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PharmaSUG2016 Paper SS08 A SAS Macro Tool to Automate Generation of Define.xml V2.0 from DTM Specification for FDA Submission Min Chen, Aldermen Inc., Waltham, MA Changchun (Bob) Coo, Aldermen Inc.,

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How to fill out a cost-effective sdtm conversion

01

Understand the SDTM standards and guidelines.

02

Identify the source data that needs to be converted into SDTM format.

03

Clean and preprocess the source data to ensure data quality and consistency.

04

Map the variables from the source data to the appropriate SDTM domains and variables.

05

Convert the data values to follow the SDTM specifications and formatting rules.

06

Validate the converted data to ensure compliance with SDTM standards.

07

Generate SDTM datasets and submission-ready documentation.

08

Review and validate the final SDTM conversion for accuracy and completeness.

Who needs a cost-effective sdtm conversion?

01

Pharmaceutical companies conducting clinical trials.

02

Contract research organizations (CROs) responsible for data management.

03

Regulatory agencies requesting SDTM format for data submissions.

04

Statistician and biostatisticians analyzing clinical trial data.

05

Data managers and clinical research professionals involved in data processing.

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What is a cost-effective sdtm conversion?

A cost-effective SDTM conversion is the process of converting non-standard clinical data into Study Data Tabulation Model (SDTM) format in a cost-efficient manner.

Who is required to file a cost-effective sdtm conversion?

Any organization or individual conducting clinical trials and using SDTM for data submission is required to file a cost-effective SDTM conversion.

How to fill out a cost-effective sdtm conversion?

To fill out a cost-effective SDTM conversion, one must follow the established SDTM guidelines for mapping and converting the data into the standardized format.

What is the purpose of a cost-effective sdtm conversion?

The purpose of a cost-effective SDTM conversion is to ensure that clinical trial data is submitted in a standardized format that is compatible with regulatory authorities and promotes data interchange.

What information must be reported on a cost-effective sdtm conversion?

A cost-effective SDTM conversion must include all relevant clinical trial data, metadata, and annotations in accordance with SDTM standards.

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