Ich guidelines - 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 ...

A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. - Answer- b. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical research. ...

A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. correct answersb. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical resea...

Good Clinical Practice Course (Medical Clinical Research) Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the primary objective of the International Council for Harmonization (ICH)? a. To ensure global consistency in clinical trials b. To reduce duplication of clinical trials and improve efficiency c. To promote new drug development worldwide d. To establish a single regulatory framework for all countries The ICH Good Clinical Practice (GCP) guidelin...

Good Clinical Practice Questions Latest Update | 2024/2025 | Already Passed What are the three fundamental principles outlined in the Belmont Report? • Autonomy • Compassion • Fairness How can the Principle of Compassion be applied to a research study involving human subjects? • By ensuring that the study maximizes potential benefits and minimizes potential risks to participants. The Belmont Report's principle of compassion includes two core guidelines: (1) do no harm...

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...

Laws - passed by national legislative bodies; establish authority of national regulatory body Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - "current thinking" of regulatory bodies; non-binding ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - developed by an organization (sp...

CRA ACRP Practice Exam Questions w/ explanation 100% Solved A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects - answer1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subjects even if they are unable to identify subjects that meet entry criteria, which can help discriminate sites who are failing to make...

CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does th...

CITI TRAINING SET EXAM QUESTIONS WITH COMPLETE SOLUTIONS How is the ICH governed? - Answer-a Steering Committee Who supports the ICH? - Answer-the ICH Secretariat Who provides the ICH secretariat? - Answer-The International Federation of Pharmaceutical Manufacturers Association (IFPMA) How many seats on the Committee does each of the 6 working groups of ICH have? - Answer-2 who nominates other nonvoting participants to attend ICH steering Committee meetings? - Answer-The observer ...