Socra exam - Study guides, Class notes & Summaries

SoCRA CERTIFICATION EXAM AND PRACTICE EXAM 2023-2024 ACTUAL EXAMS 400 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS) | ALREADY GRADED A+

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 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, s...

SOCRA CCRP EXAM 2024/ACTUAL EXAM 120 QUESTIONS AND CORREECT VERIFIED ANSWERS/A+ GRADE

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...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Answer - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will con...

SOCRA EXAM 2024 -25 WITH 100% ACCURATE SOLUTIONS Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - correct answer False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records m...

Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... 00:27 01:29 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ... This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application In the top rig...