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CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle $40.38   Add to cart

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CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle

CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle

24 items

CCRP Exam Quiz Questions with 100% Correct Solutions Rated A+

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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? ...

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Certified Clinical Research Professional (CCRP) Exam Questions with Correct Solutions| Rated A+

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When isn't an IND application needed? - 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) - FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigato...

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CCRP Exam Prep Exam Questions with Correct Solutions| Rated A+

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Who was tried in the Nuremburg Military Tribunals and why? - Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? - After 140 days of p...

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SoCRA Certification Exam Questions with Correct Solutions Graded to Pass

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Biometrics - A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - An environment in which s...

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CCRP Exam Prep Questions with Correct Solution| Graded to Pass

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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? ...

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CCRP SOCRA Exam Questions with 100% Correct Solutions

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SAE - Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - A document that states that the elements of informed consent have be...

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CCRP Examination Questions with 100% Correct Solutions

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21 CFR 11 - Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Re...

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CCRP AACVPR Test Questions with 100% Correct Answers

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What influences a persons metabolic rate? - Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - Fat Foods that raise insulin levels have... - added sugar When feeling stressed, you may feel relief after eating...

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CCRP Test Questions with Correct Solutions Graded to PASS

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Year/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essentia...

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SOCRA CCRP Certification Exam Questions with 100% Correct Solutions| Graded A+

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Nuremburg Code - The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - 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 disabl...

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SOCRA CCRP Exam Questions with Correct Solutions| Graded A+

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April 30 1996 - ICH GCP Development Date Quality - ICH Q Efficacy - ICH E Safety - ICH S Multidisciplinary - ICH M guidance for industry, consolidated guideance - ICH E 6 Clinical Safety Data Management Definitions and Standards - ICH E2A Safety pharmacology...

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CCRP SoCRA Exam Questions with 100% Correct Solutions Graded to PASS

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21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Sub...

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SOCRA CCRP Certification Questions with 100% Correct Answers

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CFR Title 21: Part 11 - Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -wh...

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MEGA SOCRA CCRP Exam Content with Questions with Correct Answers

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5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor The responsibility for e...

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SOCRA CCRP Test Questions with Correct Solutions | Graded A+

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Contract Research Organization - A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary...

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SOCRA - CCRP (high level) Quiz Questions with 100% Correct Solutions| Rated A+

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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. a...

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SOCRA Exam Questions with Correct Solutions| Rated A+

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Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ...

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CCRP Practice Questions with 100% Correct Answers | Graded A+

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

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SOCRA Practice Test Questions with 100% Verified Solutions

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Which of the following is a disclosure of financial interests form? - FDA Form 3455 Which of the following is a certification of financial interest form? - FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA ...

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SOCRA Practice Test Questions with Correct Solutions| Rated A+

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Which of the following is a disclosure of financial interests form? - FDA Form 3455 Which of the following is a certification of financial interest form? - FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA ...

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CCRP Exam Practice Test Questions with 100% Correct Answers

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Shoulder Flexion Normal ROM - 30-60 Shoulder Extension Normal ROM - 160-170 Shoulder Abduction Normal ROM - 40-50 Shoulder Adduction Normal ROM - 40-50 Shoulder Internal Rotation Normal ROM - 40-50 Shoulder External Rotation Normal ROM - 40-50 Elbow Flexion Normal...

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SOCRA CCRP Exam Questions with 100% Verified Answers| Rated A+

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Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Appl...

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SOCRA certification: Class Quizzes Week 1-5 Questions with 100% Correct Solutions

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The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - Australia, Canada, the Nordic countries and th...

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SoCRA Certification Exam Questions with Correct Solutions Graded A+

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Biometrics - A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - An environment in which s...

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