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USE DISCS DTM AS A DATA MIDDLE-TIER TO STREAMLINE YOUR SAS INFRASTRUCTURE Kalyan Chilukuri, Lenovo, Sunnyvale CA WUSS 2011 Annual Conference October 2011 TABLE OF CONTENTS 1. ABSTRACT ...........................................................................................................................
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How to fill out use cdisc sdtm as
How to fill out use CDISC SDTM (Study Data Tabulation Model) as:
01
Start by understanding the purpose and structure of SDTM. SDTM is a standard for organizing and formatting clinical trial data to facilitate data sharing and analysis. Familiarize yourself with the CDISC SDTM implementation guide and the specific domains and variables required for your study.
02
Ensure the availability of necessary documentation. Gather the protocol, case report forms (CRFs), and any data management plan related to the study. Reviewing these documents will help you understand the data collection requirements and identify the variables to be included in SDTM.
03
Begin mapping the data elements to the SDTM domains. This involves identifying the relevant variables in the collected data and mapping them to the corresponding SDTM domains and variables. CDISC provides standard Controlled Terminology (CT) for mapping purposes. Use appropriate tools or software that support SDTM mapping, such as SAS or OpenCDISC.
04
Validate the mapped data. Verify the accuracy and completeness of the mapped variables. Check for any missing or inconsistent data. Ensure that all necessary variables are included, and there are no extra variables that do not belong to SDTM.
05
Transform the data into SDTM format. Once the mapping is validated, transform the data into the SDTM format using the specified naming conventions, variable formats, and structure. Follow CDISC guidelines for standards such as date formats, null values, and controlled terminology.
06
Conduct quality checks and review the SDTM datasets. Perform thorough quality checks on the transformed datasets to ensure data integrity. Review the datasets for any discrepancies or errors. Validate the data against CDISC SDTM validation rules and any other specific requirements from regulatory authorities or sponsors.
07
Submit the SDTM datasets. Once the SDTM datasets are finalized and validated, prepare them for submission. Ensure that all required documentation, such as define.xml files, are included. Follow the submission guidelines provided by the regulatory authorities or sponsors.
Who needs use CDISC SDTM as:
01
Clinical trial researchers and sponsors: CDISC SDTM is essential for researchers and sponsors conducting clinical trials as it provides a standardized structure for organizing and analyzing data. It ensures that data can be shared, integrated, and analyzed efficiently, promoting transparency and reproducibility in clinical research.
02
Regulatory authorities: Regulatory authorities, such as the FDA or EMA, require the submission of clinical trial data in SDTM format. SDTM facilitates the review and analysis of trial data by these authorities, enabling them to make informed decisions during the drug approval process.
03
Data managers and statisticians: CDISC SDTM simplifies data management and analysis processes for data managers and statisticians. It provides a consistent framework for organizing and analyzing data, saving time and effort in data integration and analysis.
04
Organizations involved in data sharing and research collaborations: SDTM enables seamless data sharing and collaboration between different organizations involved in clinical research. By adopting SDTM, organizations can easily integrate data from multiple studies or sources, supporting meta-analyses and pooled analyses.
In conclusion, filling out and using CDISC SDTM is crucial for various stakeholders involved in clinical research, ensuring standardized data organization, easier data sharing, and optimized data analysis.
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What is use cdisc sdtm as?
SDTM (Study Data Tabulation Model) is used as a standard for organizing and formatting clinical trial data.
Who is required to file use cdisc sdtm as?
Sponsors and researchers conducting clinical trials are required to use CDISC SDTM for submission of data to regulatory authorities.
How to fill out use cdisc sdtm as?
CDISC SDTM can be filled out using specialized software tools that support the standard format and guidelines provided by CDISC.
What is the purpose of use cdisc sdtm as?
The purpose of CDISC SDTM is to ensure consistency, traceability, and interoperability of clinical trial data for regulatory submissions.
What information must be reported on use cdisc sdtm as?
CDISC SDTM requires specific datasets including clinical, laboratory, and adverse event data from clinical trials.
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