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Pharmacy 2014 PO14 Route DTM Implementation in Invited Diagnostic Industry: Simple or Twisted Carey Smock, Roche Molecular Systems, Inc., Pleasant on, CA Sofia Shaman, Maxis IT Inc., NJ Chordata Chaitanya,
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How to fill out route to sdtm implementation
How to fill out route to sdtm implementation:
01
Evaluate the study protocol and identify the variables that need to be mapped to SDTM domains.
02
Define the mapping rules and conventions for converting the source data to SDTM format.
03
Map the variables from the source data to the appropriate SDTM datasets and domains.
04
Validate the mapping by comparing the generated SDTM datasets with the source data.
05
Review the annotations and documentation to ensure clarity and consistency in the implementation process.
06
Prepare the final SDTM datasets for submission to regulatory authorities.
Who needs route to sdtm implementation:
01
Pharmaceutical companies conducting clinical trials and submitting data to regulatory authorities.
02
Data managers and statisticians involved in the data conversion process.
03
Regulatory bodies and authorities requesting SDTM-compliant data for review and analysis.
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What is route to SDTM implementation?
Route to SDTM implementation is the process of transforming clinical trial data into CDISC SDTM format.
Who is required to file route to SDTM implementation?
Biopharmaceutical companies conducting clinical trials are required to file route to SDTM implementation.
How to fill out route to SDTM implementation?
Route to SDTM implementation is typically filled out using software tools that support CDISC standards and guidelines.
What is the purpose of route to SDTM implementation?
The purpose of route to SDTM implementation is to ensure that clinical trial data is standardized and can be easily shared and analyzed.
What information must be reported on route to SDTM implementation?
Route to SDTM implementation must include detailed information about the clinical trial data structure, variables, and mappings to SDTM domains.
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