good clinical practice


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good clinical practice

A term of art used in clinical trials for the 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 and confidentiality of trial subjects are protected.
References in periodicals archive ?
The term "good clinical practice" (GCP) has been defined in relation to clinical trial conduct.5,6 GCP is defined by European Medical Authority as "an international ethical and scientific quality standard for designing, conducting recording and reporting trials that involve the participation of human subjects, compliance with this standard provides public assurance that the rights, safety and well-being of trial subject are protected, consistent with principal that their origin in the Declaration of Helsinki, and the clinical trial data are credible."5
Compliance with good clinical practice and ethical considerations: From the study subjects' perspective, this element of protocol deserves lots of attention.
ICH Topic E6: good clinical practice. London: European Agency for the Evaluation of Medicinal Products; 1996 Jul.
Although global trials entail a benefit to the participating countries, to their populations and to public health, they raise a new challenge for checking whether the trials comply with good clinical practice requirements.
Guidance for Conduction of Good Clinical Practice Inspections of Sponsor and Contract Research Organization
They are well suited to present the informed consent prior to treatment, and can interpret and translate the protocol for the patient, once trained in the principles of good clinical practice. Good clinical practice "is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects." (6) Some of the common strengths of PRCs include organizational expertise, communication skills and attention to detail.
"Our one of the biggest aims is to make PIMA a source of continuing learning for doctors' community, to develop physicians with GCP (Good Clinical Practice).
(15.) The SA Good Clinical Practice (2006) guidelines require researchers and sponsors to take out comprehensive insurance for research-related injury.
An official of MOEA says Taiwan aims to increase new industrial cooperation with a focus on biotechnological industry, including adopting international standards of GLP (good laboratory practice), GMP (good manufacturing practice), and GCP (good clinical practice) etc.
The Scottish Government said the drugs were "effective evidence-based treatments for mental illness" and were prescribed "in line with good clinical practice".
A trust spokesman said: "The review in March 2009, while broadly noting the good clinical practice and reputation of the unit, did highlight concerns over the recording and use of paid overtime.
Clinical Trials Partnership Middle East Summit kicks off with an interactive workshop on day one, looking at a comprehensive overview of 'Good Clinical Practice' in relation to the regional and international guidelines for conducting clinical trials.