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United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
An IDE allows an investigational device to be used in a clinical study in order to collect safety and/or performance data, typically in support of a marketing application. The studies must be conducted under the principles of medical device Good Clinical Practices (GCP). The GCP refer to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations address the following important areas: Investigational Device Exemption (21CFR 812); Protection of Human Subjects (i.e., informed consent) (21CFR 50); Institutional Review Boards or IRB (21CFR 56); Clinical Investigators' Financial Disclosure (21CFR 54); Good Laboratory Practice or GLP for Nonclinical Laboratory Studies (21 CFR 58); and Design Controls of the Quality System Regulation (21CFR 820).
Prerequisites
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
For example, the FDA requires that data from clinical investigations (conducted in or outside the United States) be from studies conducted in accordance with good clinical practice (GCP). These requirements are outlined in an FDA rule, “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices.”17 GCP includes review and approval by an independent ethics committee and informed consent from subjects.
Novel evidence on the effect of tramadol on self-paced high-intensity cycling
Published in Journal of Sports Sciences, 2021
Thomas Zandonai, Darías Holgado, Luis F. Ciria, Mikel Zabala, James Hopker, Tristán Bekinschtein, Daniel Sanabria
The study was a randomized, double-blind and placebo-controlled trial. All experimental procedures were designed to comply with the Declaration of Helsinki and Good Clinical Practice (GCP). The Spanish Agency of Medicines and Medical Devices (AEMPS) -EudraCT number 2018–000388-10-, and the Ethical Committee of Clinical Research of University of Granada approved the trial. The randomization process, the audit and verification of compliance of GCP rules, was performed by Foundation for the Biosanitary Research of Eastern Andalusia (FIBAO) in collaboration with Adknoma Health Research S.L. company. The method and planned analyses of this study were pre-registered on the Open Science Framework (25 April 2018 update 1 January 2020: https://osf.io/2f4vq/). All data were entered in a case report form and subsequently in a computerized and scripted database, stored at the Mind, Brain and Behaviour Research Center (CIMCYC, University of Granada).
Medical textiles
Published in Textile Progress, 2020
All practising clinicians in the United Kingdom require registration with a license to practise with the General Medical Council [287]. The General Medical Council have guidelines on good practice in research that discuss the framework of research, necessary ethics and inclusion of people who may be categorised as vulnerable, e.g. adults without capacity [288]. All individuals in the United Kingdom who are involved in the conduct of clinical research must be competent to perform their tasks, qualified by education, training and experience. Good Clinical Practice (GCP) training is the international ethical, scientific and practical standard under which all clinical research is supposed to be conducted. Compliance provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable [289].