Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Already Passed

Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Already Passed What are the fundamental principles that guide clinical trials? A set of standards that ensures the credibility of clinical trial data, prioritizes the protection of human subjects, and upholds the highest ethical standards. The International Conference on Harmonization (ICH) is a collaborative effort among regulatory authorities and industry experts from Europe, Japan, and the United States. Its purpose is to harmonize regulatory requirements for pharmaceutical development and ensure a streamlined global approval process. What is the primary objective of ICH? To optimize the use of resources, minimize delays in product development, and ensure that new products meet rigorous standards for quality, safety, efficacy, and regulatory compliance. How do we ensure that clinical trials adhere to Good Clinical Practices (GCPs)? Through a multi-faceted approach involving: * Informed consent: a process that empowers participants to make informed decisions about their involvement in a clinical trial * Institutional Review Boards (IRBs): independent committees that review and approve research protocols to ensure ethical considerations * Clinical Investigators: medical professionals responsible for conducting clinical trials * Sponsors/Monitors: organizations or individuals responsible for overseeing the trial's conduct and ensuring compliance with regulations What does informed consent entail? It is more than just signing a form. It involves a comprehensive process that provides subjects with all necessary information to make an informed decision about participating in a clinical trial. This includes: * Obtaining IRB approval prior to initiating the trial * Securing informed consent before conducting any research-related procedures * Revising consent forms as new information becomes available that may impact subject participation * Presenting information in an understandable manner to study subjects Eight Basic Elements of Informed Consent 1. statement that the study involves research; purpose, duration, procedures, and experimental-only procedures 2. risks and discomforts 3. expected benefits 4. disclosure of alternative procedures 5. confidentiality of subject records/ who can inspect records 6. compensation/medical tx availability if injury occurs 7. Name and # for ppl or offices to contact 8. statement that participation is voluntary and can withdraw at any time w/o penalty Advertising for research subjects - seen as part of informed consent process - irb review is necessary to ensure info is not misleading or coercive - name, address of PI/facility - research purpose