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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...

Respect for persons, justice, beneficence List 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 Define clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control Human subject is: Life threatening circumstances deem use of test article necessary, inability to communicate or ...

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 Application (1571) In the top right corner, form have OMB number. What does it stand for? Of...

When isn't an IND application needed? 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) -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 abuse potential)

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...

SoCRA Certification with correct questions and answers Exam update.

CCRP SOCRA PRACTICE QUESTIONS AND ANSWERS LATEST UPDATE EXAM.

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SOCRA with 300+ Questions and answers complete solution Exam.