File notes and breach reports: when are they appropriate?
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چکیده
منابع مشابه
File notes and breach reports: when are they appropriate?
Protocol and/or GCP deviations occur in many clinical trials. There are clear definitions and reporting guidelines on serious breaches in Clinical Trials of Investigational Medicinal Products (CTIMPs)[1]. However there is no such national guidance for non-CTIMPs. For any trial design, there is little, if any, information on when and for what type of incident it is appropriate to write a file no...
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ژورنال
عنوان ژورنال: Trials
سال: 2013
ISSN: 1745-6215
DOI: 10.1186/1745-6215-14-s1-p133