Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power. Characteristics or indications that subjects must have in order to participate in the clinical trial A. DSMB The probability of detecting a meaningful difference, or effect, if one were to occur B. CRO Prospectively identified and quantifiable parameters that a study is designed to meet C. Inclusion criteria An independent organization that provides management services for clinical trials D. CEC An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study E. Endpoints An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor F. Power An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol G. Core laboratory
Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power. Characteristics or indications that subjects must have in order to participate in the clinical trial A. DSMB The probability of detecting a meaningful difference, or effect, if one were to occur B. CRO Prospectively identified and quantifiable parameters that a study is designed to meet C. Inclusion criteria An independent organization that provides management services for clinical trials D. CEC An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study E. Endpoints An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor F. Power An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol G. Core laboratory
Comprehensive Medical Assisting: Administrative and Clinical Competencies (MindTap Course List)
6th Edition
ISBN:9781305964792
Author:Wilburta Q. Lindh, Carol D. Tamparo, Barbara M. Dahl, Julie Morris, Cindy Correa
Publisher:Wilburta Q. Lindh, Carol D. Tamparo, Barbara M. Dahl, Julie Morris, Cindy Correa
Chapter22: The Patient History And Documentation
Section: Chapter Questions
Problem 8CR
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Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power.
Characteristics or indications that subjects must have in order to participate in the clinical trial
A. DSMB
The probability of detecting a meaningful difference, or effect, if one were to occur
B. CRO
Prospectively identified and quantifiable parameters that a study is designed to meet
C. Inclusion criteria
An independent organization that provides management services for clinical trials
D. CEC
An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study
E. Endpoints
An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor
F. Power
An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol
G. Core laboratory
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