Get the free CDISC SDTM Controlled Terminology - NCI EVS - msun

KNM Radio Committee Meeting Minutes 1 Meeting Logistics Item Date 9/26/2014 Time 9:00 a.m. Location Library Conference RoomDescription2 Attendees Role Name Facilitators Chair: Spike Magellan & Vice

How to fill out cdisc sdtm controlled terminology

How to fill out CDISC SDTM controlled terminology:

1. Understand the purpose of CDISC SDTM controlled terminology: CDISC SDTM (Study Data Tabulation Model) controlled terminology is a standardized vocabulary used in clinical research to ensure consistency in data collection, storage, and analysis. It provides a set of predefined terms that researchers can use to classify various elements of clinical trial data.
2. Familiarize yourself with the CDISC SDTM Terminology: Before filling out CDISC SDTM controlled terminology, it is essential to understand the terminology itself. CDISC provides comprehensive documentation and resources explaining the various domains, variables, code lists, and conventions used in SDTM.
3. Determine the relevant domains and variables: CDISC SDTM covers a wide range of domains and variables, such as demographics, adverse events, laboratory tests, and medical history. Review the requirements of your study and identify the specific domains and variables that are applicable.
4. Select the appropriate code lists: CDISC SDTM controlled terminology provides code lists for each domain and variable. These code lists consist of predefined values that researchers can choose from to classify the data. Carefully review the code lists and select the most appropriate codes for your study data.
5. Assign the codes to the corresponding data elements: Once you have selected the appropriate codes from the CDISC SDTM controlled terminology code lists, assign them to the corresponding data elements in your clinical trial dataset. Ensure that the assigned codes accurately represent the collected data.

Who needs CDISC SDTM controlled terminology:

1. Clinical researchers: CDISC SDTM controlled terminology is primarily used by clinical researchers involved in the design, conduct, and analysis of clinical trials. It helps them standardize data collection and ensures compatibility and comparability across different studies.
2. Pharmaceutical industry professionals: Professionals working in the pharmaceutical industry, such as drug developers, regulatory affairs specialists, and statisticians, benefit from CDISC SDTM controlled terminology. It facilitates data integration and analysis for regulatory submissions and post-marketing surveillance.
3. Data managers and analysts: Data managers and analysts involved in clinical research rely on CDISC SDTM controlled terminology to effectively manage and analyze study data. It enables them to harmonize and structure the collected data in a standardized format, ensuring interoperability and consistency.

In conclusion, filling out CDISC SDTM controlled terminology requires a good understanding of the terminology itself, selecting appropriate codes, and assigning them to relevant data elements. It is essential for clinical researchers, pharmaceutical industry professionals, and data managers and analysts in the field of clinical research.

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What is cdisc sdtm controlled terminology?

CDISC SDTM Controlled Terminology is a set of standard terms used for the submission of data in clinical trials.

Who is required to file cdisc sdtm controlled terminology?

All organizations conducting clinical trials and submitting data to regulatory authorities are required to use CDISC SDTM Controlled Terminology.

How to fill out cdisc sdtm controlled terminology?

CDISC SDTM Controlled Terminology can be filled out by selecting the appropriate standard terms from the predefined list provided by CDISC.

What is the purpose of cdisc sdtm controlled terminology?

The purpose of CDISC SDTM Controlled Terminology is to ensure consistency and accuracy in the submission of clinical trial data.

What information must be reported on cdisc sdtm controlled terminology?

CDISC SDTM Controlled Terminology requires the reporting of standard terms for variables such as laboratory tests, adverse events, and medical history.