Btech GCP Quiz 8-9 Latest Update | 100% Verified

Btech GCP Quiz 8-9 Latest Update | 100% Verified Q 1 Good Clinical Practices (GCP) are global ethical and scientific quality standards used to conduct, document, and report human clinical trials. These standards ensure the protection of trial participants' rights, safety, and well-being. Where can you find GCP regulations and guidelines? ICH E6, 21 CFR part 56, 21 CFR part 50, 21 CFR part 46 Not 21 CFR part 96 Which principle aligns with GCP according to ICH (International Conference on Harmonization) guidelines? - Accurate, maintained, and confidential records - Scientifically sound study design - Adherence by investigators to approved clinical trial protocols - Manufacture of clinical trial supplies according to cGMP regulations - The health benefits for patients must outweigh the risks Not Risks to a patient’s health must greatly outweigh benefits What is correct about an Investigational New Drug Application (IND)? - There is a typical 30-day wait after filing an IND with the FDA before a trial sponsor can start a clinical trial - It is outlined in CFR21 Part 312 - The IND application is also referred to as FDA form 1571 - IND approval permits the legal interstate and international movement of unapproved drugs - It is submitted by the trial sponsor Not Submitted by the principal investigator In which phase of clinical trials is the drug's safety and efficacy tested in a large group of volunteers, possibly several thousand, who have the condition being treated? Phase III Who is eligible to submit an IND to the FDA? All of the following may submit an IND - A pharmaceutical company - An individual researcher - Institutions such as MD Anderson or Baylor College of Medicine - Organizations such as the Susan G. Komen Breast Cancer Foundation What is true about ICH? (international Conference on Harmonization - Maintains a forum for regulatory agencies in US, Europe, and Japan - Develops common technical requirements for registration of pharmaceuticals for human use - Facilitates the timely introduction of new drug products into the global marketplace - GCP guidelines are covered under ICH