ADaM数据结构分类

ADaM的结构可分为三个:Subject Level Structure 、Occurrence Data Structure和Basic Data Structure。

**Subject Level Structure **:
1.One record per subject, regardless of study design;
2.Contains important information about a subject;
3.Contains required variables with standard names and attributes;
4.Is currently the only required ADaM analysis dataset

Occurrence Data Structure
1.Occurrence analysis is the counting of subjects with a given record or term, and often include a structured hierarchy of dictionary coding categories.(Adverse Events, Concomitant Medications, Medical History)
2.Support summary of frequencies and percentages.
Different ADaM data should be created for different analysis purpose (time to first occurrence of an AE of special interest)
3.Structure
Usually One record per each record in the corresponding SDTM domain.
If multiple coding path is needed, rows would be added for each coding path analyzed.

Basic Data Structure
1.Designed to support majority of analysis methods
2.One or more records per subject per analysis parameter, per analysis time point (if applicable)
3.Includes observations for both observed and derived values required for analysis
4.Variables on the records are focused on the analysis variables, i.e. PARAM / AVAL
5.Allows flexibility to add supportive columns as needed
6.Some analyses methods may require a different structure than BDS:

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