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DM 06Using DISC Lab Terminology and Determining Standard Units
Mat Davis, Omnivore Clinical Research, King of Prussia, PA
ABSTRACT
In any clinical trial submission, laboratory test results are always
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How to fill out using cdisc lab terminology
How to fill out using CDISC lab terminology:
01
Familiarize yourself with the CDISC lab terminology standards and guidelines. This will help you understand the specific terms and codes used in CDISC lab data.
02
Ensure that you have access to the necessary resources and tools for capturing and recording lab data using CDISC terminology. This may include electronic data capture (EDC) systems or specific software.
03
Start by properly identifying the lab test being performed. Use the appropriate CDISC lab terminology code for the test. This code will categorize the test and provide standardized labeling for easier data analysis and comparison.
04
Record the specific lab results accurately using CDISC lab terminology codes. Each result should be labeled and coded according to CDISC standards. This will ensure consistency and enable data integration across different clinical trials and studies.
05
Include any additional relevant information or metadata required by CDISC lab terminology. This may include factors such as the date of the lab test, the reference ranges, and any flags or qualifiers associated with the results.
06
Review the completed lab data to ensure accuracy and consistency. Double-check that the CDISC lab terminology codes and labels have been appropriately applied. This will help minimize errors and ensure compatibility with other CDISC-compliant datasets.
07
Share the CDISC lab data and terminology with relevant stakeholders, such as regulatory bodies, sponsors, or other researchers. This will facilitate data exchange and improve overall understanding and analysis of the lab results.
Who needs using CDISC lab terminology?
01
Clinical researchers and scientists who conduct clinical trials and studies that require lab data.
02
Regulatory authorities that review and evaluate pharmaceutical or medical device submissions. CDISC lab terminology ensures standardized data representation and facilitates the regulatory review process.
03
Data analysts and statisticians who analyze and interpret lab data. Using CDISC lab terminology allows for more efficient data analysis and integration across various studies and datasets.
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What is using cdisc lab terminology?
CDISC lab terminology is used to standardize the representation of laboratory data in clinical trials.
Who is required to file using cdisc lab terminology?
All organizations conducting clinical trials are required to use CDISC lab terminology.
How to fill out using cdisc lab terminology?
CDISC lab terminology should be filled out according to the specific guidelines and standards provided by CDISC.
What is the purpose of using cdisc lab terminology?
The purpose of using CDISC lab terminology is to improve data accuracy, consistency, and interoperability in clinical research.
What information must be reported on using cdisc lab terminology?
All laboratory data collected during a clinical trial must be reported using CDISC lab terminology.
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