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Violence and Victimization Trauma Informed Care Questions and complete Answers 2023/2024

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Violence and Victimization Trauma Informed Care Questions and complete Answers 2023/2024 What is defined as the "personal experience of violence and victimization, including sexual abuse, physical abuse, severe neglect, loss domestic violence, and/or the witnessing of violence, terrorism, or disasters?" - correct answer Trauma Trauma-Informed Care: - correct answer Incorporates proven practices into current operations to deliver appropriate services., Acknowledges the role that violence an...

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Women's Health Fetal heart rate Well-being Assessment Questions and Answers 2023/2024

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Women's Health Fetal heart rate Well-being Assessment Questions and Answers 2023/2024 Purpose of Fetal Monitoring - correct answer *Assessment of fetal well-being *Antepartum *Intrapartum *Must be done by a licensed and trained HCP Characteristics to Assess Fetal Status - correct answer *Baseline (fetal heart rate)FHR *Presence of accelerations *Baseline FHR variability *Presence of decelerations *Trends over time Assessment of FHR: During Labor (and prior to) - correct answer Dur...

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ACRP CCRC Final Certification Exam Review Practice Questions and Answers 2023/2024

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ACRP CCRC Final Certification Exam Review Practice Questions and Answers 2023/2024 What are expected or possible consequences of over-estimation of recruitment potential? - correct 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 stopped because of lack of budget What should be the first consideration when conducting a clinical ...

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CCRP AACVPR Macronutrients Exam practice Questions and verified Answers 2023/2024

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CCRP AACVPR Macronutrients Exam practice Questions and verified Answers 2023/2024 What influences a person’s metabolic rate? - correct answer Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - correct answer Fat Foods that raise insulin levels have... - correct answer added sugar When feeling stressed, you may feel relief after eating a piece of chocolate because... - correct answer it will raise dopamine level...

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CCRP Definitions (21 CFR 50) Human subject Protection requirements Questions and Answers 2023/2024

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CCRP Definitions (21 CFR 50) Human subject Protection requirements Questions and Answers 2023/2024 21 CFR 50 - correct answer Protection of Human Subjects Sponsor - correct answer a person who initiates a clinical investigation, but who does not actually conduct the investigation Sponsor-investigator - correct answer an individual who both initiates and actually conducts (alone or with others) a clinical investigation Human subject - correct answer an individual who is or becomes a par...

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CCRP Joints and Muscles Terms and phases Questions with Certified answers 2023/2024

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CCRP Joints and Muscles Terms and phases Questions with Certified answers 2023/2024 Shoulder Flexion Normal ROM - correct answer 30-60 Shoulder Extension Normal ROM - correct answer 160-170 Shoulder Abduction Normal ROM - correct answer 40-50 Shoulder Adduction Normal ROM - correct answer 40-50 Shoulder Internal Rotation Normal ROM - correct answer 40-50 Shoulder External Rotation Normal ROM - correct answer 40-50 Elbow Flexion Normal ROM - correct answer 20-40 Elbow...

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CCRP ICH GCP and FDA Exam Guide Questions and complete Answers 2023/2024

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CCRP ICH GCP and FDA Exam Guide Questions and complete Answers 2023/2024 Who was tried in the Nuremburg Military Tribunals and why? - correct answer 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? - correct answer After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convict...

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CCRP IRB, ICH and FDA Practice Guide Exam Question and answers 2023/2024

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CCRP IRB, ICH and FDA Practice Guide Exam Question and answers 2023/2024 How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days How many members must sit on an IRB? - correct answer 5 How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 2. Risks are reasonable in relati...

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CCRP Patient Health status Assessment Exam Review Questions and Complete Answers 2023/2024

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CCRP Patient Health status Assessment Exam Review Questions and Complete Answers 2023/2024 Assessment - correct answer an objective evaluation or appraisal of an individual's health status, including acute and chronic conditions How does an assessment gather information? - correct answer through collection of data, observation, and physical examination What type of assessment? •Gather information about the patient from available sources such as medical records or reports from diagnostic...

