Search results
Results From The WOW.Com Content Network
Good clinical practice. In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...
The Instituto Questão de Ciência (IQC) (English: Science Question Institute) is a Brazilian non-profit organisation founded in 2018, dedicated to the promotion of scientific and critical thinking and the use of scientific evidence in public policies. [2][3][4][5][6][7]
National Institute for Health and Care Excellence. The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body, in England, of the Department of Health and Social Care, [1] that publishes guidelines in four areas: guidance for social care services and users. These appraisals are based primarily on ...
Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies. Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested ...
A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...
The PRISMA flow diagram, depicting the flow of information through the different phases of a systematic review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care ...
The STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement is a reporting guideline including a checklist of 22 items that are considered essential for good reporting of observational studies. It was published simultaneously in several leading biomedical journals in October and November 2007 and comprises both ...
NGC Guideline Syntheses often provide a comparison of guidelines developed in different countries, providing insight into commonalities and differences in international health practices. An electronic forum, NGC-L for exchanging information on clinical practice guidelines, their development, implementation and use