To provide metadata models and examples of analysis datasets used to generate the statistical results for a regulatory submission as well as metadata models and examples covering the statistical results.
Scope
The ADaM Team develops standards for the submission of analysis datasets that support the creation of statistical summaries for clinical trials. The Analysis Data Model (ADaM) assumes that analysis datasets are created primarily from source data compliant with the Study Data Tabulation Model (SDTM). The ADaM is described by two primary documents: the Analysis Data Model (Model Document) and its Implementation Guide (ADaMIG), as well as supportive appendix documents such as ADTTE and OCCDS. ADaM metadata are modeled the same way as SDTM metadata, with an increased emphasis on value-level metadata, plus Analysis Results Metadata. Throughout the ADaM, it is acknowledged that clinical trials are unique, and that the design of analysis datasets is driven by the scientific and medical objectives of the study. Clear communication regarding the analyses which support these objectives is a foundational principle.
The ADaM team intends to continue to support and enhance the Model Document and ADaM-IG and to support the data standardization needs from the FDA and the Therapeutic-area focused initiatives.
Stakeholders/Constituency
Regulatory Authorities
Standards Development Organizations
Pharmaceutical Sponsors
Medical Devices, Diagnostics
Contract Research Organizations & Consultants
Collaborations
The ADaM Team works closely with CDISC Teams, who utilize or leverage the ADaM standard to develop their own IG:
SDTM, Devices, Define
The ADaM Team also has ties to BRIDG, SHARE, and TA Project Teams
The ADaM team also participates in PhUSE initiatives
Operating Model & Meetings
Full team meets every other week on Monday 1:00-2:30 pm US Pacific time
Sub-teams set own meeting schedule, and progress on full team calls