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 v1.1 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)

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)

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

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 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

ADaM Structure for Occurrence Data (OCCDS) v1.0

1.0
Release Date: 16 Feb 2016

ADaM OCCDS v1.0 is based on ADaM Version 2.1 and the ADaMIG v1.1. It is built on the nomenclature of the Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 standard for collected data, and features added content required for statistical analyses, including metadata defined for the OCCDS. ADaM OCCDS v1.0 includes several examples with displays, data, and associated metadata applied to adverse events, concomitant medications, and medical history.


ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses v1.0

1.0
Release Date: 8 May 2012

ADaM BDS for TTE Analyses v1.0 provides definitions and examples of BDS datasets, variables, and metadata that support time-to-event analyses. The document addresses three scenarios 1) A Single Endpoint with a Binary Value for Censoring, 2) A Single Endpoint with Multiple Values for Censoring, and 3) Composite Endpoints. The document also provides descriptions of typical TTE analyses including example outputs and associated results-level metadata, clear step-by-step information about how to create and populate the supportive and analyzed datasets, and variables required for both TTE analysis and traceability.


AttachmentSize
PDF icon ADaM BDS for TTE Analyses v1.0434.43 KB

ADaM Examples in Commonly Used Statistical Analysis Methods

1.0
Release Date: 16 Dec 2011

The ADaM Examples in Commonly Used Statistical Analysis Methods provides examples of the Analysis Data Model applied in statistical methods that are commonly used. The ADaM subject-level analysis dataset (ADSL) and Basic Data Structure (BDS) and the associated metadata are illustrated. Issues and points to consider when building ADaM datasets and metadata are highlighted.


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).

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