Ich gcp practice - Study guides, Class notes & Summaries

ICH GCP REVIEW PRACTICE TEST CORRECTLY ANSWERED. FDA - CORRECT ANSWER Food and Drug Administration ICH - CORRECT ANSWER International Conference of Harmonization - homogenized regulations in many drug markets including the US, EU, and Japan. GCP - CORRECT ANSWER Good Clinical Practice Bioavailability - CORRECT ANSWER The degree to which a drug is absorbed or becomes available to a specified location within the body Clinical Trial - CORRECT ANSWER Any study, utilizing human subje...

Nuremberg Code (1947) Correct Answer A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points Correct Answer 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right...

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 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinic...

CRA interview exam questions & answers 2024/2025 ICH GCP Guidelines - ANSWERSSet standards for the design, conduct, monitoring and reporting of clinical research. ICH - International Council for Harmonization GCP - Good Clinical Practice This is important because it ensures the quality of the information collected What is an SAE and how is it reported? Name 3 SAE's - ANSWERSSerious Adverse Event that is 1. life threatening 2. results in death 3. Prolonged hospitalization 4. Disabili...

Good Clinical practice (ICH) Questions and Answers Graded A+ 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 expecte...

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...

ICH GCP for CCRC Exam Prep Questions and Answers 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...

Belmont Report was created as part of? - ANSWER-The national Research Act of 1974. Who was the Belmont Report formulated by? - 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? - ANSWER-1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? - ANSWER-1996 What is the National Research Act? - ANSWER-A set of regulations for the protection...

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 ...