Ich e6 - Study guides, Class notes & Summaries

ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025 A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? a. The benefits section should be left out of the ICF, as it is not applicable. b. Wording indicating that there is no expected benefit should be included. c. A section on the benefits of clinical research in general should be added. d. A descrip...

ACRP CCRC Exam Prep Questions and Verified Answers What are expected or possible consequences of over-estimation of recruitment potential? ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? ANSWER Subject welfare When is t...

ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11) with Complete Ans Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of phys...

ACRP CCRA Exam Prep Questions and Answers 100% Pass Phase I Trial AKA Human Pharmacology Phase I Trial -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA Therapeutic Exploratory Phase II Trial -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therape...

ACRP-CP Exam Review(Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated 100% Correct!!

Good Clinical PracticeWhich of the following are the three principles included in the Belmont Report? - correct answer • Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer • Determining that the study has maximized benefits and minimized risks. * The Belmont Report's principle of beneficence includes the two general rules as complementary expres...

ICH E6 - GCP EXAM WITH QUESTIONS AND ANSWERS ...

ACRP Boot camp Exam Questions and Answers Already Passed 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 a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Post market device registries d. outcome and health services research d Who is ultimately responsible for all aspects of the research conducted at a site? ...

International Council for Harmonisation ICH E6 Latest Exam With Questions And Accurate Answers...

CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they mus - Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical record The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial pro...