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Summary

This article is intended to provide details related to mapping of CRF data in XPT, CSV, and Excel transfer style exports - addressing variable setup in ClinSpark and reporting of those variables. In this article, “Base Fields” refer to variables that are fully or partially intrinsic to the ClinSpark application and not fully modifiable by site users.  “Custom Fields” refer to variables that are based on study design and therefore entirely modifiable by site users.

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It is possible to change the format of dates and times in transfer reports, but this needs to be done by IQVIA support staff via request on the service desk and may incur a fee.

Randomized Subjects

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When generating the report, this option will narrow output to subjects that have obtained a randomization number. However, if subjects are also defined as part of the report input prior to generating, this setting will be ignored.

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Transfer Data Mapping (Base Fields)

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For more information regarding Repeating Item Groups, please refer to the the following Knowledge Base Articles:

Repeating Item Groups Knowledge Base Article

Default Item Groupings Knowledge Base ArticleGroups

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Clinical Data XPT

Item Group repeat numbers map within every dataset under a “[domain]REPEAT” variable when reported via a Clinical Data XPT Transfer report.

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