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ACRP-CP Exam with Questions and Answers 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...

ICH E11 ACRP Exam with Questions and Answers The number of medicinal products currently labeled for pediatric use is limited. It is the goal of the guidance of ICH E11, CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION to encourage and facilitate timely pediatric medicinal ...

ACRP- Clinical Research Knowledge Assessment (CRKA) with Questions and Answers True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. ANSWER False As part of their risk assessment process the sponsor determines that there is a high likelihood that en...

ACRP CCRC Exam with Questions and Answers 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 ...

ACRP CCRC Test with Questions and Answers A protocol requires that subjects in a hypertension trial have two consecutive sitting diastolic blood pressure readings performed and the average of the two recorded on the CRF. The CRA discovers that only one blood pressure reading is recorded in the so...

ACRP CCRC ICH GCP - Investigator's Brochure Exam with Questions and Answers Define the purpose of the Investigator's Brochure? ANSWER The IB explains the rationale for the trial, the dose, dose frequency/interval, methods of administration, and safety monitoring procedure. It also explains the ...

ACRP Practice Exam Questions and Answers A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? a. The benefits section should be left out of the ICF, as it is not applicable. b...

ACRP Exam Abbreviations List with Complete Definitions ADR ANSWER Adverse Drug Reaction - Pre-approval - all noxious, unintended responses to a medicinal product at any dose. - marketed - all noxious, unintended responses to a medicinal product at any dose normally used. - causal or cannot b...

ACRP CCRA Exam Prep with Latest Questions and Accurate Answers 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 ...

CRA ACRP Practice Exam Questions with Explained Answers A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects ANSWER 1 and 3 only. E6 8.3.20 A screening log wi...

ACRP CCRC Exam Prep Questions and Verified Answers 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 suf...

ACRP-CP Exam (Graded A Plus) with Questions and Answers Crossover ANSWER when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel ANSWER when subjects are randomized to 1 of 2 or more arms, each arm being all...

ACRP CCRC Exam Practice Questions and Verified Solutions What is the goal of a Confirmatory trial? ANSWER to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? ANSWER to help provide a basis for confirmatory trials When is a composite variable useful? ANSW...