Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. 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. ICH E7: Studies in Support of Special Populations: Geriatrics Questions and Answers 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. ICH E Choice of Control Group and Related Issues in Clinical Trials PDF - 93KB 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. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.
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It is strongly recommended you download this document to your own computer and open it from there. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial. The NHMRC is specifically required to issue guidelines for the conduct of medical research and ethical matters related to health. Compliance with the National Statement is a condition of approval for the conduct of a clinical trial. The responsibilities, composition, function, operations, procedural and record keeping requirements for Human Research Ethics Committees in Australia are set out in the National Statement.
Section 4. Section 5. However, in Australia, the overriding consideration for trial sponsors with respect to record retention is the issue of product liability and the potential need for sponsors of products to produce records at any time during, and possibly beyond, the life of a product in the event of a claim against the sponsor as a result of an adverse outcome associated with the use of the product.
Trial sponsors should refer to the guidance published by the NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods. Category:Clinical trials.
U.S. Food and Drug Administration