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ACRP CCRC Bundle Set

ACRP CCRC Bundle Set

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ACRP CCRC EXAM PREP questions with correct answers

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Adverse Drug Reaction (ADR) Answer In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug...

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ACRP CCRC Exam Prep Questions with correct answers

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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...

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ACRP CCRC Exam Prep Questions with correct answers

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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...

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CCRC Exam questions with correct answers

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Clinical Trial Answer process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Answer Clinical event, measurable indicator, subject reported response...

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CCRC Exam Prep questions with correct answers

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What is an Adverse Event (AE) ? Answer 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 GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? Answe...

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CCRC Exam questions with correct answers

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What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? Answer To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define G...

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ACRP CCRC exam questions with correct answers

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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 ...

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CCRC Exam - Section 1 questions with correct answers

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CCRC Exam - Section 1 questions with correct answers

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ACRP-CCRC questions with correct answers

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ICH E6 (R2) Answer ICH guideline that is known as GCP guideline 21 CFR 312.3 Answer Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Phase I Answer Clinical tr...

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ACRP CCRC Practice Questions with correct answers

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1. 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 compliance is he? A. 50% B. 64% C. 78% D. 100% 1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (...

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CCRC Exam questions with correct answers

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This phase determines therapeutic benefit and is usually done in a larger, specific population. Answer Phase 3 The purpose of source documentation is Answer To verify that the date in case report forms are consistent with that in the source documents (ICH E6 sec 8.3.13) What is the minimum nu...

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CCRC ICH questions with correct answers

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What is pharmacokinetics? Answer Study of a drug's absorption, distribution, metabolism, and excretion. What is pharmacodynamics? Answer Study of effects of drugs on the body and their mechanism of action. What is pharmacology? Answer Study of uses, effects, and modes of action of drugs Wh...

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