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CCRP Bundled Exams with Complete Solution | Verified | Guaranteed Success
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CCRP EXAMS BUNDLE ~ Questions with 100% Correct Answers/Already Grade A+
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CCRP EXAMS BUNDLE ~ Questions with 100% Correct Answers/Already Grade A+
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CCRP EXAM WITH 185 QUESTIONS AND ANSWERS 2023
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CCRP EXAM WITH 185 QUESTIONS AND ANSWERS 2023
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CCRP EXAM/275 QUESTIONS AND ANSWERS
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CCRP EXAM/275 QUESTIONS AND ANSWERS
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CCRP Patient Assessment Exam with Questions and Answers/100% Correct/ Grade A+
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Assessment - an objective evaluation or 
appraisal of an individual's health status, 
including acute and chronic conditions 
How does an assessment gather information? - through collection of data, observation, 
and physical examination 
What type of assessment? 
•Gather information about the patient from available sources such as medical records or 
reports from diagnostic studies 
• Perform direct measurements on the patient such as 12-lead EKG, blood pressure, or body 
mass index - obje...
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CCRP Exam with Questions and Answers/100% Correct/ Grade A+
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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 
working days 
How many members must sit on an IRB? - 5 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of 
research 
What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are 
minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subjects is equitable 
4. Informed consent will be sought from subjects or LARs 
5. Informed ...
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CCRP Exam with Questions and Answers/100% Correct/ Grade A+
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Year/ description of the Nuremberg Code - 1947- German physicians conducted 
unethical experiments on concentration camp prisoners without their consent. 
What implications came of the Nuremberg Code? - Ten elements of human research 
including voluntary informed consent is absolutely essential. 
Year and description of the Declaration of Helsinki - 1964- Based on the principles of the 
Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First 
significant effort of th...
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CCRP Exam with Questions and Answers/100% Correct/ Grade A+
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SAE - Serious Adverse Event: 
- results in death 
- is life threatening (patient was at risk of death at time of the event) 
- results in persistent or significant disability 
- congenital anomaly/birth defect 
Short Form - A document that states that the elements of informed consent have been 
presented orally to and understood by the participant or the participant's LAR. 
4 components of short form - 1. A short form consent document 
2. And oral presentation of the required elements of consen...
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CCRP Exam with Questions and Answers/100% Correct/ Grade A+
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21 CFR 11 - Electronic Records; Electronic Signatures 
B - Electronic Records 
C - Electronic Signatures 
21 CFR 50 - Protection of Human Subjects/Informed Consent 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements for Emergency Research 
50.25 - Elements of Informed Consent 
50.27 - Documentation of Informed Consent 
D - Additional Safeguards for Children 
21 CFR 50 Subpart B - 50.25 Elements of Informed Consent
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CCRP Exam with Practice Questions and Answers/100% Correct/ Grade A+
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Prior to archiving a study, documentation of IP destruction at the site should be filed in the 
study files of the: - PI and Sponsor. 
In the case of an incapacitated subject, who should receive a copy of the signed and dated 
ICF? - The subject's legally acceptable representative 
Which of the following required elements should be included in a clinical trial protocol? - 
The subject inclusion and exclusion criteria 
During a multi-site clinical study, whose responsibility is it to report subj...
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CCRP Exam 2024 with 100%Correct Answers.
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CCRP Exam 2024 with 100%Correct Answers. 
How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 
working days 
How many members must sit on an IRB? correct answer5 
How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research 
What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subj...
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