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-Raw Data Structure: Data from different EDC systems come in varying
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structures, with different variable names, dataset names, etc.
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- Raw Data Structure: Data from different EDC systems come in varying
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structures, with different variable names, dataset names, etc.
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-Varying Data Collection Standards: Despite the availability of CDASH
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(Clinical Data Acquisition Standards Harmonization), pharmaceutical
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companies still create different eCRFs using CDASH standards.
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- Varying Data Collection Standards: Despite the availability of CDASH
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(Clinical Data Acquisition Standards Harmonization), pharmaceutical
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companies still create different eCRFs using CDASH standards.
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Due to the differences in raw data structures and data collection
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standards, it may seem impossible to develop a common approach for
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programming SDTM datasets.
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## GOAL
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'sdtm.oak' aims to address this issue by providing an EDC-agnostic,
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‘sdtm.oak’ aims to address this issue by providing an EDC-agnostic,
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standards-agnostic solution. It is an open-source R package that offers
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a framework for the modular programming of SDTM in R. With future
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releases; we plan to develop a code generation feature based on a
@@ -64,7 +58,7 @@ automate the creation of SDTM datasets.
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## Scope
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Our goal is to use 'sdtm.oak' to program most of the domains specified
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Our goal is to use ‘sdtm.oak’ to program most of the domains specified
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in SDTMIG (Study Data Tabulation Model Implementation Guide: Human
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Clinical Trials) and SDTMIG-AP (Study Data Tabulation Model
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Implementation Guide: Associated Persons). This R package is based on
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SDTMIG and across different versions of SDTM IGs. The design of these
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functions allows users to specify a raw dataset and a variable name(s)
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as parameters, making it EDC (Electronic Data Capture) agnostic. As long
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as the raw dataset and variable name(s) exist, 'sdtm.oak' will execute
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as the raw dataset and variable name(s) exist, ‘sdtm.oak’ will execute
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the SDTM mapping using the selected function. It’s important to note
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that 'sdtm.oak' may not handle sponsor-specific details related to
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that ‘sdtm.oak’ may not handle sponsor-specific details related to
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managing metadata for LAB tests, unit conversions, and coding
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information, as many companies have unique business processes.
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## This Release
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With the V0.2.0 release of 'sdtm.oak' users can now efficiently
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create the DM domain and various SDTM domains, encompassing Findings,
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Events, Findings About, and Intervention classes. However, the V0.2.0 release does NOT cover Trial Design Domains, SV (Subject Visits), SE (Subject Elements), RELREC (Related Records), Associated Person domains, or the EPOCH Variable across all domains.
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With the V0.2.0 release of ‘sdtm.oak’ users can now efficiently create
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the DM domain and various SDTM domains, encompassing Findings, Events,
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Findings About, and Intervention classes. However, the V0.2.0 release
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does NOT cover Trial Design Domains, SV (Subject Visits), SE (Subject
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Elements), RELREC (Related Records), Associated Person domains, or the
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EPOCH Variable across all domains.
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## Road Map
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Subsequent Releases: We are planning to develop the below features in
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the subsequent releases.\
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the subsequent releases.
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- Metadata driven code generation based on the standardized SDTM
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specification.\
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- Functions required to program the Domains SV (Subject Visits), SE (Subject Elements) and the EPOCH Variable.\
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- Functions to derive standard units and results based on metadata.
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- Additional features to be developed based on the user feedback.
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specification.
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- Functions required to program the Domains SV (Subject Visits), SE
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(Subject Elements) and the EPOCH Variable.
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- Functions to derive standard units and results based on metadata. -
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Additional features to be developed based on the user feedback.
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