Socra Study guides, Class notes & Summaries

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...

Biometrics - 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 - ANSWER 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 - ANSWER An electronic signatur...

When isn't an IND application needed? - 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) - 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 research/literature information -Additional information (drug dependence and a...

SOCRA TESTS 2024 COMBINED QUESTIONS AND ANSWERS 100% CORRECT;SOcRA test bank

SOCRA CERTIFICATION EXAM 2024 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 for the content of the elec...

SOCRA EXAM 2024 -25 WITH 100% ACCURATE SOLUTIONS Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - correct answer False. The general provisions for electeonic 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 m...

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...

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 (1571) In the top right corner, form hav...