SDTM Advanced + Hands-On Implementation

Training Description:

Enhance your expertise with our SDTM Advanced training, a comprehensive program with an instructor-led, Hands-On Implementation component. This immersive course provides an in-depth exploration of SDTM, covering both complex theoretical approaches and practical applications. Through interactive group activities and practical exercises, you’ll deepen your understanding of CRF annotation, creating and validating SDTM-conformant spreadsheets, and using the CDISC Open Rules Engine (CORE).

The hands-on component will focus on applying SDTM standards in a project-based setting, enabling you to practice and refine key standardization techniques in real-world scenarios. Join us to build the skills you need to confidently implement SDTM standards in your work.

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 of experience is recommended)

Certificates of Achievement and digital badges will be available for attendees who successfully complete this training.

PLEASE NOTE: Prior to the training start date, students will need to install CDISC Open Rules Engine (CORE) on their laptops or work computers to successfully complete assignments in class; you may need to receive prior permission from your company to install this software tool.

Target Audience:

Data Managers, Data Scientists, Data Analysts, Programmers

Method of Delivery:

In-Person: 2 Full Days (9am–6pm)

OR

Virtual (Microsoft Teams Meeting): 3 hours per day, 5 consecutive days