Система федеральных образовательных порталов. Каталоги, библиотеки, форумы, законы, документы, стандарты.
The intent of this document is to define the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6) that TransCelerate has identified as necessary to enable the mutual recognition of GCP training.
1. Introduction of PMDA 2. “Good Clinical Practice” in Japan.
1.24 Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity...
Мы разработали три программы тренингов по ICH GCP
1. The primary purpose of Good Clinical Practice training is to enable those being trained to comply with the regulations and guidelines that apply to clinical research. 2. It is not possible to comply with GCP if one does not know what the GCP regulations and guidelines require.
This list provides a summary of investigator responsibilities required for compliance with ICH Good Clinical Practice (GCP) Guidance. If the investigator has agreed to conduct the research in compliance with ICH GCP E6...
Good Clinical Practice. 1) GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
Key Activities in a Clinical Trial. The Process Approach. Brief History of GCP (U.S. and international) Goals and Principles of GCP Roles and Responsibilities Under GCP.
• The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices • Overview of New Drug Development • Overview of ICH GCP • ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations • Conducting...
Significant updates to the ICH GCP guidelines, currently pending approval in draft form, not only harmonise the conduct of clinical trials, in light of various regulatory reforms by ICH member states, but also establish novel forward-thinking standards.