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CRC Training Study Guide DAY 2 questions with answers
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CRC Training Study Guide DAY 2questions with answers.
Why do I need to be credentialed? ANS - To provide a culture of safety
To protect the Emory good name
To follow The Joint Commission standards
To define the scope of role authorized
To standardize and verify levels of competency for skills
To abide by legal standards
Who needs to be privileged? ANS - Medical Staff
Who needs to be authorized? ANS - Everyone except Medial Staff
What is EeMR? ANS - Emory Electronic Medical Record
What is the Emory Electronic Medical Record project? ANS - The transformation of patient care
through technology and process redesign across all Emory Healthcare entities
What is CPOE? ANS - computerized provider order entry
consist of Medical & Nursing plans of care.
Research nurses and coordinators
(mandatory training required)
Documentation ANS - is the key to demonstrating that the protocol & regulations have been followed.
should provide assurance that the rights, safety, and well being of subjects are protected, and that the
clinical trial data are credible
, Good Clinical Practice (GCP) ANS - ICH-E6 provides standards which delineate documentation required
to demonstrate compliance with regulatory requirements.
provides lists of Essential Documents for the Conduct of a Clinical Trial
Regulatory files contain study specific what? ANS - Documents
Regulatory Files ANS - Provide the ability to recreate the study from start to finish
Organize study information, communications, & documentation
May or may not be a physical binder.
What should not be kept in a regulatory file? ANS - Internal audit/quality management reports
Financial information
Subject information
Subject Files contain what? ANS - subject specific documents
Subject Files ANS - Regulations refer to as case histories
Provide the ability to recreate the subject's participation
Include documentation that the rights, safety, and well being of subjects are protected
Include information recorded on case report forms (CRFs) and source records
source data ANS - Supporting data or "________ _______" is contained in "source documents"
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