According to ich gcp - Study guides, Class notes & Summaries
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ACRP Exam Questions With Latest Solutions 2024
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ACRP Exam Questions With Latest 
Solutions 2024 
1. What is the purpose of ICH-GCP? 
a. To standardize the design, conduct, recording, and reporting of clinical trials 
b. To instruct clinicians as to how to conduct preclinical toxicology tests 
c. To ensure that subjects are treated with the best available therapy 
d. To increase the number of abbreviations used in clinical practice - answera 
2. What is the purpose of the IRB/IEC? 
a. To help ensure that trials are 
conducted according to the ...
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ACRP-CCRC questions with correct answers
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ICH E6 (R2) Answer ICH guideline that is known as GCP guideline 
 
21 CFR 312.3 Answer Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. 
 
Phase I Answer Clinical trial phase that focuses on safety and human pharmacology in healthy volunteers. 
 
Principal Investigator Answer Ultimately responsible for all aspects of the research conducted at a site. 
 
GCP (Good...
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ACRP CCRC Exam Prep Questions(Module Quiz Questions)And Answers 2023
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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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ICH GCP for CCRC Exam Prep 100% SOLUTION
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ICH GCP for CCRC 
Exam Prep 100% 
SOLUTION 
Adverse Drug Reaction (ADR) - ANSWER All noxious and unintended responses to a 
medicinal product related to any dose 
E6(R1) 1 - ANSWER Glossary of terms 
Adverse Event (AE) - ANSWER Any untoward medical occurrence in a patient or 
clinical investigation subject administered a pharmaceutical product and which does not 
necessarily have a causal relationship with this treatment--any unfavorable and 
unintended sign , symptom, or disease temporal...
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ACRP CCRA/CCRC Certification Exam Prep 2023-2024 with Complete Solutions!!
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Adverse Event (AE)/Adverse Experience - ANSWER-Any 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) - ANSWER-All noxious and unintended response to a medicinal product related to any dose. 
 
Unexpected Adverse Drug Reaction - ANSWER-An adverse reaction, the nature or severity of which is not consistent with the appl...
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Good Clinical practice (ICH) correctly answered 2023/2024
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Good Clinical practice (ICH)Which of the following is NOT a principle of GCP: (Please select all that apply) 
Any foreseeable risks and inconveniences must be weighed up against any benefits 
 
Information must be recorded, handled and stored in a manner that allows accurate reporting, interpretation and verification and which ensures the confidentiality of participants' records. 
 
Publication of results is not required if the study results were not as expected. 
 
The study protocol must pro...
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Btech GCP Quiz 8-9 Latest Update | 100% Verified
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Btech GCP Quiz 8-9 Latest Update | 
 
100% Verified 
 
Q 1 
 
Good Clinical Practices (GCP) are global ethical and scientific quality standards used to conduct, 
document, and report human clinical trials. These standards ensure the protection of trial 
participants' rights, safety, and well-being. Where can you find GCP regulations and guidelines? 
ICH E6, 21 CFR part 56, 21 CFR part 50, 21 CFR part 46 
 
Not 21 CFR part 96 
 
Which principle aligns with GCP according to ICH (International Con...
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Pharmaschool.co ICH GCP exam 1 Already Passed!!
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According to ICH GCP what are the absolute minimum requirements for essential documents at site 
before IMP can be sent to the site? 
a. CV of investigator and Clinical Trial Authorization (CTA) 
b. Ethics Committee Approval and signed protocol 
c. CTA and Ethics Committee Approval 
d. CTA, Ethics Committee Approval and signed protocol - c. CTA and Ethics Committee Approval 
What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should 
indemnify (legal and fina...
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ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+.
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ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+. 
 
Adverse Drug Reaction (ADR) 
All noxious and unintended responses to a medicinal product related to any dose 
E6(R1) 1 
Glossary of terms 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment--any unfavorable and unintended sign , symptom, or disease temporally asso...
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MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST.
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MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 
5 - correct answer The minimum number of IRB members 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
The Sponsor - correct answer The responsibility for ensuring that the investigator understands a clinical trial lies with: 
 
A subject has been enrolled on a ...
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