Analysis Dataset Metadata

Num

Analysis Dataset Metadata Field

Description

1

DATASET NAME

The file name of the dataset, hyperlinked to the corresponding analysis dataset variable descriptions (i.e., the data definition table) within the define file.

2

DATASET DESCRIPTION

A short descriptive summary of the contents of the dataset

3

DATASET LOCATION

The folder and filename where the dataset can be found, ideally hyperlinked to the actual dataset (i.e., XPT file)

4

DATASET STRUCTURE

The level of detail represented by individual records in the dataset (e.g., “One record per subject,” “One record per subject per visit,” “One record per subject per event”).

5

KEY VARIABLES OF DATASET

A list of variable names that parallels the structure, ideally uniquely identifies and indexes each record in the dataset.

6

CLASS OF DATASET

Identification of the general class of the dataset using the name of the ADaM structure (i.e., “ADSL,” “BDS”) or “OTHER” if not an ADaM-specified structure

7

DOCUMENTATION

Description of the source data, processing steps, and analysis decisions pertaining to the creation of the dataset. Software code of various levels of functionality and complexity, such as pseudo-code or actual code fragments may be provided. Links or references to external documents (e.g., protocol, statistical analysis plan, software code) may be used.