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.

Version Related
SDTMIG v3.4

SDTM v2.0
SDTM and SDTMIG Conformance Rules v2.0
SDTMIG v3.3

SDTM v1.7
SDTMIG for Medical Devices v1.1
SDTMIG-AP v1.0
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
SDTM Metadata Submission Guidelines v2.0
SDTMIG v3.2

SDTM v1.4
SDTMIG for Medical Devices v1.0
SDTMIG-AP v1.0
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2
SDTMIG for Medical Devices v1.1

SDTM v1.7
SDTMIG for Medical Devices v1.0

SDTM v1.4
SDTMIG-AP v1.0

SDTM v1.4
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3

Therapeutic Area User Guides

Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertains to specific disease areas. TAUGs include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions. The following video will introduce you to TAUGs and how they relate to CDISC Foundational Standards.

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

Statement:

Coordinate across standards teams and within SDS. Refer to guiding priniciples, published models, implementation guides (IGs), and therapeutic area user guides (TAUGs) when debating how to model data.

Rationale:

Decision consistency during consultation and development leads to the production of higher quality products. Inconsistent decision making leads to incorrect usage or inconsistent use of standards. This, in turn, leads to confusion within the user community.

Key Benefits:
  • Ensures consistency across IGs, conformance rules, and TAUGs
  • Facilitates alignment of decisions made by different foundation and therapeutic area teams
Actions you can take:

Follow published rules; be mindful of precedent setting.


Statement:

Provide timely support for developing new projects and when teams approach SDS for consultation.

Rationale:

Timely support during consultation and development leads to the production of higher quality products.

Key Benefits:

Allows predictability and alignment with project timelines and publications.

Actions you can take:
  • Be accountable to complete support steps for given projects and consultation.
  • Read pre-reads as available for full-team meeting.
  • Bear in mind time provided for a topic of discussion.
  • Determine short- and long-term solutions as needed.
  • Form subteams as needed to address issues, but set goals and time limits for the decisions to be made.

Statement:

Coordinate across standards teams and within SDS. Be mindful of the impact of changes to the SDTM and SDTMIG and other CDISC standards.

Rationale:

Changes and updates may affect the work of implementers. Significant alterations to the SDTM and SDTMIG used by multiple user communities should be communicated to all stakeholders.

Key Benefits:
  • Decreases the amount of changes the user community has to implement
  • Decreases the cost in time and money of versioning
  • Decreases the introduction of errors within company standards
  • Minimizes unnecessary or unproductive changes
Actions you can take:
  • Bear in mind the processes in place for requesting new domains or changes to the standard. 
  • Refer to the SDS Decision Tree for the appropriate steps to follow when considering new activities (e.g, an idea, a new project or proposal).
  • Change requesters should always check the most recent model, IG, and non-standard variable registry before submitting change requests.
  • Change requesters should check with the appropriate foundational teams to determine impact. Feedback should be solicited from all foundational teams.

Standards in Development

Foundational

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


Standard Release Notes Projected Publication
ADaM Oncology Examples

Resolving Public Comments

 2023
ADaM popPK Implementation Guide v1.0

Preparing for Publication

 Q3 2023
ADaM v3.0

In Development

 2025
Analysis Results Metadata (ARM) Conformance Rules

In Development

 2024
Analysis Results Standards v1.0

In Development

 2024
CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1

Public Review through 18 September

 Q4 2023
Safety User Guide v1.0

In Development

 2024
SDTM for Observational Studies v1.0

Public Review through 28 September

 Q4 2023
SDTM v2.1

Resolving Internal Review Comments

 Q4 2023
SDTM v2.2

In Development

 2024
SDTMIG v4.0

In Development

 2025
SEND Tumor Combinations v1.0

Preparing for Publication

 Q3 2023
SENDIG v4.0

In Development

 2024
Tobacco Implementation Guide v1.0

Resolving Internal Review Comments

 Q4 2023

Data Exchange

Therapeutic Areas

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


Therapeutic Area Release Notes Projected Publication
Rare Diseases Therapeutic Area User Guide

Resolving Public Review Comments

 Q3 2023

Knowledge Base

Articles
A Short History of CDISC and SAS Transport Files
Are These Findings Just Repeats or Were They Scheduled at Time Points?
Avoiding SDTM and ADaM Dataset and Variable Name Conflicts
Can I add this variable to my SDTMIG dataset?
CDISC-Annotated CRF Repository in Japanese
Changing Event Severity
Concept Maps for a Finding with Increasing Levels of Detail
Concept Maps for Adverse Events with Increasing Levels of Detail
Concept Maps for Substance Administration with Increasing Levels of Detail
Considerations for Using CDISC Standards in Observational Studies
Do I have to use the variable labels in the SDTMIG?
Does QNAM Need to Start with a Domain Code?
Domain vs. Dataset: What's the Difference?
Domains are Topic-based, Except When They're Based on Structure
How Do I Represent a Pre-specified Finding?
How should I represent whether a physical exam was performed in SDTM?
IS Domain Scope Update for the SDTMIG v3.4: A Development History and the Difficulties of Standardizing Complicated Biological Processes
LOINC and the SDTM
Pre-specified Events and Pre-specified Findings
Providing Review-Ready Results in SDTM
SDTM and CDASH: Why You Need Both
SDTM Timing Variables for Pre-study Findings
Sex and Gender
Special Values: "MULTIPLE" and "OTHER"
Standardized Lab Units
Study Subject Site Transfers Example
Study Subject vs. Experimental Unit
Subject Visits and COVID-19
TAUG Examples of SDTM Domains
Translating CDASH "PRIOR" and "ONGO" to SDTM relative timing variables
UCUM and CDISC Codelists
Variable Metadata Has Changed in SDTM v2.0. How Does This Affect SDTMIG v3.4?
When Would I Use ISO8601 Interval Format?
Where Does My Lab Data Go in SDTMIG v3.4?
Why Are Certain SDTM Variables "Not for Use in Human Clinical Trials"?
Why is an Image like a Specimen?
Why Not Just Use SNOMED?
Why Would a Standards Development Organization Make Non-standard Variables Available on their Website?
Examples
All-cause Death
Body Sites of Psoriasis Involvement at Baseline
Body Surface Area of Involvement (BSA)
Calculated Dose
Cardiac Surgery as an Acute Kidney Injury Risk Factor
Death
Diabetes Diagnosis
Diabetes History 1
End-Stage Renal Disease
Glomerular Filtration Rate 1
Glomerular Filtration Rate 2
Heart Failure Background Maintenance Medications
Heart Failure Lab Tests
Heart Failure Medical History
Hospitalization for Heart Failure
Hypoglycemic Blood Glucose 1
Hypoglycemic Last Meal 1
Patient Global Impression
Phototherapy Administration
Prior Phototherapy
Proteinuria
Psoriasis Diagnosis
Renal Death 1
Renal Replacement Therapy
SDTM Prior Treatments and Vaccination History
Serum Creatinine and eGFR
Static Physician Global Assessment
Target Lesion Assessment
Tolerance Test 3
Transthoracic Echocardiography, MUGA Scan
Treatment Dispensed and Returned
Treatment Dispensed and Returned - Combination Drug
Unplanned Healthcare Visits for Heart Failure 
Urine Protein 1
Urine Protein 2
VAS for Itching and Quality of Life

Education