China CDISC Day Training

Course Description

CDASH Advanced Topics explores more complex topics drawn from real-world examples, including how and when to use Findings About (FA) in CDASH for events and interventions, a forensic examination of exposure (EX) and exposure as collected (EC), and the application of associated persons (AP) data with implementation examples.

Prerequisites

• A working-level understanding of clinical research
• Practical implementation experience with CDASH standards (at least one year experience is recommended)

At the end of this course, learners will be able to:

• Describe how FAIR principles apply to CDISC standards
• Model a selection of more complex data structures based on more detailed understanding of SDTM approaches, including relative timing variables, EX and EC, biospecimen events and lab-like data
• Apply some more recently-developed variables to your studies, such as collected summary result
• Analyze conformance rules, determine their likely origins, and by extension locate effective resources for implementation clarification

Continuing Education Unit(s):

The learner must receive a score of 80% or higher on the Final Assessment to earn 0.7 IACET CEUs.

Course Description

The SDTM Advanced Topics training explores topics beyond SDTM Theory and Application, including complex SDTM modeling. Course topics are drawn from real-world examples identified through the standard development process as well as by the CDISC user community and our expert SDTM instructors. 

Topics include the following: Timing Variables, Advanced Controlled Terminology Implementation, Findings About and Outcomes of OCCUR, The EX and EC Domains, Changes in Severities, Linking Data, Conformance Rules and Requirements, Associated Persons, Biospecimen Events, Lab-related data, --CAT & --SCAT Variables, Drug Classes, The 'Collected Summary Result Type' Variable

Prerequisites

• A working-level understanding of clinical research
• Practical implementation experience with SDTM standards (at least one year experience is recommended)

At the end of this course, learners will be able to:

• Describe how FAIR principles apply to CDISC standards
• Model a selection of more complex data structures based on more detailed understanding of SDTM approaches, including relative timing variables, EX and EC, biospecimen events and lab-like data
• Apply some more recently-developed variables to your studies, such as collected summary result
• Analyze conformance rules, determine their likely origins, and by extension locate effective resources for implementation clarification

Continuing Education Unit(s):

The learner must receive a score of 80% or higher on the Final Assessment to earn 1.1 CEUs.

After purchasing a training, you will automatically receive a Confirmation Email with the following:

• an order number
• link to the CDISC Learning Management System (LMS)

You can immediately access the online training materials in the LMS.

Within 24 hours, you will be assigned to your specific seminar event.

You will receive a Training Booking Confirmation Email with the following:

• event details (including required check-in information and contact information for an MSD China on-site point person)
• an iCal attachment

Please contact us if you do not receive these emails within 24 hours.