15 PM: Session 4: Future Directions in CDISC SDTM
Exploration of future trends and innovations in CDISC SDTM.
Case studies on cutting-edge research and its impact on clinical data management.4:15 PM - 4:30 PM: Coffee / Tea / Snacks Break
Last networking opportunity with snacks.
4:30 PM - 5:30 PM: Closing Session: Implementing Changes and Technology Adoption
Group discussions on implementing new techniques learned today.
Dialogue on overcoming challenges in adopting new technologies in similar sectors.
Feedback session and closing remarks.
Certificate Issue5:30 PM: Workshop Concludes