CDISC SDTM (Study Data Tabulation Model) Course

CDISC ADaM (Analysis Data Model) Course

The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications

The ADaM (Analysis Data Model) is a specification in the FDA eCTD Guidance as the model for submitting analysis datasets to the FDA in support of marketing applications.

Course Description and Learning Objectives

This class consists of

This course discusses

1) a detailed review of SDTM concepts, SDTM domain models, and relationship tables,
2) a discussion of common implementation issues, and
3) a workshop with CRF-annotation exercises that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide.

1) the purpose of analysis datasets and the basic principles of the ADaM data standard,

2) how ADaM fits in the CDISC framework, and

3) the relationship between ADaM and SDTM.

The audience will learn

The audience will learn

1) The theory behind SDTM and the format of data that will be required for submission to the FDA.

2) Key SDTM concepts.

3) How to represent various types of collected data in the SDTM format.

1) The theory behind ADaM and the format of data that will be required for submission to the FDA.

2) Basic principles of the ADaM Standard Model, as presented in the ADaM Implementation Guide.

3) Types of metadata and their uses.

SDTM Training Program (2 days)

ADaM Training Program (1 day)

1st day AM

• CDISC Mission

• Background on CRT (Case Report Tabulation) and FDA guidances

• SDTM history and maintenance process

• FDA Critical Path Initiative

• SDTM basic concepts

• Introduction to SDTM general classes and special purpose models

• Screen shots of SDTM reviewer tools

• Background and Introduction (CDISC, Standards, FDA)

• Purpose of Analysis Datasets

• Fundamental Principles of ADaM

• ADaM Subject Level Analysis Dataset (ADSL)

• ADaM Basic Data Structure

• ADaM Standard Variables

• ADaM Metadata

• ADaM Implementation Guide Examples

1st day PM

• Model concepts and terminology

• Detailed review of general observation classes

• Core model assumptions

• SDTM metadata model

• SDTM standard domains

• Creation SDTM custom domains

2nd day

• Principles of RELREC and SUPPQUAL for storing relationships between datasets, variables, and observations

• Trial Design concepts