Socra ccrp practice - Study guides, Class notes & Summaries

CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 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 ️ C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 ️ 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 risk to the heal...

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SOCRA CCRP Practice Test with complete Solutions | Latest 2023/2024 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 Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial ️ Investigational New Drug Applicat...

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 the CAPA process. What is quality assurance? - correct answer Planned and systematic activities necessary to ensure that the trial is performed and the data are generated and in compliance with GC...

CCRP SOCRA Exam - Practice Exam 1 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 C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 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 risk to the health, safety, or welfare of a subject B) P...

CCRP SOCRA Exam - Practice Exam #1

SOCRA CCRP EXAM 2024 NEWEST 2 VERSIONS AND PRACTICE EXAM QUESTIONS 400 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT) /ALREADY GRADED A+