首页 > 资讯 > FDA发布两则临床试验指南草案

出自识林

2012-12-01 FDA

FDA发布两则临床试验指南草案 新发布指南草案涉及临床研究中电子源数据（Electronic Source Data in Clinical Investigations）和机构审查委员会关于申办方资质确认，评估临床实验基地是否适当、以及判断研究用新药（IND）申请和器械临床研究豁免（IDE）申请必要性等方面的职责。

Electronic Source Data in Clinical Investigations - Draft Guidance for Industry

In an effort to streamline and modernize clinical investigations, this guidance provides recommendations to sponsors, Contract Research Organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors
FDA is issuing this guidance to remind institutional review boards (IRBs) of their longstanding role in the review of 1) the qualifications of the clinical investigator, 2) the adequacy of the facility in which the research will take place, and 3) the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) application is necessary for the proposed clinical investigation. Electronic Source Data in Clinical Investigations - Draft Guidance for Industry