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Core variables is the compliance with SDTM-IG domain model. It reflects the importance of the overall domain structure. Core variables are 3 types

  1. Required core variable
  2. Expected Core variable
  3. Permissible core variable

1.Required core Variable———- it is used to identify a data record, useful to make a record easily understood. This variable must be included in the dataset and can not be left blank or null. If required core variables are missing in the original data, let it be inform to CDM staff.

Example- Studyid/subjid/siteid.

2.Expected Core Variable——- this type of variables must be included in the dataset but they can be null in some record, if no data is present in the dataset, you can put comment why its happened.

Expected core variable are needed to make record useful within specific domain.

3.Permissible core variable—-This kind of variable must be included in the dataset if results are collected or derived but they can be left blank or null.

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