Standards
NoteStandards used in this portfolio (ADaM)
This page documents the current released CDISC ADaM standards used to build the ADaM examples in this portfolio.
These versions align with the example datasets, specs, and metadata snapshots included in this repo.
Core ADaM standards (current released)
| Standard / Artifact | Latest released version | Published | Why it matters |
|---|---|---|---|
| ADaM (Model) | v2.1 | 2009-12-07 | Foundational ADaM principles and model concepts |
| ADaMIG (Human Clinical Trials) | v1.3 | 2021-11-29 | Core analysis dataset structures/variables (ADSL, BDS) |
| ADaM Conformance Rules | v5.0 | 2023-10-06 | Validation rule set used by conformance tools |
| ADaM Metadata Submission Guidelines (ADaM-MSG) | v1.0 | 2023-04-18 | Guidance for the eCTD Module 5 “adam” folder/package |
| ADaM Controlled Terminology (NCI EVS) | 2025-09-26 | 2025-09-26 | Terminology package date used for codelists/values |
Companion ADaM implementation guides (commonly used)
| Companion IG | Version | Published | Typical use |
|---|---|---|---|
| Occurrence Data Structure (OCCDS) IG | v1.1 | 2021-11-29 | Occurrence-style analyses (AE/CM/MH-like structures) |
| NCA Input Data (ADNCA) IG | v1.0 | 2021-11-29 | PK non-compartmental analysis inputs |
| Medical Devices (ADaMIG-MD) IG | v1.0 | 2021-11-29 | Medical device analysis structures |
| BDS for Time-to-Event (TTE) Analyses | v1.0 | 2016-02-12 | Time-to-event endpoints and censoring conventions |
| BDS for popPK IG | v1.0 | 2023-10-06 | BDS extensions for population PK |
High-signal examples (what reviewers love)
| Examples document | Version | Published | Why it’s useful |
|---|---|---|---|
| ADaM Examples of Traceability | v1.0 | 2022-05-12 | Shows end-to-end traceability patterns (SDTM → ADaM → results) |
| ADaM Oncology Examples | v1.0 | 2025-06-10 | Oncology-focused analysis approaches using ADaM structures |
Official references (source of truth)
- ADaM v2.1 — https://www.cdisc.org/standards/foundational/adam/adam-v2-1
- ADaMIG v1.3 — https://www.cdisc.org/standards/foundational/adam/adamig-v1-3
- ADaM Conformance Rules v5.0 — https://www.cdisc.org/standards/foundational/adam/adam-conformance-rules-v5-0
- ADaM-MSG v1.0 — https://www.cdisc.org/standards/foundational/adam/adam-metadata-submission-guidelines-v1-0
- ADaM OCCDS IG v1.1 — https://www.cdisc.org/standards/foundational/adam/adam-structure-occurrence-data-implementation-guide-v1-1
- ADNCA v1.0 — https://www.cdisc.org/standards/foundational/adam/adamig-non-compartmental-analysis-input-data-v1-0
- ADaMIG-MD v1.0 — https://www.cdisc.org/standards/foundational/adam-medical-devices/adamig-medical-devices-v1-0
- BDS for TTE Analyses v1.0 — https://www.cdisc.org/standards/foundational/adam/adam-basic-data-structure-bds-time-event-tte-analyses-v1-0
- BDS for popPK IG v1.0 — https://www.cdisc.org/standards/foundational/adam/basic-data-structure-adam-poppk-implementation-guide-v1-0
- ADaM Examples of Traceability v1.0 — https://www.cdisc.org/standards/foundational/adam/adam-examples-traceability-v1-0
- ADaM Oncology Examples v1.0 — https://www.cdisc.org/standards/foundational/adam/adam-oncology-examples-v1-0-0
- Controlled Terminology landing page — https://www.cdisc.org/standards/terminology/controlled-terminology
- NCI EVS ADaM terminology downloads — https://evs.nci.nih.gov/ftp1/CDISC/ADaM/
Portfolio conventions (how these are applied)
- Baseline: ADaM examples assume ADaM v2.1 + ADaMIG v1.3.
- Validation: conformance checks reference ADaM Conformance Rules v5.0 where applicable.
- Terminology: values align to the CT package date listed above.
- Submission awareness: always confirm required versions per sponsor/regulatory expectations.
TipMaintenance note
Controlled Terminology updates more frequently than ADaM/ADaMIG.
When CT updates, change the CT date in the table (and optionally add a changelog entry).
Last updated: 2026-02-14