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...
Many CTN studies involve behavioral interventions. Behavioral studies may require essential documents different from, or in addition to, those required by GCP guidelines. These documents may include therapy manuals and materials, audio and videotapes of treatment sessions, and other documents specific to...
4.9.5 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 discontinuation of cli...
GCP是哪來的? 「優良臨床試驗規範(Good Clinical Practice, GCP)」是1996年由「國際醫藥法規協和會(International Council for Harmonisation, ICH)」所發布的,目的是提供歐盟、日本及美國一致的標準,促進這些區域的藥政主管機關相互接受臨床試驗數據,醫藥產業欲向主管機關提交之臨床試驗數據,都應遵從此規範。 ICH又是...
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…
According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site. A:CV of investigator and Clinical Trial Authorisation (CTA) B:Ethics CommitteeApproval and signed protocol
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...
根据良好临床实践(GCP)指南的定义,中心角色是 发起人 和 主要研究者 。 There are additional roles and responsibilities defined for other individuals and groups whose work is essential to the proper conduct of a clinical study. How these roles are referenced, may vary from one research network to ...
整体上这版GCP吸收借鉴了ICH E6(R2)的绝大部分内容,让中国的临床研究更加与国际接轨,也标志着临床试验法规体系建设基本结束,正式进入新时代。将是中国临床试验发展史上一个重要里程碑事件。 不过我们这版结合了很多国情因素,也引入了我们多年积...