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CCRP ICH-GCP and ICF Exam Practice Guide Questions and Verified Answers 2023/2024

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CCRP ICH-GCP and ICF Exam Practice Guide Questions and Verified Answers 2023/2024 Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct a...

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CCRP SOCRA CFR, ICH FDA Practice Exam Questions with Guaranteed Answers 2023/2024

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CCRP SOCRA CFR, ICH FDA Practice Exam Questions with Guaranteed Answers 2023/2024 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator - correct answer C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - correct answer B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a p...

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CCRP SoCRA 21 CFR PARTS Exam Questions and certified Answers 2023/2024

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CCRP SoCRA 21 CFR PARTS Exam Questions and certified Answers 2023/2024 21 CFR Part 11 - correct answer Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - correct answer Electronic Records 21 CFR Part 11 Subpart C - correct answer Electronic Signatures 21 CFR Part 50 - correct answer Protection of Human Subjects 21 CFR Part 50 Subpart B - correct answer Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - correct answer Additional Safeguards for Children...

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CCRP FDA and IRB Timelines Questions with complete Answers 2023/2024

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CCRP FDA and IRB Timelines Questions with complete Answers 2023/2024 5 Working Days Report to FDA - correct answer Notice of change to the IDE 5 Working Days Report to FDA, Investigators and IRBs - correct answer Termination of study after determination due to a UADE that presents an unreasonable risk 5 working days to Sponsor - correct answer Investigator to notify sponsor regarding IRB withdrawal of approval 5 Working Days to FDA, Other participating IRBs and PIs - correct answer Spo...

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CCRP IDE, IRB and FDA Duration Requirement Exam Practice Guide Questions and Answers 2023/2024

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CCRP IDE, IRB and FDA Duration Requirement Exam Practice Guide Questions and Answers 2023/2024 Notice of change to the IDE - correct answer 5 Working Days Report to FDA Investigator to notify sponsor regarding IRB withdrawal of approval - correct answer 5 working days Investigator to report to sponsor and IRB use of a device without informed consent (emergency use) - correct answer 5 working days to Sponsor and IRB Sponsor to notify of IRB withdrawal of approval - correct answer 5 Work...

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CCRP 21 CFR and FDA Forms and Documentation Requirement Questions and Answers 2023/2024

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CCRP 21 CFR and FDA Forms and Documentation Requirement Questions and Answers 2023/2024 21 CFR 50 - correct answer Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - correct answer 50.25 Elements of Informed Consent 21...

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CCRP Sponsor and Approved IDE Practice Exam Guide Questions and Answers 2023/2024

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CCRP Sponsor and Approved IDE Practice Exam Guide Questions and Answers 2023/2024 Sponsor - correct answer An entity that initiates a clinical investigation 3 primary responsibilities of an investigator - correct answer 1. Oversees the conduct of the clinical trial 2. Protects the rights, safety, and welfare of subjects 3. Control the use of investigational product FDA Form 1572 - correct answer Statement of Investigator Form - Signed Declaration from investigator that he/she will comply ...

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Certified Clinical Research Professional (CCRP) FDA- IND Application Exam practice Questions and Answers 2023/2024

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Certified Clinical Research Professional (CCRP) FDA- IND Application Exam practice Questions and Answers 2023/2024 When isn't an IND application needed? - correct 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) - correct answer FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing informati...

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Certified Clinical Research Professional (CCRP) Final Board Certification Questions and Answers 2023/2024

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Certified Clinical Research Professional (CCRP) Final Board Certification Questions and Answers 2023/2024 The minimum number of IRB members - correct answer 5 Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer 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 responsibility for ensuring that the investigator understands a clinical trial lies with - correct a...

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SOCRA - CCRP FDA and HHS Regulations and Disclosures Practice Exam Questions and Answers 2023/2024

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SOCRA - CCRP FDA and HHS Regulations and Disclosures Practice Exam Questions and Answers 2023/2024 Nuremberg Code (1947) - correct 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 - correct answer 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk ass...

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SOCRA (CCRP) Belmont report Exam Practice Questions and Ascertained Answers 2023/2024

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SOCRA (CCRP) Belmont report Exam Practice Questions and Ascertained Answers 2023/2024 The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - correct answer Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - correct answer Determ...

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