Gcp Samenvattingen, Notities en Examens
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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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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 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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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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Bundle for Good Clinical Practice (GCP) Exams Compilation | Verified | Guaranteed Success
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Bundle for Good Clinical Practice (GCP) Exams Compilation | Verified | Guaranteed Success
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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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GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT
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GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT 
What words are missing from the following in ICH GCP: The Sponsor should update the XXXX as significant new information becomes available? 
investigator's brochure 
 
 
 
Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs: 
sponsor 
 
 
 
According to ICH GCP section 8, what is the purpose of IRB/IEC composition? 
A. To document that the IRB/IEC is constituted in agreement with GCP 
 
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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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