CDISC standards applicable to data collection, tabulation, and analysis for each use case category are summarized in the table below.
| Category | Data Collection Standard | Data Tabulation Standard | Data Analysis |
|---|---|---|---|
| Product Description | NA | ||
| Nonclinical | |||
| Product Impact on Individual Health | |||
| Product Impact on Population Health |
CDASH standards for collection, SEND and SDTM standards for data tabulation, and ADaM standards for creation of analysis datasets organize data ...
Aside from a limited number of special-purpose domains, all subject-level SDTM datasets are based on 1 of the 3 general observation classes. When faced with a set of data that were collected and that "go together" in some sense, the first step is to identify SDTM observations within the data and the general observation class of each observation. Once these observations are identified at a high level, 2 other tasks remain:
- Determining whether the relationships between these observations need to be represented using GRPID within a dataset, as described in Section 8.1, (SENDIG v3.1.1) Relating Groups of Records Within a Domain Using the --GRPID Variable, or using RELREC between datasets, as described in Section 8.3, (SENDIG v3.1.1) Supplemental Qualifiers - SUPP-- Datasets
- Placing all the data items in 1 of the identified general observation class records, or in a SUPP-- dataset, as described in Section 8.5, (SENDIG v3.1.1) Relating Findings To Multiple Subjects - Subject Pooling
In practice, considering the representation of relationships and placing individual data items may lead to reconsidering the identification of observations, so the whole process may require several iterations.
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