Gcp review practice test - Study guides, Class notes & Summaries

ICH GCP REVIEW PRACTICE TEST CORRECTLY ANSWERED. FDA - CORRECT ANSWER Food and Drug Administration ICH - CORRECT ANSWER International Conference of Harmonization - homogenized regulations in many drug markets including the US, EU, and Japan. GCP - CORRECT ANSWER Good Clinical Practice Bioavailability - CORRECT ANSWER The degree to which a drug is absorbed or becomes available to a specified location within the body Clinical Trial - CORRECT ANSWER Any study, utilizing human subje...

GCP REVIEW PRACTICE TEST . Which of the following is an important component of drug accountability? - CORRECT ANSWER Drug shipping and disposition records Who has ultimate responsibility for an investigational product? - CORRECT ANSWER Investigator Investigational product dispensing or administration information for the sponsor is recorded on the: - CORRECT ANSWER Case report form The packaging of investigational drugs should ideally: - CORRECT ANSWER Be designed to help with subje...

SoCRA Certification Exam 2023 with complete answers Biometrics A 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 An 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) Digi...

SOCRA CCRP COMPLETELY VERIFIED EXAM DETAILED QUESTION & ANSWERS 100% GUARANTEED PASS EXAM.REVISED. An adverse reaction, the nature or severity of which is not consistent with the applicable product information (investigator's brochure) UADR Sponsor-Investigator An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. ...

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...

CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set Clinical Trial process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Clinical event, measurable indicator, subject reported response Brainpower Read More Feasibility of a Study Assessment of resource needs, regulator requirements, and potential level of risk of ha...

Citi Training GCP and Refresher Review Practice Test 2024. Which of the following defines phase I research as it relates to non-clinical and other phases of research: - CORRECT ANSWER Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - CORRECT ANSWER 20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers...

[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...

MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 5 - correct answer The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - correct answer The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a ...

You overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? - a. That's right; GCP are very rigorous rules that every researcher must follow - b. That's not quite right, because GCP is really more about the behavior of participants...NOT about the behavior of researchers - ...