According to ich gcp - Study guides, Class notes & Summaries

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 ...

PHARMASCHOOL.CO ICH GCP FINAL EXAM WITH ALL QUESTIONS AND ANSWERS ...

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) 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. (ICH...

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...

CCRC Module 3: GCP for the Experienced Clinical Research Professional Exam Questions and answers, verified/ __ __ is defined as "all those planned and systemic actions that are established to ensure that the trial is performed and data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s)" [ICH1.46] - -Quality Assurance (QA) is defined as "all those planned and systemic actions that are established to ensure that th...

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 - Answer 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 - Answer d Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal inve...

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 physiological function Adverse Event (AE) - Answer Any untoward medical occurrence in a patient or clin...

Where should subject identification code list be filed? - Answer- The investigator file only According to ICH GCP, the definition of Sponsor-Investigator is: An individual who XXXX, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. - Answer- Both initiates and conducts Complete this segment from ICH GCP regarding what IMP procedures for sites should include: adequate and safe recei...

CCRC Exam Prep - GCP E6(R2) Glossary. Questions and answers, rated A+ 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) - -Adverse Drug Reaction (ADR) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does n...

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 ...