Definitions

ADaM – CDISC Analysis Data Model

ADaM Basic Data Structure (BDS) – A dataset structure designed to facilitate ease of analysis and review, organized as one or more records per subject per analysis parameter per analysis timepoint. Analysis timepoint is conditionally required, depending on the analysis. The BDS, described in the ADaMIG, supports the majority of analyses.

ADaM Implementation Guide (ADaMIG) – A document that specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues. The ADaM document and the ADaMIG should be used together.

Analysis Datasets – Datasets used for statistical analysis and reporting.


Analysis Parameter (PARAM) – A row identifier used to uniquely characterize a group of values that share a common definition. Example: The primary efficacy analysis parameter is “3-Minute Sitting Systolic Blood Pressure (mmHg).” Note that the ADaM analysis parameter contains all of the information needed to uniquely identify a group of related analysis values. In contrast, the SDTM TEST column may need to be combined with qualifier columns such as POS, LOC, SPEC, etc., in order to identify a group of related values. In this document the word “parameter” is used as a synonym for “analysis parameter.”

Analysis Parameter Value-Level Metadata – Information that describes an analysis value within a given analysis parameter or set of analysis parameters.

Analysis Results Metadata – Information that describes a specified analysis result contained within a clinical study report or submission.

Analysis Timepoint – A row identifier used to classify values within an analysis parameter into temporal or conceptual groups used for analyses. These groupings may be observed, planned or derived. Example: The primary efficacy analysis was performed at the Week 2, Week 6, and Endpoint analysis timepoints.

Analysis Value – (1) The character (AVALC) or numeric (AVAL) value described by the analysis parameter. The analysis value may be present in the input data, a categorization of an input data value, or derived. Example: The analysis value of the parameter “Average Heart Rate (bpm)” was derived as the average of the three heart rate values measured at each visit. (2) In addition, values of certain functions are considered to be analysis values. Examples: baseline value (BASE), change from baseline (CHG).


Define File – As stated in the Case Report Tabulation Data Definition Specification[2], the 1999 FDA electronic submission (eSub) guidance and the electronic Common Technical Document (eCTD) documents specify that a document describing the content and structure of the included data should be provided within a submission. This document is known as the Data Definition Document (e.g., “define.pdf” in the 1999 guidance). The Data Definition Document provides a list of the datasets included in the submission along with a detailed description of the contents of each dataset (i.e., metadata). To increase the level of automation and improve the efficiency of the Regulatory Review process, define.xml can be used to provide the Data Definition Document in a machine-readable format. The formal name for this is the Case Report Tabulation Data Definition (CRT DD) specification. Both SDTM and ADaM datasets have their respective Define files.

Metadata – Information or data about data.

Record – A row in a dataset.

SDTM - Study Data Tabulation Model – A document written by the CDISC Submission Data Standards (SDS) team that describes the general conceptual model for representing clinical study data that are submitted to regulatory authorities. The SDTM provides a general framework for describing the organization of information collected for clinical trials and submitted to regulatory authorities