SOCRA CCRP Exam Questions and Answers 2024/2025 (package deal)

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 m...

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...

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 ...

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?...

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 consen...

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 ans...

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-inve...

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...

SOCRA CCRP Competency study guide Exam test questions with approved Answers 2024/2025 What determines the causality of an adverse event? - correct answer The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - correct answer Quality ...

CCRP SOCRA Certification Proficiency knowledge test Exam Questions and certified Answers 2024/2025 Define dead fetus - correct answer a fetus that exhibits neither heartbeat, respiratory activities, muscle movements or pulsations of the umbilical cord Neonate - correct answer newborn Nonvia...

CCRP SOCRA Learning checks Exam Questions with complete Answers 2024/2025 Supination -correct answer External rotation of the limb, such tahat the pad surface of the paw faces medically Pronation -correct answer Internal rotation of the limb, such that the pad of the surface of the paw faces l...

CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025 Clinical Safety constitutes what ICH efficacy guidelines? - correct answer E1-E2F Good Clinical Practice constitutes what ICH efficacy guidelines? - correct answer E6 (ICH E6 GCP 1.21) ...

CCRP SOCRA Preparedness baseline Exam knowledge Questions with Expertly written solution 2024/2025 What FDA regulations govern UADE reporting? - correct answer 21 CFR 812 (.15 and .3) What regulations govern research with pregnant women and fetuses? - correct answer 45 CFR 46 Subpart B What...

CCRP SOCRA Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025 What is the purpose of the IRB/IEC? - correct answer Safeguard the rights, safety, and well-being of all trial subjects Which of the following should the investigator do FIRST if a Serious Adverse Event...

CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - correct answer C) 3500 Reminder: 3500 is for voluntary; 3500A is for ...

CCRP SoCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025 FDA Form 3454 - correct answer Certification - Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 - correct answer Disclosure - Financial Interests and Arrangements of Clinica...

CCRP SOCRA Focused on timelines Exam Review Questions and A Level Marking Scheme Latest 2024/2025 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 ua...

CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025 An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than _ per year. - correct answer once Research may receive appro...

CCRP SOCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025 In an SR study, who must approve the IDE application prior to the study start? - correct answer FDA In an NSR study, do sponsors and IRB's have to report to FDA prior to the study starting? - correc...

CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025 Minimal risk - correct answer the likelihood of harm is no greater than that encountered in daily life or during routine PE IDE (Investigational D...

SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025 Per ICH E8, methods used to evaluate patient usage of the test drug should be what? - correct answer Specified in the protocol and actual usage documented The study subject asks y...

SOCRA - CCRP Problem Solving Exam Questions and With Distinction level Marking scheme updated 2024/2025 Jewish Chronic Disease Hospital study (1963) - correct answer Live cancer cells were injected into 22 cognitively impaired patients. National Research Act (1974) - correct answer Congress pa...

SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025 What is a CAPA?? - correct answer Corrective and Preventative Action. It is a process to identify root cause of issues or problems and actions to resolve them.. CAPA plan is a document that describes...

SOCRA CCRP Indispensable Study Assessment Guide Exam Questions with all Questions Accurately Answered Updated 2024/2025 Quality Control (QC) focuses on what? - correct answer identification and correction Quality Assurance (QA) focuses on what? - correct answer prevention Corrective And Pre...

SoCRA CCRP Test Exam Review Questions with all Answers verified for accuracy Updated 2024/2025 Viable - correct answer as it pertains to the neonate, means being able after delivery to survive. Human Subject - correct answer A living individual about whom an investigator conducting research ob...