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[Show more]ACRP CCRA Exam 
Prep 100% 
SOLUTION 
Phase I Trial AKA - ANSWER Human Pharmacology 
Phase I Trial - ANSWER -Assess tolerance. 
-Define/describe PK and PD. 
-Explore drug metabolism and drug interactions, estimate activity. 
-Done in healthy volunteers.10 -100 people 
Phase II Trial AKA - ANSWER...
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Prep 100% 
SOLUTION 
Phase I Trial AKA - ANSWER Human Pharmacology 
Phase I Trial - ANSWER -Assess tolerance. 
-Define/describe PK and PD. 
-Explore drug metabolism and drug interactions, estimate activity. 
-Done in healthy volunteers.10 -100 people 
Phase II Trial AKA - ANSWER...
ACRP CCRC 500 
Exam Questions 
100% SOLUTION 
c) Is not necessarily causally related to drug 
An adverse event is defined as one which 
a) Results in hospitalization 
b) Causes a disability 
c) Is not necessarily causally related to drug 
d) Is life threatening 
d) a and b 
An adverse event is one ...
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Exam Questions 
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c) Is not necessarily causally related to drug 
An adverse event is defined as one which 
a) Results in hospitalization 
b) Causes a disability 
c) Is not necessarily causally related to drug 
d) Is life threatening 
d) a and b 
An adverse event is one ...
ACRP CCRC exam 
100% SOLUTION 
The _________ has developed the Declaration of Helsinki (DoH): - ANSWER World 
Medical Association; as a statement of ethical principles to provide guidance to 
physicians and other participats in medical research involving human subjects. 
(DoH) It is the duty of __...
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100% SOLUTION 
The _________ has developed the Declaration of Helsinki (DoH): - ANSWER World 
Medical Association; as a statement of ethical principles to provide guidance to 
physicians and other participats in medical research involving human subjects. 
(DoH) It is the duty of __...
ACRP CCRC Exam 
Prep Questions 
100% SOLUTION 
What are expected or possible consequences of over-estimation of recruitment 
potential? - ANSWER - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have suffi...
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Prep Questions 
100% SOLUTION 
What are expected or possible consequences of over-estimation of recruitment 
potential? - ANSWER - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have suffi...
ACRP CCRC Exam Prep Questions 
2023//2024 
What are expected or possible consequences of over-estimation of recruitment 
potential? - ANSWERS - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have sufficien...
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Add to cartACRP CCRC Exam Prep Questions 
2023//2024 
What are expected or possible consequences of over-estimation of recruitment 
potential? - ANSWERS - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have sufficien...
ACRP CCRC EXAM 
PREP (Based on 
Declaration of 
Helsinki and ICH 
E2A, E6_R2, E8, E9, 
E11)Rated 100% 
Correct!! 
Adverse Drug Reaction (ADR) - ANSWER In the pre-approval clinical experience with a 
new medicinal product or its new usages, particularly as the therapeutic dose(s) may 
not be ...
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PREP (Based on 
Declaration of 
Helsinki and ICH 
E2A, E6_R2, E8, E9, 
E11)Rated 100% 
Correct!! 
Adverse Drug Reaction (ADR) - ANSWER In the pre-approval clinical experience with a 
new medicinal product or its new usages, particularly as the therapeutic dose(s) may 
not be ...
ACRP CP Exam 2023 
Verified 100% 
1571 - ANSWER IND application; Permit to do research on humans for the first time; 
has background info; and rationale; updated annually 
1572 - ANSWER Investigator statement; commitment, done nationally and 
internationally by sponsors intending to hava marketin...
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Verified 100% 
1571 - ANSWER IND application; Permit to do research on humans for the first time; 
has background info; and rationale; updated annually 
1572 - ANSWER Investigator statement; commitment, done nationally and 
internationally by sponsors intending to hava marketin...
ACRP CP FINAL EXAM LATEST 2023 REAL 
EXAM 150 QUESTIONS AND CORRECT 
ANSWERS|AGRADE 
What would be the first priority for an investigator when a subject wishes to 
withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's 
reason for withdrawal. 
CRO recently switched from pape...
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Add to cartACRP CP FINAL EXAM LATEST 2023 REAL 
EXAM 150 QUESTIONS AND CORRECT 
ANSWERS|AGRADE 
What would be the first priority for an investigator when a subject wishes to 
withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's 
reason for withdrawal. 
CRO recently switched from pape...
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