5.5.11 The sponsor specific essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal...
1.23 Essential Documents 必需文件 Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial). 指各自和合在一起允许评价一个研究的执行情况和所得数据的质量文件(见8....
GCP guidelines list the essential documents (ICH GCP E6 Section 8) that, at a minimum, must be maintained for every clinical study. These documents are to be maintained by the site and the sponsor, and are classified according to the stage of a study at which they are normally created. T...
5.5.11 The sponsor specific essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal...
第八章、執行臨床試驗之必要文件(Essential Documents) ● 執行臨床試驗之必要文件由「臨床試驗開始前」、「臨床試驗執行期間」及「試驗完成或終止後」三個階段所組成,這些文件通常由Sponsor的獨立稽查部門稽查,並由監管機構查核,作為確認試驗有效性和收集資料完整性過程的一部分。
In addition to the essential documents included in the GCP guideline, the sponsor may require other documentation. The following lists examples of other documentation that may apply to clinical trials. 除GCP指南中包含的基本文件外,申办方可能需要其他文件。以下列出了可能适用于临床试验的其他文件的示例。
试题来源美国Pharma School Online Learning,如果对答案有异议,欢迎后台留言相互探讨。 QuestionNumber: 1 of 10 According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site.
试题来源美国Pharma School Online Learning,如果对答案有异议,欢迎留言相互探讨。 ★ QuestionNumber: 1 of 10 According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site.
1.23EssentialDocuments 必需文件 Documentswhichindividuallyandcollectivelypermitevaluationoftheconductofastudyandthequalityofthedatapro duced(see8.EssentialDocumentsfortheConductofaClinicalTrial). 指各自和合在一起允许评价一个研究的执行情况和所得数据的质量文件(见 8.实施临床试验的必需文 件)。 1.24GoodClinical...
5.5.6The sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents pertaining to the trial (see 8. Essential Documents for the Conduct of a Clinical Trial). 申办者或数据得其他拥有者应当保留申办者当得有关试验得所...