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...

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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...

SOCRA Practice Test with 100% Correct Solutions 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 submitted by sponsor to the FDA prior to the beginning of the drug trial - Answer-Investigational New Drug Application...

SOCRA CFR study sets, IND Set test 2024 with 100% Correct Answers 5-142 What records must be maintained by investigators for investigational drug supplies? 21 CFR 312.62 -Answer-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 -Answer-In a securely locked, substantially constructed cabinet or other enclosure with limited access to prevent thef...