312 50 Study guides, Class notes & Summaries

CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024 21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in Clinical ...

NRNP 6566 Final Exam Questions & Answers 2023 Update NRNP 6566 Final Exam Questions & Answers 2023 Update Question 1 Which statement is correct about fluoroquinolones? fluoroquinolones are effective treatment for urinary tract infections and pyelonephritis Fluoroquinolones are recommended treatment in uncomplicated skin infections fluoroquinolones are not associated with tendon rupture fluoroquinolones are never indicated in the treatment of pediatric infections Question 2 A 42...

A study was conducted to see if gender influences the number of alcoholic beverages consumed per day. Which type of classification is this? - correct answer Categorical, categorical (Categorical, quantitative) Quantitative, categorical Quantitative, quantitative Given the following set of numbers: 25, 2.5, -2, and -1 what is the product of the integers? 250 50 100 -2 - correct answer Given the...

April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 Financial Disclosures 21 CFR Part 54 Institutional Review Board 21 CFR Part 56 IND Appli...

HERE IS THE LIST OF THE CHAPTERS: CHAPTER 1. Introduction 1. What is the name under which a Page : 6 CHAPTER 2. GERIATRICS 1. The following is an accurate description of Page : 9 CHAPTER 3. PEDI ATRICS 1. AJ is a 14-dayPage : 13 CHAPTER 4. PALLIATIVE CARE 1. JP is being treated for lung Page : 16 CHAPTER 5. HYPERTENSION 1. A 55-year-old white Page : 20 CHAPTER 6. HEART FAILURE 1. Which of the following finding, Page : 24 CHAPTER 7. ISCHEMIC HEART DISEASE 1. A 50-yearPage : 28 CHAPTER 8. ACUTE CO...

SOCRA CCRP Exam Review Questions and answers, rated A+ FDA Part 11 - -electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - -Food and Drugs, and ICF FDA Part 56 - -IRBs FDA Part 312 - -investigational new drug application FDA Part 812 - -investigational drug exemption FDA Form 482 - -Notice of inspection FDA Form 483 - -Letter of investigational observations/citation of noncompliance that ...

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...

What is the essential difference between an 'Ethical Hacker' and a 'Cracker'? A. The ethical hacker does not use the same techniques or skills as a cracker. B. The ethical hacker does it strictly for financial motives unlike a cracker. C. The ethical hacker has authorization from the owner of the target. D. The ethical hacker is just a cracker who is getting paid. Answer: C Explanation: The ethical hacker uses the same techniques and skills as a cracker and the motive is to find th...

Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). GCP v Declaration of Helinski - ANSWER -GCP lacks moral principles an...

SOCRA Practice Test Questions and Answers Already Passed 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 cor...