Clinical trial phase 1 - Study guides, Class notes & Summaries

ACRP-CP Certification Exam 2024/25 EDITION GUARANTEED GRADE A+ What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain a...

1. Active Pharmaceutical Ingredients (API) or bulk drug substance may be discovered or obtained by: I. Synthetic biotechnology II. Isolation from natural sources III. Serendipitous new drug effect discovery A. I only B. III only C. I and II D. II and III E. I, II and III correct answers E. I, II and III 2. Rx product life cycle phases that involves regulatory submission for additional dosage forms or new therapeutic indications A. Discovery B. Development C. Commercialization D. T...

Clinical Trial- Phase 1 correct answers - Tests drug in healthy individuals - Tests for safety, dosage, and side effects Clinical Trial- Phase 2 correct answers - Tests on larger group of effected individuals - Tests for efficacy and side effects Clinical Trial-Phase 3 correct answers - Tests on new and wider demographic - Tests for long term effectiveness and comparisons with other medications Clinical Trial- FDA Approval correct answers Treatment determined effective and safe for p...

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - correct answer C) You intend to collect blood sampl...

US RAC Review Questions and Answers RAPS Modules 2024 with complete solution In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved dru...

US RAC Review Questions RAPS Modules 2024 with complete solution In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new ...

Define critical inquiry correct answer: purposeful thinking and reflective reasoning to examine ideas, assumptions, principles, conclusions, beliefs, and actions in nursing practice Define EBP and sources of knowledge correct answer: EBP = making clinical decisions based on clinical judgement, patient preference, and the best evidence Sources of knowledge: a. Tradition b. Authority c. Personal experience (empirical knowledge) i. Based on observation and experimentation d. Trial and e...

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinic...

SOCRA Practice Test with 100% Correct Solutions 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...

[COMPANY NAME] [Company address] ACRP PRACTICE EXAM 2022 QUESTIONS AND ANSWERS A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of t...