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Analysis dataset metadata provide information about the analysis dataset, including a description of the contents of the dataset. Best practices strongly recommend that every analysis dataset be described using the metadata fields desribed below. ADD FIELDS

Analysis Dataset Metadata Field

Description

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.

DATASET DESCRIPTION

A short descriptive summary of the contents of the dataset

DATASET LOCATION

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

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”).

KEY VARIABLES OF DATASET

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

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

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.

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