Ccrp written exam Study guides, Class notes & Summaries
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CCRP SoCRA Exam Latest Update Rated A
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CCRP SoCRA Exam Latest Update Rated A 
21 CFR Part 11 Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B Electronic Records 
21 CFR Part 11 Subpart C Electronic Signatures 
21 CFR Part 50 Protection of Human Subjects 
21 CFR Part 50 Subpart B Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 
21 CFR Part 56 Institutional Review Board 
21 CFR Part 56 Subpart B Organization and Personnel 
21 CFR Part 56 Subpa...
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CCRP WRITTEN EXAM.
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CCRP WRITTEN EXAM. 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days 
 
How many members must sit on an IRB? - correct answer 5 
 
How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research 
 
What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subjects i...
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ACRP CCRA/CCRC Certification Exam prep written March 2023
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ACRP CCRA/CCRC Certification Exam prep written March 2023 
 
 
Adverse Event (AE)/Adverse Experience - answerAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. 
 
Adverse Drug Reaction (ADR) - answerAll noxious and unintended response to a medicinal product related to any dose. 
 
Unexpected Adverse Drug Reaction - answerAn adverse reaction, th...
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
- Exam (elaborations) • 11 pages • 2023
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
 
 
 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
 
 
 
A significant risk device is defined as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the health, s...
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CCRP SOCRA Exam - Practice Exam 1 Latest Update Already Passed
- Exam (elaborations) • 20 pages • 2024
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CCRP SOCRA Exam - Practice Exam 1 Latest Update Already Passed 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor 
What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 
A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subje...
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CCRP SOCRA Exam - Practice Exam #1 Questions And Answers All Verified
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CCRP SOCRA Exam - Practice Exam #1 Questions And Answers All Verified 
 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
 
 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
 
 
A significant risk device is defined as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the hea...
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CCRP Patient Assessment Written Exam.
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CCRP Patient Assessment Written Exam. 
Assessment - correct answer an objective evaluation or 
appraisal of an individual's health status, 
including acute and chronic conditions 
 
How does an assessment gather information? - correct answer 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 th...
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CCRP Certification Exam Quiz with Approved Answers | Latest 2023/2024
- Exam (elaborations) • 18 pages • 2023
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CCRP Certification Exam Quiz with Approved Answers | Latest 2023/2024 
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 l...
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CCRP SOCRA Exam - Practice Exam 1 with Complete Solutions
- Exam (elaborations) • 20 pages • 2023
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CCRP SOCRA Exam - Practice Exam 1 with Complete Solutions 
NB: Answers to questions appear at the bottom of the choices and are highlighted in yellow 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor 
What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 
A significant risk device is defined as an investigational device that is: A) Intended as an implant...
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CCRP SOCRA Exam - Practice Exam 1
- Exam (elaborations) • 17 pages • 2024
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CCRP SOCRA Exam - Practice Exam 1 
 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
A significant risk device is defined as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject 
 
B) P...
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