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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The behaviour of the Transfer Report can be adjusted through both system level and study level configuration options.
System level configuration is managed through the use of a Global Setting (In Administration > General Settings) with a key of “TransferReportSettings”.
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The setting value is controlled by superadmin users; changes must be submitted through the service desk so support team members can modify it. However, non-superadmin users who have access to the System Settings component can view the current setting value at any time by accessing the hyperlink next to MD5 checksum.
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The setting file provided will have the extension .globalsetting which can be opened by any standard text editor (such as Notepad).
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The setting value is in “JSON” format - a simple data-interchange format that uses human-readable text to store information.
System level settings can be overridden at the study level through the use of study aliases assigned to an item group. Any item group can be used for storing the settings, but we suggest creating a group named ‘Transfer Report Settings’ to aid easily identifying settings within studies.
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The use of configuration is perhaps best illustrated through examples. Firstly, consider a Global Setting value that configures the Transfer Report to include unique row identifiers and use ‘-’ as a separator between elements of the Unique Subject Id (USUBJID):
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As a general rule, the ‘context’ used for an alias will be ‘TransferReport.’ followed by the setting name used in the Global Setting.
The available settings for both aliases and the global setting are:
Setting Name | Description | Possible values | Default |
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dataWrap | The character to use to wrap data in text files (e.g. CSV files). Normally a quote | Any value |
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delimiter | The delimiter to use when generating text files (e.g. a comma is used for CSV files). | Any value |
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includeUniqueRowId | Determines if the |
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includeUnlockedForms | Allows inclusion of data linked to unlocked forms |
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includeSiteId | Determines if the |
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USUBJIDSeparator | The separator to use between elements of the | Any value |
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USUBJIDSubject | The subject number to use within | See the section on | randomizationScreening |
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