Acrp exam - Study guides, Class notes & Summaries

ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS/ ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS

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...

ACRP-CP Exam 2023 Questions and Answers

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

Adverse Event (AE)/Adverse Experience - Answer- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) - Answer- All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction - Answer- An adverse reaction, the nature or severity of which is not consistent with the a...

ACRP CCRC exam Question with complete solution 2023The _________ has developed the Declaration of Helsinki (DoH): World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. the physician (DoH) In medical research, societal/scientific interest sh...

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? ...