Ich gcp Study guides, Class notes & Summaries
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SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide 
 
Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? 
 
Answer: 
1) Progress of investigations under IND 
2) Secure compliance or discontinue investigators that are not compliant and notify FDA 
3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 
4) Notify FDA, all IRBs and all investigators if drug presen...
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ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11) with Complete Answers
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ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11) with Complete Ans 
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of phys...
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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) Correct Answer: All noxious and unintended responses to a 
medicinal product related to any dose 
E6(R1) 1 Correct Answer: Glossary of terms 
Adverse Event (AE) Correct 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 uninten...
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Pharmaschool.co ICH GCP 106 Questions And Answers Graded A+
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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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Pharma school ICH GCP Questions with correct answers
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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 CORRECT ANSWER c. CTA and Ethics Committee Approval 
 
What C is missing from this statement in ICH GCP: The sponsor should provide insurance or should indemnify...
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ACRP Boot camp Exam Questions and Answers Already Passed
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ACRP Boot camp Exam Questions and Answers Already Passed 
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 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 d 
Who is ultimately responsible for all aspects of the research conducted at a site? 
...
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Comparison Between ICH GCP E6 and U.S. FDA Regulations Questions and Answers with complete solution
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CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and 
access by third parties. If investigators are complying with ICH E6 guideline, they mus - Clearly 
disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory 
authorities may have access to the subject's medical record 
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality 
throughout all stages of the trial pro...
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ICH GCP for CCRC Exam Prep 543 Questions with verified Answers 2024 Graded A+.
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ICH GCP for CCRC Exam Prep 543 Questions with verified Answers 2024 Graded A+. 
 
Adverse Drug Reaction (ADR) -correct answer-All noxious and unintended responses to a medicinal product related to any dose 
 
E6(R1) 1 -correct answer-Glossary of terms 
 
Adverse Event (AE) -correct 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 unfavorabl...
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SOCRA- 2022 QUESTIONS AND ANSWERS ALL CORRECT
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Belmont Report was created as part of? Correct Answer: The national Research Act of 1974. 
 
Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research. 
 
What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations. 
 
What year was GCP and HIPAA created? Correct Answer: 1996 
 
What is the National Research Act? Correct Answer: ...
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Pharmaschool.co ICH GCP Q&A
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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 - Answer- c. CTA and Ethics Committee Approval 
 
What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (lega...