Ich e6 - Study guides, Class notes & Summaries

Goals of ICH correct answersTo standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing ICH E6 has become correct answersThe international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs Good Clinical Practice (GCP) correct answersenhances protection of study subjects and the integrity of ...

ICH E6 (R2) - Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Graded A+ What essential aspects should an IRB/IEC safeguard for all trial participants? Choose from the following options: a) Confidentiality, integrity, and accountability b) Rights, safety, and well-being b) Rights, safety, and well-being What documents should an IRB/IEC obtain prior to reviewing a clinical trial? Select from the following options: a) Investigator's personal reco...

How long should essential documents be retained? : At least 2 years after the last approval of the marketing application in an ICH region; until there are no pending marketing applications or at least 2 years from formal discontinuation of the clinical development of an IP. Who should make available for direct access all requested trial-related records and to whom? : Investigator to provide direct access to monitor, auditor, IRB and regulatory authorities To whom must the investigator su...

ICH stands for correct answersInternational Council for Harmonisation Regulatory Reviewers focus on correct answersFocus on study validity and results- want to see GCP used to produce high quality data based on the protocol Inspectors focus on correct answersFocus on study conduct and oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration correct answersTrue What is the missi...

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

ICH stands for - Answer- International Council for Harmonisation Regulatory Reviewers focus on - Answer- Focus on study validity and results- want to see GCP used to produce high quality data based on the protocol Inspectors focus on - Answer- Focus on study conduct and oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration - Answer- True What is the mission of ICH? - Answer-...

Goals of ICH correct answersTo standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing ICH E6 has become correct answersThe international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs Good Clinical Practice (GCP) correct answersenhances protection of study subjects and the integrity of ...

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 physiological function Adverse Event (AE) - Answer Any untoward medical occurrence in a patient or clin...

In ICH-GCP an audit is defined as A) A systematic and independent examination of trial-related activities and documents B) An investigation intended to discover and verify the clinical effects of an investigational product C) Official review of document facilities records and any other resources D) Overseeing the progress of a clinical trial correct answersA) A systematic and independent examination of trial related activities and documents In ICH-GCP an inspection is defined as ...

Good Clinical Practice Guide Questions with correct Answers 2024 The ICH E6 guideline should be followed when: A. Generating clinical trial data that are intended to be submitted to regulatory authorities B. Conducting studies under a U.S. Investigational New Drug (IND) application or Investigational Device Exemption (IDE) C. Generating quality improvement and quality assurance data D. Conducting device studies under a Canadian Investigational Testing Authorization (ITA) A. Generating cl...