Ich gcp guidelines Guides d'étude, Notes de cours & Résumés
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Good Clinical Practice Course (Medical Clinical Research) Questions with complete solution 2023/2024
- Examen • 14 pages • 2023
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Good Clinical Practice Course (Medical Clinical Research) Questions with complete solution 2023/2024 
A primary purpose of the ICH is to: 
a. Require FDA registration of worldwide clinical trials. 
b. Minimize the need for redundant research. 
c. Require publication of negative trial results. 
d. Develop mandatory worldwide regulations for drug development. - correct answer b. Minimize the need for redundant research 
 
The ICH GCP guidelines: 
a. Require certification of clinical research sites...
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Good Clinical Practice Course (Medical Clinical Research)question n answers graded A+
- Examen • 14 pages • 2024
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Good Clinical Practice Course (Medical Clinical Research)A primary purpose of the ICH is to: 
a. Require FDA registration of worldwide clinical trials. 
b. Minimize the need for redundant research. 
c. Require publication of negative trial results. 
d. Develop mandatory worldwide regulations for drug development. - correct answer b. Minimize the need for redundant research 
 
The ICH GCP guidelines: 
a. Require certification of clinical research sites and investigators 
b. Set standards for the ...
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Clinical Training Question and answers already passed 2023/2024
- Examen • 10 pages • 2023
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Clinical Training Question and answers already passed 2023/2024What is Good Clinical Practice (GCP)? - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. 
GCP guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants 
 
What is the purpose of the ICH GCP guidelines? - correct answer To ensure that the rights, safety, and confidentiality of par...
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ACRP CCRC Exam Prep Questions(Module Quiz Questions)And Answers 2023
- Examen • 24 pages • 2024
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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 sufficient data within the required timeframe and will be 
stopped because of lack of budget 
What should be the first consideration when conducting a clinical trial? - Answer 
Subject welfare 
When is the investigator allowed to deviate from the protoco...
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Good Clinical Practice (GCP) jds fully solved graded A+ 2023/2024
- Examen • 5 pages • 2023
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Good Clinical Practice (GCP) Why is GCP important? - correct answer GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected 
 
What are the goals of GCP? - correct answer 1. To protect the rights, safety and welfare of humans participating in research 
 
2. To assure the quality, reliability and integrity of data collected 
 
3. To provide standards and guidelines for the conduct of clinical research 
 
4. Good Clinical...
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GCP- Social and Behavioral Research Best Practices for Clinical Research Questions and Answers | Latest Update | 2024/2025 | Already Passed
- Examen • 16 pages • 2024
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GCP- Social and Behavioral Research 
Best Practices for Clinical Research 
Questions and Answers | Latest Update | 
 
2024/2025 | Already Passed 
 
What could you say in response to someone who says Good Clinical Practice (GCP) is mostly 
about curbing abuses by unscrupulous researchers? 
 
a. That's correct, GCP is all about strict rules 
b. That's not true, GCP is more focused on participant behavior 
c. It's true that GCP was developed to address concerns about unethical behavior, but it'...
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ACRP Bootcamp Exam Complete Questions And Answers 2024
- Examen • 12 pages • 2024
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ACRP Bootcamp Exam Complete 
Questions And Answers 2024 
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: 
a. phase 1 
b. phase 2 
c. phase 3 
d. phase 4 - Answer ️️ -a 
Which of the following is not a type of patient-oriented research? 
a. IND/IDE clinical trials 
b. investigator initiated trial (IIT) 
c. Post market device registries 
d. outcome and health services research - Answer ️️ -d 
Who is ultimately responsible for all aspects of ...
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ACRP CP Exam Questions and Answers 100% Pass
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ACRP CP Exam Questions and Answers 100% Pass 
Phase I -Answer-The clinical trial phase that focuses on safety and human 
pharmacology in healthy volunteers 
Who is ultimately responsible for all aspects of the research conducted at a site? - 
Answer-Principal investigator 
Define GCP -Answer-An international quality standard that is provided by ICH E6(R2) 
describing safety, accuracy of trials and credibility of data 
What event resulted in the Nuremburg Cod of 1949 -Answer-Nazi Medical Experime...
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Good Clinical Practice (GCP) Questions and Answers | Latest Version | 2024/2025 | Already Passed
- Examen • 11 pages • 2024
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Good Clinical Practice (GCP) Questions 
and Answers | Latest Version | 2024/2025 
 
| Already Passed 
 
1. **What are the three fundamental principles outlined in the Belmont Report?** 
Respect for Persons, Beneficence, Justice. 
 
2. **How can the Principle of Beneficence be implemented in a research study involving human 
participants?** 
By ensuring that the study maximizes potential benefits while minimizing possible risks. 
 
3. **What best encapsulates the principle of Respect for Persons ...
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CITI Training 134 Questions With Complete Solutions Latest Update 2023-2024 Score A+
- Examen • 13 pages • 2023
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CITI Training 134 Questions With Complete Solutions Latest Update Score A+. What must you file before conducting human clinical trials with an experimental drug? Correct 
Answer: IND application (Form FDA 1571) 
During the clinical development phase of the IND process, what must sponsors do? Correct 
Answer: Maintain current IND application by amending IND with new Form FDA 1571 and 
providing FDA with: 
safety updates 
copies of new protocols 
FDA 1572 
Annual Progress reports 
this document n...
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