Samenvattingen, Notities en Examens

SOCRA Practice Test Questions With Verified Solutions Which of the following is a disclosure of financial interests form? - answerFDA Form 3455 Which of the following is a certification of financial interest form? - answerFDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - answerFDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - answerInvestigational New Drug Applica...

SOCRA Exam Questions With 100% Correct Answers When isn't an IND application needed? - answerIND 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 -Addi...

SOCRA Exam Questions With 100% Correct Answers Respect for persons, justice, beneficence - answerList the three ethical principles of the Belmont report Experiment that involves a test article and one or more human subjects - does not include experiments which are nonclinical lab studies - answerDefine clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control - answerHuman subject is: Life threatening circumstance...

Biometrics - correct answersA 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 answersAn 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 - correct answe...

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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 ...