SOCRA Study guides, Class notes & Summaries

SOCRA (CCRP) Exam Practice Questions and Answers 2024 The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT AND ANSWER-Determining that the...

SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers Which of the following is a disclosure of financial interests form? - CORRECT ANSWER-FDA Form 3455 Which of the following is a certification of financial interest form? - CORRECT ANSWER-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - CORRECT ANSWER-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginnin...

SOCRA Certification Exam Guide 2024 with correct answer Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible...

CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024 21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in Clinical ...

SOCRA Certification Exam Questions and Answers 2024 100% Correct Biometrics - CORRECT ANSWER-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) Closed System - CORRECT ANSWER-An environment in which system access is controlled by persons who are responsible for the content of electronic records that a...

SOCRA CFR/ IND Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+ 5-142 What records must be maintained by investigators for investigational drug supplies? 21 CFR 312.62 Records of drug disposition including dates, quantities, and use by study subjects. 5-150 How must an investigator store investigational drugs which are also controlled substances? 21 CFR 312.69 In a securely locked, substantially constructed cabinet or other enclosure with limited acce...

SOCRA Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+ 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 ...

SOCRA Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+ The Purpose of the IRB is to: Protect the rights and welfare of human subjects in research What is the minimum number of members required by an IRB 5 Which of the following are necessary to waive consent? A.Subject is unable to give consent B.No time or unable to contact next of kin C.Life-Threatening Condition D.No other treatment available E.All of the above all of the above This form is...

SOCRA Final Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+ Biometrics Correct Answer: 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) Closed System Correct Answer: An environment in which system access is controlled by persons who are responsible for the content of...

SOCRA Certification Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+ Nuremberg Military Tribunals: The Doctor's Trial War crimes and crimes against humanity: to perform medical experiments upon concentration camp prisoners and other living human subjects, without their consent, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts Nuremberg Military Tribunals: The Doct...