Clinical investigations - Study guides, Class notes & Summaries

CITI Training 134 QUESTIONS Graded A+ Solved 2023 What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant...

Retrospective Integration - ANSWER-Designing education-based strategies to mitigate identified risks Clinical transformation care that is consistently (6 things).... - ANSWER-Safe. Effective. Patient Centered. Timely. Efficient. Equitable. Safety - ANSWER-Prevention/moderation of hazard (induced harm) Unsafe Acts - ANSWER-An act that is not safe for an employee. Human error. (slips, lapses, mistakes, violations) The Safety Assessment Code (SAC) Matrix - ANSWER-When a severity categor...

WGU C426 Healthcare Values and Ethics Rated A+ Normative Ethics Attempt to determine what moral standards should be followed so that human behavior and conduct may be morally right. Consequential Ethics Theory of ethics emphasizes that the morally right action is whatever action leads to the maximum balance of good over evil. - What will be the effects of each course of action? - Will they be positive or negative? - Who will benefit? - What will do the least harm? Utilitarian Ethics The conce...

RENAL Notes and Questions (100 %Score) Latest updated 2024/2025 Comprehensive Questions and A+ Graded Answers | 100% Pass

Urinary/Renal Function Questions (100 %Score) Latest updated 2024/2025 Comprehensive Questions and A+ Graded Answers | 100% Pass

1. What is Good Clinical Practice (GCP) ANS An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects 2. What does Good Clinical Practice assure ANS Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 3. What is the objectiv...

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. Wh...

Chapter 1 Perspectives on Maternal and Child Health Care 1 . The United States ranks 50th in the world for maternal mortality and 41st among industrialized nations for infant mortality rate. When developing programs to assist in decreasing these rates, which factor would most likely need to be addressed as having the greatest impact? A) Resolving all language and cultural differences B) Assuring early and adequate prenatal care C) Providing more extensive womens shelters D) Encoura...

number of interviews/40 year career correct answers 150k % of dx made on history alone correct answers 82% % of dx changed after investigations or physical exam correct answers 9% About how long does it take before physicians interrupt patients (females and males)? correct answers 18 (M) to 23 (F) seconds why is communication important in medicine? correct answers improved ability to deal with emotional situations, increased professional satisfaction, 80% of malpractice claims are du...

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | 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 pr...