Socra - Study guides, Class notes & Summaries

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...

SOCRA CERTIFICATION EXAM QUESTIONS AND CORRECT ANSWERS VERIFIED BY EXPERTS |ACCURATE ACTUAL EXAM WITH FREQUENTLY TESTED QUESTIONS |ALREADY A GRADED |GUARANTEED PASS |LATEST UPDATE

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...

SOCRA Practice Test 2024/25 Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455 This form is s...

SoCRA Certification Exam 2024 A 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) - ANSWER Biometrics An 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) - ...

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...

SOCRA CCRP EXAM 2024 WITH 100% CORRECT ANSWERS April 30 1996 - correct answer ICH GCP Development Date Quality - correct answer ICH Q Efficacy - correct answer ICH E Safety - correct answer ICH S Multidisciplinary - correct answer ICH M guidance for industry, consolidated guideance - correct answer ICH E 6 Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A Safety pha

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...