SDTM Advanced + Hands-On Implementation

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

• 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 more recently-developed variables to clinical studies, such as collected summary result
• Analyze conformance rules, determine their likely origins, and by extension locate effective resources for implementation clarification
• Apply Metadata Submission Guidelines
• Explain how to create traceability
• Use the Data Standards Browser
• Use CORE to validate data
• Manually identify issues that cannot be identified with a validation tool

Overview:

On Day #2 of the SDTM Advanced training, attendees will participate in a 4-hour hands-on workshop covering key aspects of SDTM implementation, including annotating according to Metadata Submission Guidelines, validating data using CORE, and creating traceability.

Target Audience:

Data Managers, Clinical Data Scientists, Clinical Data Analysts, Programmers

Objective:

Provide participants with practical, hands-on experience in implementing SDTM from data collection to submission-readiness.

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 
• an iCal attachment

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