ADaM defines dataset and metadata standards that support:
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.
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:
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:
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.
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 Validation Checks v1.3 correspond to the ADaMIG v1.0, Adverse Events (ADAE), and Basic Data Structure for Time-to-Event Analyses (BDS-TTE). All changes and updates are described in Appendix A. Some checks have been reworded for clarification. 75 new checks regarding ADAE and BDS-TTE have been added.
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.
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.
ARM v1.0 for Define-XML v2 supports the submission of ARM as defined in ADaM v2.1. The release package consists of a zip file that includes a readme file, the specification document, an ADaM-based Define-XML example and the ARM schema. Please refer to the readme file for further details.
|ARM v1.0 for Define-XML v2||1.36 MB|
|ARM v1.0 for Define-XML v2.0 Public Review Comments||32.33 KB|
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).