4 Flashcards
What does CDISC stand for?
Clinical Data Interchange Standards Consortium
True or False: CDISC standards are only applicable to clinical trial data.
False
Which CDISC standard is primarily used for the submission of clinical trial data to regulatory authorities?
Study Data Tabulation Model (SDTM)
Fill in the blank: The _______ model is used for organizing data collected during clinical trials.
SDTM
What is the purpose of the Analysis Data Model (ADaM) in CDISC standards?
To provide a framework for the preparation of analysis datasets.
Multiple choice: Which of the following is NOT a CDISC standard? A) SDTM B) ADaM C) XML D) ODM
C) XML
True or False: CDISC standards help improve the efficiency of data submission and review processes.
True
What is the role of the Operational Data Model (ODM) in CDISC?
To provide a standard for the exchange of clinical trial data.
Short answer: Name one benefit of using CDISC standards.
Improved data consistency and quality.
Fill in the blank: The _______ is a set of guidelines developed by CDISC for the electronic submission of clinical data.
CDASH (Clinical Data Acquisition Standards Harmonization)
What does the CDASH standard focus on?
Standardizing the collection of clinical trial data.
True or False: CDISC standards are only used in the pharmaceutical industry.
False
Multiple choice: Which document provides comprehensive details on CDISC standards? A) CDISC User Guide B) CDISC Submission Guide C) CDISC Standards Repository
C) CDISC Standards Repository
What is the purpose of the Controlled Terminology in CDISC?
To provide standardized definitions for terms used in clinical data.
Short answer: How often does CDISC update its standards?
Regularly, as needed to reflect changes in clinical research practices.
Fill in the blank: The _______ standard is used for defining the structure of clinical trial data.
SDTM
What is the main goal of CDISC?
To facilitate the efficient exchange of clinical trial data.
True or False: CDISC standards are optional for organizations conducting clinical trials.
False
Multiple choice: Which of the following is a key component of the SDTM? A) Domain B) Variable C) Dataset D) All of the above
D) All of the above
Short answer: What is the main use of the ADaM standard?
To create datasets that are suitable for statistical analysis.
Fill in the blank: CDISC standards help in the creation of _______ datasets for regulatory submissions.
standardized
What is the significance of the CDISC implementation guides?
They provide detailed instructions on how to apply CDISC standards.
True or False: CDISC has a collaborative approach involving stakeholders from various sectors.
True
Multiple choice: Which CDISC standard focuses on the clinical study design? A) SDTM B) ADaM C) CDASH D) None of the above
D) None of the above
Short answer: What type of data does the ODM standard handle?
Clinical trial data and metadata.
Fill in the blank: The CDISC _______ is essential for regulatory submissions in the United States.
SDTM
