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CDISC Standards Overview

Trial Submission Studio supports CDISC (Clinical Data Interchange Standards Consortium) standards for regulatory submissions.

What is CDISC?

CDISC develops global data standards that streamline clinical research and enable connections to healthcare. These standards are required by regulatory agencies including the FDA and PMDA.

Supported Standards

Currently Implemented

StandardVersionStatus
SDTM-IG3.4Supported
Controlled Terminology2024-2025Supported

Planned Support

StandardVersionStatus
ADaM-IG1.3Planned
SEND-IG3.1.1Planned

SDTM (Study Data Tabulation Model)

SDTM is the standard structure for submitting study data to regulatory authorities.

Key Concepts

  • Domains: Logical groupings of data (e.g., Demographics, Adverse Events)
  • Variables: Individual data elements within domains
  • Controlled Terminology: Standardized values for specific variables

Learn More

Controlled Terminology

CDISC Controlled Terminology (CT) provides standardized values for SDTM variables.

Embedded Versions

Trial Submission Studio includes the following CT packages:

  • CDISC CT 2025-09-26 (latest)
  • CDISC CT 2025-03-28
  • CDISC CT 2024-03-29

Learn More

ADaM (Analysis Data Model)

ADaM is the standard for analysis-ready datasets derived from SDTM.

Note

ADaM support is planned for a future release.

SEND (Standard for Exchange of Nonclinical Data)

SEND is SDTM for nonclinical (animal) studies.

Note

SEND support is planned for a future release.

FDA Requirements

Electronic Submissions

The FDA requires CDISC standards for:

  • New Drug Applications (NDA)
  • Biologics License Applications (BLA)
  • Abbreviated New Drug Applications (ANDA)

Study Data Technical Conformance Guide

Trial Submission Studio aligns with FDA’s Study Data Technical Conformance Guide requirements:

  • XPT V5 format
  • Define-XML 2.1
  • Controlled Terminology validation

Resources

Official CDISC Resources

FDA Resources

Next Steps