Human Subjects Research (HSR) content is organized into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). They are intended for anyone involved in research studies with human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards
What is Good Clinical Practice (GCP)? GCP is a set of 13 principles that help ensure that quality research is being conducted and that participants in research are protected. The principles were established by the International Conference on Harmonization (ICH) in 1990 to define the minimum standards expected for clinical trials involving
Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. Basic courses provide in-depth foundational training. We also offer completely fresh content in Refresher courses for retraining and advanced learners.
An IRB/IEC is an independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and
ICH GCP. Good Clinical Practice (GCP) is an international standard set for conducting, inventing, recording, and reporting clinical trials which may involve humans as participants. It's very important to obey this standard as it offers the public the confidence that the trial subjects' rights, safety, and well-being are protected, and that data
ICH E6 describes standards that apply to: Investigators, sponsors, and Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs). ICH topics and guidelines fall into four main categories: Quality, Safety, Efficacy, Multidisciplinary. A primary purpose of the ICH E6 guideline is to:
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what is gcp in research