Irb test exam - Study guides, Class notes & Summaries

IRB Final Exam Study Test. What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)? Honesty, Trust, Respect Informed consent, IRB review, Research Integrity Respect for Persons, Beneficence, Justice Protections for Pregnant Women, Prisoners, Children - CORRECT ANSWER Respect for Persons, Beneficence, Justice An "autonomous person" is someone who: Has reached the legal age to provide informed consent in the State. ...

RAC Practice Exam Questions and Answers Rated A+ A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. C. 30 calendar days. Serious injury must be reported within 30 days. 21 CFR 803.50(a). Und...

SoCRA Certification Exam Complete Questions with Graded A+ Answers Biometrics 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 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...

Biometrics 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 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) Digital Signature An electronic signature based upon cryptograph...

Florida MPJE Exam Questions and Answers 100% Pass Sherman Antitrust Act - Correct Answer ️️ -This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act - Correct Answer ️️ -This act states: No adulterated or misbranded drugs in interstate commerce Adulteration - Correct Answer ️️ -Gross - Think inside the capsule Misbranded - Correct Answer ️️ -Improperly labeled - think outside the bottle F...

CITI Training Exam Test with Verified Solutions 1. Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? 2. According to the Belmont Report, the moral require- ment that there be fair outcomes in the selection of research subjects, expresses the principle of: 3. The researcher's failure to protect research subjects from deductive disclosu...

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 FDA Exam review Questions and answers, Verified/ If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article - -5 days If an article is used in an exempt way, this should be reported to the IRB in X after the use of the article - -5 days Emergency use of a test article must be reported to the IRB in X time. Any subsequent use is subject to...

ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - answer IB When considering participation in a study, the investigator should determine if he/she: -answer sees enough patients who would qualify for the study. When would an impartial witness be needed during the consent process for an illiterate subject? - answer To observe...

RAC Practice Exam 1 Questions and Answers New Version 2024 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic re...