Registration audit of clinical trials given a favourable opinion by UK research ethics committees
نویسندگان
چکیده
منابع مشابه
Research ethics committee audit: differences between committees.
The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated he...
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OBJECTIVES To assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees. DESIGN Review of original research protocols. STUDY SELECTION Unpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicina...
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Each of the following papers gives an account of a different UK clinical ethics committee. The committees vary in the length of time they have been established, and also in the main focus of their work. The accounts discuss the development of the committees and some of the ethical problems that have been brought to them. The issues raised will be relevant for other National Health Service (NHS)...
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ژورنال
عنوان ژورنال: BMJ Open
سال: 2019
ISSN: 2044-6055,2044-6055
DOI: 10.1136/bmjopen-2018-026840