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 ?
Guidelines for Principles and Essentials of Good Clinical Practices of Advanced Treatment Medicinal Products
The regulatory impact statement refers to good clinical practice guidelines, and Health Canada has introduced the ICH-GCP guidelines as a guidance document, but it is not part of a directly enforceable regulatory structure.
From this subset of studies, it is evident that the general practice among the clinical testing laboratories currently employed by pesticide manufacturers is to conduct studies in accordance with the two most commonly followed ethical guidelines for human studies by nongovernmental entities, the Declaration of Helsinki (World Medical Association 2002) and the international guidelines for good clinical practice (FDA 1997).
Covered topics include oral/maxillofacial imaging, histomorphometry, examiner calibration, good clinical practice, ridge augmentation, soft/hard tissue grafting, sinus augmentation and periodontal regeneration protocols.
The question is whether the company can find a business model which combines good clinical practice with economic viability.
The team from the Ministry of Health, Turkey inspected the facility and carried out a detailed audit of the facility for systems and processes meeting Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) requirements, before granting approval.
It recommends that every doctor should recognise that proper nutritional care is fundamental to good clinical practice.
These include the Helsinki Declaration, the International Guidelines for Biomedical Research Involving Human Subjects, and the Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products from the World Health Organization.
The study concludes that trial managers should look for the best quality sites because sites lacking standard operating procedures (SOPs) or non-compliant with good clinical practice (GCP) can lead to more trouble than necessary.
A new version of the scheme has been issued to support its integration into the good clinical practice risk-based inspection programme.
com)-- Pharma School - Zero Budget has completed two new chapters from its premier free course on Good Clinical Practice.