ADaM defines dataset and metadata standards that support:

  • efficient generation, replication, and review of clinical trial statistical analyses, and
  • traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.


ADaM Implementation Guide v1.2 Release Package

1.2 Release Package
Release Date: 3 Oct 2019

To help the clinical research community implement ADaM, CDISC has posted the ADaMIG v1.2 Release Package, which includes the following documents associated with that release:

  • ADaM v2.1 (17-Dec-2009)
  • Important Considerations When Using ADaM v2.1 (03-Oct-2019)
  • ADaMIG v1.2 (03-Oct-2019)
  • ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses v1.0 (08-May-2012)
  • ADaM Structure for Occurrence Data (OCCDS) v1.0 (12-Feb-2016)
  • ADaM Examples in Commonly Used Statistical Analysis Methods (16-Dec-2011)
  • ADaM Conformance Rules v2.0 (01-Mar-2019)
  • Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (30-Jan-2015)

AttachmentSize
Package icon ADaM_IGv1.2_package.zip7.2 MB

ADaM Implementation Guide v1.1 Release Package

v1.1 Release Package
Release Date: 10 Feb 2016

To help the clinical research community implement ADaM, CDISC has posted the ADaMIG v1.1 Release Package, which includes the following documents associated with that release:

  • ADaM v2.1 (17-Dec-2009)
  • ADaMIG v1.1 (12-Feb-2016)
  • ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses v1.0 (08-May-2012)
  • ADaM Structure for Occurrence Data (OCCDS) v1.0 (12-Feb-2016)
  • ADaM Examples in Commonly Used Statistical Analysis Methods (16-Dec-2011)
  • ADaM Conformance Rules v2.0 (01-Mar-2019)
  • Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (30-Jan-2015)
  • Important Considerations When Using ADaM v2.1 (03-Oct-2019)

AttachmentSize
Package icon ADaM_IGv1.1_package.zip7.03 MB

ADaM Implementation Guide v1.0 Release Package

v1.0 Release Package
Release Date: 17 Dec 2009

To help the clinical research community implement ADaM, CDISC has posted the ADaMIG v1.0 Release Package, which includes the following documents associated with that release:

  • ADaM v2.1 (17-Dec-2009)
  • ADaMIG v1.0  (17-Dec-2009)
  • ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses v1.0 (08- May-2012)
  • CDISC ADaM Structure for Adverse Event Analyses (10-May-2012)
  • ADaM Examples in Commonly Used Statistical Analysis Methods (16-Dec-2011)
  • ADaM Conformance Rules v2.0 (01-Mar-2019)
  • Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (30-Jan-2015)
  • Important Considerations When Using ADaM v2.1 (03-Oct-2019)

AttachmentSize
Package icon ADaM_IGv1.0_package.zip6.33 MB

ADaMIG v1.2

1.2
Release Date: 3 Oct 2019

Version 1.2 of the Analysis Data Model Implementation Guide (ADaMIG v 1.2) updates ADaMG v1.1 with clarifications, corrections, new variables, additional examples, and references to current documents. ADaMIG v 1.2 is intended to guide the organization, structure, and format of analysis datasets and related metadata. It specifies ADaM standard dataset structures and variables, including naming conventions, and presents standard solutions to implementation issues, illustrated with examples. The ADaMIG must be used in close concert with the ADaM v2.1.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.


ADaM Conformance Rules 2.0

2.0
Release Date: 1 Mar 2019

Analysis Data Model (ADaM) specifies the fundamental principles and standards to follow in the creation of analysis datasets and associated metadata. The ADaM Implementation Guide versions 1.0 and 1.1, and the ADaM Structure for Occurrence Data include specific guidelines and rules for defining and creating ADaM datasets. A subset of these rules has been provided as version 2.0 of the ADaM Conformance Rules for the purpose of enabling development of software to perform ADaM dataset checks.

These rules are intended to be used for single studies. They are not meant to define the full spectrum of ADaM compliance as they cannot evaluate the content of ADaM datasets vs. external systems to ensure, for example, that all observed and derived rows for a given analysis parameter are included. The 350+ rules included in this publication can help to ensure that the ADaM datasets have been constructed in a manner that is consistent with the relevant ADaMIG.

A complete assessment of compliance must be based on an understanding of the scope of the study data and the analyses the datasets support in addition to the published conformance rules and the general rules and principles outlined in the ADaMIG.


ADaM v2.1

2.1
Release Date: 17 Dec 2009

ADaM v2.1 explains the purpose of ADaM and how it can be used to support efficient generation, replication, and review of analysis results. The document describes fundamental principles that apply to all analysis datasets, with the driving principle being that the design of analysis datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of, submitted analysis datasets. It also describes ADaM metadata, the subject-level analysis dataset (ADSL) and the Basic Data Structure (BDS). Downloading ADaM v2.1 includes a one-page document titled "Important Considerations When Using ADaM v2.1".

ARM v1.0 for Define-XML v2.0 supports the submission of Analysis Results Metadata (ARM) as defined in ADaM v2.1.

 


AttachmentSize
Package icon ADaM_v2.1.zip1.01 MB

ADaM Implementation Guide v1.1

1.1
Release Date: 12 Feb 2016

ADaMIG v 1.1 updates Version 1.0 with clarifications, corrections, new variables, additional examples, and references to current documents. It is intended to guide the organization, structure, and format of analysis datasets and related metadata. ADaMIG v 1.1 specifies ADaM standard dataset structures and variables, including naming conventions, and presents standard solutions to implementation issues, illustrated with examples. The ADaMIG must be used in close concert with the ADaM document v2.1.


AttachmentSize
PDF icon ADaMIG v1.11.36 MB
File ADaMIG v1.1 Public Review Comments55.27 KB

ADaMIG v1.0

1.0
Release Date: 17 Dec 2009

ADaMIG v1.0 specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues. The ADaMIG must be used in close concert with ADaM v2.1


AttachmentSize
PDF icon ADaMIG_v1.0.pdf1.3 MB