CDISC® Mapping

"Thanks for the class, it has been great for filling in the blanks in my knowledge (which were considerable!) and making me feel more confident about the CDISC systems!", Cheers,Jocelyn Baker, UCSD Extension Online class student, Summer 2015 

 

(See more student quotes)

 

CDISC Mapping and Strategies Class Outline

 

I. CDISC Specifications and FDA Requirements

  a. CDASH, Study Data Standardization Plan and Submission

      Data Standards

  b. SDTMs and ADaMs Specifications

  c. Metadata files and Control Terminology

  d. DEFINE.XML and DEFINE.PDF

 

II. Understanding Concepts and Applying Mapping Plan

  a. CDSIC MindMaps and References

  b. Compare and Contrast SDTM and ADaM Steps

  c. ADaM Models – ADSL, BDS and ADAE

  d. SDTMs and ADaMs 80/20 Mapping Rule

    i. 80% General Variables (SDTM, ADaM)

    ii. 20% Special Variables (SDTM, ADaM)

    iii. ADaM and SDTM Mapping Variables

  e. ISO8601 Dates, Partial Dates, Durations and Periods

 

III. QC, QA and Best Practices to establish Controls and Quality

  a. Study Validation Checklists

  b. SDTM and ADaM QC Forms

  c. OpenCDISC and SAS Clinical Standard Toolkit

  d. Templates – SDTM and ADaM Specifications, Defaults, Master SDTM to ADaM Map

  e. ISS/ISE – Master Control Terminology

 

IV. FDA’s Review Process and Issues

  a. Understanding the FDA Review process and preventing delays - FDA’s High Expectations     b. Understanding how to avoid FDA Review issues - Challenges

  c. Sponsor’s Best Practices for better FDA Submissions - Lessons Learned