Ich gcp guidelines Guides d'étude, Notes de cours & Résumés
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Good Clinical Practice Course (Medical Clinical Research)
- Examen • 11 pages • 2023
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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. - 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 design, conduct, monitoring and reporting of clinical research. ...
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SOCRA CCRP (High Level) Exam with Verified Answers | Latest 2023/2024
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SOCRA CCRP (High Level) Exam with Verified Answers | Latest 2023/2024 
Nuremberg Code (1947) ️ A research ethics code that arose in 
response to the Nazis' inhumane experimentation (nuremberg trials) - 
holocaust, racial hygiene / eugenics / master race. 
The Nuremberg Code - 10 points ️ 1. voluntary 
2. necessary for results 
3. logical design and results 
4. avoid unnecessary harm 
5. cannot result in death or disablement 
6. risk assessment 
7. protect subjects against harm 
8. qualified...
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Good Clinical Practice Course (Medical Clinical Research) exam 2024 with 100% correct answers
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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 answersb. Minimize the need for redundant research 
 
The ICH GCP guidelines: 
a. Require certification of clinical research sites and investigators 
b. Set standards for the design, conduct, monitoring and reporting of clinical resea...
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Socra Exam Prep questions and answers
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Laws - passed by national legislative bodies; establish authority of national regulatory body 
 
Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law 
 
guidance - "current thinking" of regulatory bodies; non-binding 
 
ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration 
 
SOPs - developed by an organization (sp...
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SOCRA - CCRP (high level) Exam Questions and Answers (GRADED A+)
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Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) 
 
Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. 
 
Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). 
 
GCP v Declaration of Helinski - ANSWER -GCP lacks moral principles an...
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ICH E6(R2)- Interpretation and Application exam with 100% correct answers
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ICH stands for correct answersInternational Council for Harmonisation 
 
Regulatory Reviewers focus on correct answersFocus on study validity and results- want to see GCP used to produce high quality data based on the protocol 
 
Inspectors focus on correct answersFocus on study conduct and oversight 
 
True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration correct answersTrue 
 
What is the missi...
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SOCRA - CCRP (high level) Exam Questions with 100% Correct Answers
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Nuremberg Code (1947) Correct Answer A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
The Nuremberg Code - 10 points Correct Answer 1. voluntary 
2. necessary for results 
3. logical design and results 
4. avoid unnecessary harm 
5. cannot result in death or disablement 
6. risk assessment 
7. protect subjects against harm 
8. qualified investigators 
9. right to withdrawal 
10. right...
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SOCRA - CCRP (high level)Exam Review Questions.
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SOCRA - CCRP (high level)Exam Review Questions. 
Nuremberg Code (1947) - correct answer A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
The Nuremberg Code - 10 points - correct answer 1. voluntary 
2. necessary for results 
3. logical design and results 
4. avoid unnecessary harm 
5. cannot result in death or disablement 
6. risk assessment 
7. protect subjects against harm 
8. quali...
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Clinical Training with answers graded A+ 2023/2024
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Clinical TrainingWhat 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 participants in clinical trials are protected. 
T...
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CRA interview exam questions & answers 2024/2025
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CRA interview exam questions & answers 2024/2025 
 
 
ICH GCP Guidelines - ANSWERSSet standards for the design, conduct, monitoring and reporting of clinical research. 
ICH - International Council for Harmonization 
GCP - Good Clinical Practice 
This is important because it ensures the quality of the information collected 
 
What is an SAE and how is it reported? Name 3 SAE's - ANSWERSSerious Adverse Event that is 1. life threatening 2. results in death 3. Prolonged hospitalization 4. Disabili...
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