ADaM for Clinical, analysis-ready and traceable
ADaM is the CDISC exchange standard that holds as-collected patient data in a form consistent with the Statistical Analysis Plan. Xbiom™ MDR and Smart Transformer generate compliant SDTM and ADaM datasets with the consistency, reliability and traceability submissions require.
Analysis is a necessary step. ADaM makes it reproducible.
Analysis of clinical trials assesses the efficacy and safety of novel therapeutics. ADaM holds the as-collected patient data in a manner consistent with the rules set out in the Statistical Analysis Plan, playing a pivotal role in statistical analyses, regulatory submissions and reproducible research.
Analysis-ready datasets
ADaM structures as-collected SDTM data into an analysis-ready form, so statistical models, efficacy evaluations and safety analyses run seamlessly. Flags make it easy to run analysis scripts.
Traceability end to end
ADaM datasets link directly to the SDTM datasets and source data, giving a clear audit trail for regulatory compliance and reproducibility.
Regulatory compliance
ADaM is endorsed by regulatory agencies including the FDA in the United States and the PMDA in Japan, keeping data compatible with submission requirements.
A standardized structure
ADaM provides a consistent framework across three dataset structures, so reviewers and statisticians always know where to look.
Three structures, one analysis framework
ADaM organizes analysis data into a small, well-defined set of structures, keeping the number of analysis datasets to the optimum needed to perform the planned analyses.
Subject-Level Analysis Dataset
One record per subject. Holds the demographic and treatment information that anchors every other analysis dataset.
Basic Data Structure
Supports longitudinal and time-to-event analyses, with the parameter and analysis values needed for statistical models.
Occurrence Data Structure
Handles event-based data such as adverse events, concomitant medications and medical history.
From a curated repository to submission-ready ADaM
Analysis datasets are stored in the repository, the Universal Data Model, which is matured into a Data Services Layer of view-ready research data, complete with the metadata that records imputation, end-point derivations and cohort selections.
Curate in the UDM
As-collected data is curated and stored in the Universal Data Model, the repository behind the analysis datasets.
Mature to the Data Services Layer
The UDM matures into view-ready research data, with metadata for imputation, end-point derivations and cohort selections.
Transform to SDTM and ADaM
Xbiom™ MDR and Smart Transformer generate compliant SDTM and ADaM with your selected IG and Controlled Terminology.
Generate artifacts and validate
define.xml, Reviewer’s Guide and ADaM validation rules are produced, then checked with the onboard eDataValidator.
Submission artifacts, validated as you build
As part of the regulatory submission package, Xbiom™ MDR and Smart Transformer also generate the ADaM artifacts: define.xml, the Reviewer’s Guide and ADaM validation rules for CDISC, FDA and PMDA. With the onboard eDataValidator and intelligent automation, Xbiom™ validates the SDTM or ADaM data product across a number of validation cycles to ensure data quality throughout standardization.
ADaM for clinical, answered
What is the Analysis Data Model (ADaM)?+
What is the difference between ADSL, BDS and OCCDS?+
How does ADaM provide traceability?+
Which regulators accept ADaM?+
How does Xbiom generate ADaM?+
How is the ADaM data validated?+
Turn curated study data into submission-ready ADaM
Mature your repository into a Data Services Layer, then generate compliant SDTM and ADaM with define.xml, a Reviewer’s Guide and validation rules, all validated with eDataValidator. See Xbiom™ MDR and Smart Transformer in action.
