Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2023 Update | 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 presen...

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...

Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024 When isn't an IND application needed? - CORRECT ANSWER-IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - CORRECT ANSWER-FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human ...

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-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 - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSW...

CCRP SOCRA Practice Exam 2024 Final questions and correct answers 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 - CORRECT ANSWER-C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - CORRECT ANSWER-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...

SOCRA Actual Certification Exam 2024 questions and answers A-graded Electronic Records - CORRECT ANSWER-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 Electronic Records - Audit Trail - CORRECT ANSWER-Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date...