洛施德GMP咨询 - MHRA BLOG 临床试验审查试验主文件.pdf

Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Inspecting clinical trials - The trial master file 检查临床试验—试验主文件 Gail Francis, 30 July 2015 — Compliance matters Gail Francis, 2015.07.30 —合规问题 The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights some of the issues which have been experienced by sponsors and inspectors attempting to manage and review the large amounts of documentation that exist in support of a trial. 试验主文件（TMF ）是对临床试验实施进行重现和评估的必要文件合集。主要记录的是试验执行和管理的过 程。在企业和检查官尝试管理和审核支持试验的大量文件时，会出现一些问题，本篇博客将主要针对这些问 题进行讨论。 What needs to be filed in the TMF? TMF 的内容 A common misunderstanding is that only those documents listed in section 8 of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) are required to be filed. This is incorrect and the documents listed in section 8 only provide half of the story, as a number of key areas are not included such as documentation associated with data management and Qualified Person (QP) certification. 一个常见的误区是：TMF 只需要包括人用药注册技术要求国际协调会议 （ICH）药品临床试验管理规范（GCP ） 第八部分中列举出的文件。但这种认识是不对的，因为第八部分所列举的文件仅是TMF 的一部分，一些关键 文件并未包含在内，如与数据管理和质量授权人认证相关的文件。 Another common area on documentation is correspondence associated with key decision making and trial conduct. We all use email as a key method of communication yet the correspondence section in the TMF is often very sparse or lacks the relevant emails. When as an inspector we say that we will raise a deficiency against a problem, it’s often the case that a number of em