CDISC ADaM standard

ADaM is a CDISC standard to submit analysis data to FDA. Key is to understand that ADaM is a SDTM model for providing analysis data, programs and data definitions. The principles of ADaM is aimed at providing  a clear and unambiguous  communicationof the content, source and  quality of the datasets submitted in support of  the statistical analysis performed by the 
sponsor. This in turn would support the machine-readable  description for the JANUS data repository. 

Analysis datasets

Analysis datasets are datasets created to support specific analyses.

• Each dataset is provided as a SAS Transport (XPORT) file. 
• Programs should be provided as both ASCII text and PDF files and should include sufficient documentation to allow a reviewer to understand the submitted programs. 

Programs

Programs are scripts used with selected software to produce reported analyses based on these datasets.

Analysis-level Metadata

• ANALYSIS NAME –A unique identifier for this analysis. May include a table number or other sponsor- specific reference. 
• DOCUMENTATION –A text description documenting the analysis performed.
• REASON –The reason for performing this analysis. Examples may include Pre-specified, Data-driven, Exploratory, and Regulatory Request. 
• DATASET –the name of the analysis dataset used should be linked to the analysis dataset used for this analysis. In most cases, this will be a single dataset. If multiple datasets are used, they should all be listed here. 
• PROGRAM –Analysis programs using the DATASET above as input can be described or included here.

The complete ADaM specification can be found at : http://www.cdisc.org/models/adam/V2.0/index.html