Socra exam Study guides, Class notes & Summaries

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...

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...

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...

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...

MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024 5 ️ The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained ️ 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 ️ The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a s...

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...

2023/2024 SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE 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 consent What was the outcome of the Nuremburg Military Tribunals? Correct Answer: After 140 days of proceedings with testimony of 85 witnesses and submission of...

SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine - ANSWER Electronic Records Electronic records must use secure, computer generated, time-stamped audit trail...