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ACT Prep VERIFIED SOLUTIONS 2023//2024

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Snowflakes *form from tiny water droplets,* following a specific process of chemical bonding as they freeze, which results in a six-sided figure. A. No change B. form, from tiny, water droplets, C. form from tiny, water, droplets D. form, from tiny water droplets - ANSWER A The rare "triangular" snowflake, *similarly,* confounded scientists for years because it apparently defied the basic laws of chemistry. F. No change G. for example, H. additionally, J. how...

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ACRP-CP 2023 // 2024 With Correct Answers

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Belmont Report (1979) - ANSWER ethical principles and guidelines for the protection of human subjects of research. respect for persons - ANSWER individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ANSWER A person capable of deliberation about personal goals and of acting under the direction of such deliberation

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ACRP CP Exam 2023 Verified 100%

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1571 - ANSWER IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - ANSWER Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - ANSWER Clinical and non-clinical data on the investigational product that is relevant to the study in human subjects; supplied prior to regulatory approval Study type - Open Label - ANSWER e...

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ACRP CCRC EXAM PREP (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated 100% Correct!!

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Approval (in relation to Institutional Review Boards) - ANSWER The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. Audit - ANSWER A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducte...

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ACRP CCRC Exam Prep Questions 2023

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What statements are true concerning an adverse drug reaction? - ANSWERS - All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR - An ADR suggests a relationship to trail medication - All ADRs must be documented What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - ANSWERS - Any AE that results in death - Any AE that results in inpatient hospitalization - Any AE that is a congenital anomaly

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ACRP CCRC Exam Prep Questions 100% SOLUTION

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What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - ANSWER Subject welfare When is the investigator allowed to deviate from t...

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ACRP CCRC exam 100% SOLUTION

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The _________ has developed the Declaration of Helsinki (DoH): - ANSWER 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. - ANSWER the physician (DoH) In medical research, societal/scientific interest should always be prioritized a...

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ACRP CCRC 500 Exam Questions 100% SOLUTION

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A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as a) An adverse event b) An adverse drug reaction c) An unexpected adverse drug reaction d) A serious adverse event b) A causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out A response to a medical product means (check all options that apply) a) A causal relationship bet...

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ACRP CCRA Exam Prep 100.

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Phase I Trial AKA - ANSWER Human Pharmacology Phase I Trial - ANSWER -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA - ANSWER Therapeutic Exploratory Phase II Trial - ANSWER -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying...

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bundle for Acct chapter

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