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Pharmacy China 2018 Paper 79My Understandings to DTM and Adam Chunking Zhao, BoehringerIngelheim, Shanghai, China ABSTRACT Why are some diseases mapped into MH or AE, but others into CE? When we annotate
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How to fill out my understandings to sdtm
How to fill out my understandings to sdtm
01
Review the SDTM Implementation Guide to understand the structure and requirements of SDTM.
02
Familiarize yourself with the variable mappings and conventions used in SDTM.
03
Identify the source data elements that need to be converted into SDTM variables.
04
Map the source data elements to their corresponding SDTM variables according to the conventions.
05
Ensure the data values are formatted correctly and meet the SDTM specifications.
06
Validate the SDTM dataset for completeness and accuracy using appropriate tools.
07
Generate the necessary documentation, such as annotated CRFs and define.xml, to accompany the SDTM dataset.
08
Submit the completed SDTM dataset to the appropriate regulatory authorities or stakeholders, if required.
Who needs my understandings to sdtm?
01
Clinical researchers and data managers involved in clinical trials.
02
Pharmaceutical companies and biotech organizations conducting clinical research.
03
Regulatory agencies responsible for reviewing and analyzing clinical trial data for drug approval.
04
Data scientists and statisticians analyzing clinical trial data.
05
Clinical data vendors and contract research organizations (CROs) providing data management services.
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What is my understandings to sdtm?
SDTM stands for Standard Data Tabulation Model, it is a standard format for organizing and formatting data collected during clinical trials.
Who is required to file my understandings to sdtm?
The sponsor of the clinical trial is required to file the understandings to SDTM.
How to fill out my understandings to sdtm?
My understandings should be filled out according to the CDISC standards and guidelines.
What is the purpose of my understandings to sdtm?
The purpose of filing my understandings to SDTM is to ensure that clinical trial data is organized, standardized, and easily shareable for analysis and regulatory submissions.
What information must be reported on my understandings to sdtm?
All relevant data collected during the clinical trial, including demographic information, adverse events, laboratory results, and efficacy outcomes, must be reported on my understandings to SDTM.
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