![]() ![]() The purpose of this document is to offer a systematic approach to quality risk management. This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of clinical trials, and the issue of whether a trial could have detected a difference between treatments when there was a difference (assay sensitivity). This question and answer (Q&A) document is intended to clarify key issues. This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. ![]() This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors. The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review. ICH Guidance Documents This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. ![]() The objective of this ICH GCP Guideline is to provide a unified standard for the European. GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline. ![]() Ich Gcp E9 Guidelines Filetype Pdf Average ratng: 5,7/10 8517votes ![]()
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