Guides d'étude, Notes de cours & Résumés

SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presen...

SOCRA Practice Test {2024} Questions with Correct Answers Graded A+ Which of the following is a disclosure of financial interests form? - Answer - FDA Form 3455

SOCRA Practice Test Questions With Verified Solutions Which of the following is a disclosure of financial interests form? - answerFDA Form 3455 Which of the following is a certification of financial interest form? - answerFDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - answerFDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - answerInvestigational New Drug Applica...

SOCRA Exam Questions With 100% Correct Answers When isn't an IND application needed? - answerIND 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 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Addi...

SOCRA Exam Questions With 100% Correct Answers Respect for persons, justice, beneficence - answerList the three ethical principles of the Belmont report Experiment that involves a test article and one or more human subjects - does not include experiments which are nonclinical lab studies - answerDefine clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control - answerHuman subject is: Life threatening circumstance...

Biometrics - correct answersA 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 - correct answersAn 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 - correct answe...

SOCRA Exam Questions with correct answers newest review

Certified Clinical Research Professional (CCRP) /SOCRA Exam 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 information -Pharmacology/toxicology -Previous human ...

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members 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 Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSW...

CCRP SOCRA Practice Exam 2024 Final questions and correct answers 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 potential for serious...