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CRC EXAM QUESTIONS WITH REVIWED ACCURATE ANSWERS.
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CRC EXAM QUESTIONS WITH REVIWED ACCURATE ANSWERS.
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CRC EXAM QUESTIONS WITH REVIWEDACCURATE ANSWERS.
Delegation of Authority log ANS - List of qualified staff to whom trial tasks have been delegated
FDA Form 1572 ANS - Statement of Investigator.
This is an agreement signed by the investigator to provide information to the sponsor and assure that
he/she will comply with FDA regulations related to the conduct of a clinical investigation of an
investigational product.
double-blind study ANS - study in which neither the experimenter nor the subjects know if the subjects
are in the experimental or control group
Open Label Study ANS - A clinical trial in which subjects and investigators are aware of the treatment
received.
source documents ANS - document in which data from clinical trials is first documented
Case Report form ANS - document used to record all of the protocol required info to be reported to the
sponsor on each trial subject
Indemnification ANS - statement that we will not be held liable for patients during their participation in
clinical trials
inclusion and exclusion criteria ANS - Sets of criteria that determine who can and cannot participate in
a study
serious adverse event ANS - Any change in a pts health that results in hospitalization, death, life
threatening events, disability
, Tourniquet left on too long results in ANS - bruising, blood flow stops, specimens hemolyzed and
elevated chemistry results
IRB continuing review ANS - Completed annually, IRB re-approval.
TIA ANS - transient ischemic attack (mini stroke)
Heart Attack ANS - Myocardial Infarction
Stroke ANS - Cerebrovascular Accident (CVA)
PHI ANS - Protected health information, any info about health status, provision of health care, or
payment for healthcare
revised consent form ANS - -Document the date and time of changes
-Fill out a reg revision form
-Train all staff on DOA of changes and sign a training memo
-reconsent patients
-file in regulatory binder
Financial Disclosure ANS - Document that certifies the absence of certain financial interests or
arrangements of the investigator that could affect the reliability of study data
IND Safety report ANS - Report for any suspected AEs or SAEs. PI must sign and date and file in reg
binder
Systolic pressure ANS - 2nd regular tap sound. Pressure in arteries during contraction (korotkoff sound)
Proper cuff size ANS - Measure elbow to shoulder, then circumference at the midpoint.
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