Get the free Cdisc Protocol Controlled Terminology, 2020-09-25
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This document provides a structured terminology and value sets relevant to clinical study attributes, trial phases, participant allocation, and other terminological standards used in clinical trials
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How to fill out cdisc protocol controlled terminology
How to fill out cdisc protocol controlled terminology
01
Review the CDISC standards relevant to your study.
02
Identify the required terminology from the CDISC controlled terminology list.
03
Access the latest version of the controlled terminology which can be found on the CDISC website.
04
Select the appropriate terms that align with your study objectives and dataset requirements.
05
Ensure that the terms are accurately incorporated into your study protocol.
06
Validate the terms with cross-references to ensure they meet regulatory requirements.
Who needs cdisc protocol controlled terminology?
01
Clinical trial sponsors.
02
Data managers and statistical programmers.
03
Regulatory submissions teams.
04
Clinical researchers and investigators.
05
Biostatisticians.
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What is CDISC protocol controlled terminology?
CDISC protocol controlled terminology refers to a standardized set of terms and definitions used in clinical research to ensure consistency in data collection, analysis, and reporting.
Who is required to file CDISC protocol controlled terminology?
Organizations involved in clinical trials and submitting data to regulatory authorities, such as pharmaceutical companies and clinical research organizations, are required to file CDISC protocol controlled terminology.
How to fill out CDISC protocol controlled terminology?
To fill out CDISC protocol controlled terminology, one should use the standardized terms provided by CDISC, ensure that the chosen terms align with the protocol requirements, and document any deviations or custom terms where necessary.
What is the purpose of CDISC protocol controlled terminology?
The purpose of CDISC protocol controlled terminology is to enhance data interoperability and communication across different systems, ensuring that data is accurately interpreted and reducing discrepancies in clinical trial reporting.
What information must be reported on CDISC protocol controlled terminology?
Information that must be reported on CDISC protocol controlled terminology includes the definitions of terms used in the study, the version of the terminology, and any mappings or relationships between terms relevant to the study protocol.
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