Good Clinical Practice ICH exam 2024 with 100% correct answers Good Clinical Practice Course (Medical Clinical Research) exam 2024 with 100% correct answers
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What is Good Clinical Practice (GCP)? correct answersAn international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? correct answersAssurance that the rig...
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In winkelwagenWhat is Good Clinical Practice (GCP)? correct answersAn international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? correct answersAssurance that the rig...
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigat...
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In winkelwagenAny individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigat...
Which of the following are the three principles included in the Belmont Report? correct answersRespect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? correct answersDetermining that th...
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In winkelwagenWhich of the following are the three principles included in the Belmont Report? correct answersRespect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? correct answersDetermining that th...
Right and Human Safety #1 Priority correct answersBy being in a study, a person is putting themselves at risks they would otherwise not be exposed to had they not signed up for the study. As such, it is the job of the CRC to make sure their rights and safety are always at the forefront of all decisi...
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In winkelwagenRight and Human Safety #1 Priority correct answersBy being in a study, a person is putting themselves at risks they would otherwise not be exposed to had they not signed up for the study. As such, it is the job of the CRC to make sure their rights and safety are always at the forefront of all decisi...
Why is GCP important? correct answersGCP 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 answers1. To protect the rights, safety and welfare of humans participating in research 2...
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In winkelwagenWhy is GCP important? correct answersGCP 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 answers1. To protect the rights, safety and welfare of humans participating in research 2...
what are the three causes that led to the formation of ICH? a. lack of eligible patient to recruit, location of sites, access to treatment b. incomplete medical records, inadequate supplies, equipment not in good working order c. Insufficient laboratory data, sites not conducive to clinical trial...
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In winkelwagenwhat are the three causes that led to the formation of ICH? a. lack of eligible patient to recruit, location of sites, access to treatment b. incomplete medical records, inadequate supplies, equipment not in good working order c. Insufficient laboratory data, sites not conducive to clinical trial...
good clinical practice (GCP) correct answersA standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confident...
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In winkelwagengood clinical practice (GCP) correct answersA standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confident...
- At least 5 members - At least one member whose primary area of interest is in a nonscientific area -At least one member who is independent of the institution/trial site correct answersWhat are the minimum requirements for IRB? 3 years correct answersThe IRB/IEC should retain all relevant reco...
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In winkelwagen- At least 5 members - At least one member whose primary area of interest is in a nonscientific area -At least one member who is independent of the institution/trial site correct answersWhat are the minimum requirements for IRB? 3 years correct answersThe IRB/IEC should retain all relevant reco...
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 re...
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In winkelwagenA 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 re...
An IRB/IEC should safeguard the _______, _______, and ________ of all trial subjects. Special attention should be paid to trials that may include __________ subjects. correct answersRights, safety, and well being. Vulnerable. The IRB/IEC should obtain which documents? correct answersTrial protoco...
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In winkelwagenAn IRB/IEC should safeguard the _______, _______, and ________ of all trial subjects. Special attention should be paid to trials that may include __________ subjects. correct answersRights, safety, and well being. Vulnerable. The IRB/IEC should obtain which documents? correct answersTrial protoco...
Which of the following are the three principles included in the Belmont Report? correct answers• Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? correct answers• Det...
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In winkelwagenWhich of the following are the three principles included in the Belmont Report? correct answers• Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? correct answers• Det...
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...
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In winkelwagenWhich 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...
The difference between a clinical and non-clinical study correct answerstest subjects Responsible for the ongoing safety evaluation of the investigational product correct answersSponsor TRUE/FALSE. The Guidelines for Good Clinical Practice also contains a section on the information requirement...
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In winkelwagenThe difference between a clinical and non-clinical study correct answerstest subjects Responsible for the ongoing safety evaluation of the investigational product correct answersSponsor TRUE/FALSE. The Guidelines for Good Clinical Practice also contains a section on the information requirement...
Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 Glossary of terms Brainpower Read More Previous Play Next Rewind 10 seconds Move forward 10 seconds Unmute 0:03 / 0:15 Full screen Adverse Event (AE) An...
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In winkelwagenAdverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 Glossary of terms Brainpower Read More Previous Play Next Rewind 10 seconds Move forward 10 seconds Unmute 0:03 / 0:15 Full screen Adverse Event (AE) An...
What is the purpose of an IRB? correct answersTo protect the rights and welfare of human subjects of research When must the investigator obtain IRB approval of the study and the consent form? correct answersBefore enrolling any patients in the study The IRB must inform the investigator the stu...
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In winkelwagenWhat is the purpose of an IRB? correct answersTo protect the rights and welfare of human subjects of research When must the investigator obtain IRB approval of the study and the consent form? correct answersBefore enrolling any patients in the study The IRB must inform the investigator the stu...
Adverse Event (AE) correct answersAny 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. Audit correct answersA systematic and independent examination of tr...
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In winkelwagenAdverse Event (AE) correct answersAny 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. Audit correct answersA systematic and independent examination of tr...
After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: A. A phone call telling you the study can now proceed. B. A personal visit from the IRB chair telling you how excited he/she is about your research. C. Written notification of the I...
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In winkelwagenAfter the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: A. A phone call telling you the study can now proceed. B. A personal visit from the IRB chair telling you how excited he/she is about your research. C. Written notification of the I...
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 ...
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In winkelwagenAccording 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 ...
How do we document that a clinical trial has been reviewed and approved by an Institutional Review Board or Ethics Committee? a. Signed Investigator's Brochure Signature Page b. Signed Informed Consent Form c. Formal Letter from the Institutional Review Board or Ethics Committee d. Signed Pro...
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In winkelwagenHow do we document that a clinical trial has been reviewed and approved by an Institutional Review Board or Ethics Committee? a. Signed Investigator's Brochure Signature Page b. Signed Informed Consent Form c. Formal Letter from the Institutional Review Board or Ethics Committee d. Signed Pro...
Pre-Approved clincal experience - all noxious and unintended responses to a medical product related to any dose Marketed Medicinal products- a response to a drug which is noxious and unintended and which occurs at doess normally used. (ICH GCP E6 1.1) correct answersAdverse Drug Reaction (ADR) ...
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In winkelwagenPre-Approved clincal experience - all noxious and unintended responses to a medical product related to any dose Marketed Medicinal products- a response to a drug which is noxious and unintended and which occurs at doess normally used. (ICH GCP E6 1.1) correct answersAdverse Drug Reaction (ADR) ...
In ICH-GCP an audit is defined as A) A systematic and independent examination of trial-related activities and documents B) An investigation intended to discover and verify the clinical effects of an investigational product C) Official review of document facilities records and any other resou...
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In winkelwagenIn ICH-GCP an audit is defined as A) A systematic and independent examination of trial-related activities and documents B) An investigation intended to discover and verify the clinical effects of an investigational product C) Official review of document facilities records and any other resou...
informed consent correct answersprocess which is needed for ethical research in clear, easy to read, accurately reflected, language, with risks listed informed consent doc readability correct answersconsider comprehension and readability, limited med terminology, avoid informal language when i...
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In winkelwageninformed consent correct answersprocess which is needed for ethical research in clear, easy to read, accurately reflected, language, with risks listed informed consent doc readability correct answersconsider comprehension and readability, limited med terminology, avoid informal language when i...
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