SDTMIG

Introduction

SDTMIG: The Study Data Tabulation Model Implementation Guide (SDTMIG) for human clinical trials guides users on the organization, structure, and format of standard clinical study tabulation datasets for interchange between organizations or to be submitted to a regulatory authority. The following videos introduce you to the SDTMIG and the SDTM, which used together serve as a map that orients you on how your data fits into the standard.


Versions

A Study Data Tabulation Model Implementation Guide (SDTMIG) is developed in reference to a specific SDTM model. However, the SDTM is cumulative – each new release builds on the previous model. Therefore, the models are backward compatible. For example, SDTMIG-AP v1.0 was developed in reference to SDTM v1.4, but it may be used in a submission that uses SDTM v1.7.

Implementers should be aware that if they are referencing a model for which the IG was not originally developed, variables may have been added or deprecated from the model. In addition to models and implementation guides, conformance rules have been developed, which help to ensure that generated data structures conform to the standards. These rules aim to identify all conformance rules and case logic from the SDTM and SDTMIG, classifying and codifying them in a form that supports quality processes and tool development.

Therapeutic Area User Guides

Controlled Terminology

Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. The following video introduces you to CDISC Controlled Terminology and how it is used with CDISC standards.

Traceability

Traceability is a fundamental element of data quality and a requirement for studies submitted to regulatory authorities. From data collection to final analysis, traceability plays a crucial role in ensuring the integrity of source data and in reinforcing clinical research results. The following video provides an introduction to implementing traceability in CDISC-compliant studies.

Regulatory Requirements

CDISC standards are required or recommended by several global regulatory agencies. Standardized data enables regulators to streamline the review process with a more consistent use of analysis tools to better view drug data and highlight areas of concern. The following video introduces you to regulatory requirements and the use of CDISC standards.

Team Guiding Principles

Standards in Development

Foundational

For current versions of the standards, please visit the Standards Home Page.


Standard Release Notes Projected Publication
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement

Resolving Public Comments.

2020
ADaM OCCDS v1.1

Preparing for Publication.

2021
ADaM Oncology

In Development.

2021
ADaM Traceability Examples

In Development.

2021
ADaMIG Medical Devices v1.0

In Development.

2021
ADaMIG Non-compartmental Analysis v1.0

Public Review runs through 15 Jan 2021.

2021
CDASH SAE Supplement v2.0

Public Review run through 06 Jan 2021

2021
CDASH v1.2

In Development.

2021
CDASHIG v2.2

In Development.

2021
Conformance Rules v1.2 for SDTM v2.0 and SDTMIG v3.4

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SDTM Metadata Submission Guidelines v2.0

Resolving Public Comments.

2020
SDTM v2.0

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SDTM Variable Definitions

Resolving Public Comments.

2020
SDTMIG v3.4

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SEND Conformance Rules v2.0

Resolving Public Comments.

2020
SENDIG v3.1.1 Preparing for Publication. 2021

Data Exchange

For current versions of the Data Exchange standards, please visit the Data Exchange Page.


Standard Release Notes Projected Publication
Conformance Rules v1.0 for Define-XML v2.1

Public Review runs through 15 January 2021.

2021
ODM v2.0

In Development.

2021

Therapeutic Areas

For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.


Therapeutic Area Release Notes Projected Publication
Crohn's Disease Therapeutic Area User Guide v1.0

Work Package 1: Resolving Public Comments.

Public Review for Work Package 2 runs through 4 Dec 2020.

2021
Diabetes - Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules

Resolving Public Comments.

2020
Pancreatic Cancer Therapeutic Area User Guide v1.0

In Development.

2021
Traditional Chinese Medicine - Acupuncture

In Development.

2021

Knowledge Base

Education