Socra exam Study guides, Class notes & Summaries

SOCRA Exam Questions And Answers Electronic signatures are currently accepted for any and all records, paper or electronic form. True or False? - ANS False. The general provisions for electronic 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...

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | 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 pr...

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...

Which of the following is a disclosure of financial interests form? Correct Answer: Which of the following is a certification of financial interest form? Correct Answer: If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: Correct Answer: This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Correct Answer: Investigational New Drug Application In the top right corner, form have OMB number. ...

SOCRA EXAM QUESTIONS AND ANSWERS

SOCRA Exam Prep Questions And Answers | 2023/2024 Tests SOCRA Exam Prep Questions And Answers | 2023/2024 Tests

CCRP SOCRA Exam | 100% Correct Answers | Verified | Latest 2024 Version

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - 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 consider the...

SOCRA Exam Questions And Answers With Verified Solutions 2023/2024

CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As