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Socra CCRP Exam Bundle Questions and Answers 100 % VERIFIED!!

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SOCRA (CCRP) Exam Practice Questions With Correct Answers

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Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Rep...

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SOCRA - CCRP (high level) Exam Questions and Answers (GRADED A+)

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Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of...

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SOCRA CCRP Certification Exam With Complete Solutions

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Nuremburg Code elements - ANSWER -1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparation...

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SoCRA Certification Exam Questions and Answers 100% Correct

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Closed System - ANSWER -An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - ANSWER -An electronic signature based upon cryptographic methods of originator authentic...

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SOCRA CCRP Exam Questions and Answers 100% Solved

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Quality - ANSWER -ICH Q Efficacy - ANSWER -ICH E Safety - ANSWER -ICH S Multidisciplinary - ANSWER -ICH M guidance for industry, consolidated guideance - ANSWER -ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER -ICH E2A Safety pharmacology studies for huma...

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Socra CCRP Exam Questions and Answers(SCORED A+)

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When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER- False-they must sign both What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles ...

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