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BUNDLE - CCRP EXAMS

BUNDLE - CCRP EXAMS

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SOCRA CCRP Exam 2023 with 100% correct answers

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SOCRA CCRP Exam 2023 April 30 1996 Quality Efficacy Safety Multidisciplinary guidance for industry, consolidated guideance Clinical Safety Data Management Definitions and Standards Safety pharmacology studies for human pharmaceuticals Electronic records, electronic signatures ...

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SOCRA - CCRP (high level) exam 2023 with 100% correct answers

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Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid...

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CCRP Exam 2023 with complete solutions

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CCRP Exam questions & answers How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days How many members must sit on an IRB? - ANSWER-5 How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research What ...

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CCRP Practice Questions 2023 with complete solutions

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Which of the following required elements should be included in a clinical trial protocol?

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CCRP Practice Questions & answers 100% correct

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CCRP Practice Questions Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - ANSWER-PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally ...

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CCRP Exam 2023 with 100% correct answers

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CCRP Exam questions & answers 2023 How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days How many members must sit on an IRB? - ANSWER-5 How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research ...

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Certified Clinical Research Professional (CCRP) Exam 2023 with complete solutions

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Certified Clinical Research Professional (CCRP) Exam When isn't an IND application needed? - ANSWER-IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - ANSWER-FDA Form 1571: -FDA Form 1571 ...

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SOCRA CCRP Exam 2023 with 100% correct answers

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SOCRA CCRP Exam questions & answers 2023 April 30 1996 - ANSWER-ICH GCP Development Date 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 Ma...

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CCRP AACVPR exam 2023 with 100% correct answers

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CCRP AACVPR questions & answers 2023 What influences a persons metabolic rate? - ANSWER-Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - ANSWER-Fat Foods that raise insulin levels have... - ANSWER-added sugar W...

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SOCRA - CCRP (high level) 2023 with 100% correct answers

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SOCRA - CCRP (high level) 2023 Nuremberg Code (1947) - ANSWER-A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - ANSWER-1. voluntary 2. necessary for ...

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