FDA和OHRP指导

食品和药物管理局（FDA）指南

食品药品监督管理局（FDA）发布了许多有用的指导文件，这代表了该机构对特定主题的当前解释。以下中心列出了指向指南文件的链接：



人类研究保护办公室（OHRP）指南

OHRP的网站提供了多个指导文档，代表了他们当前对主题的想法。这些文件应视为建议。


OHRP网站还提供了一个“常见问题”部分，可作为IRB，赞助商和调查人员的良好参考。


FDA和OHRP合规性发现

OHRP:OHRP网站上概述了过去几年中合规监督确定信中指出的重大发现和问题：


FDA:Each year the FDA posts the prior year's most common observations from bioresearch monitoring. FY 2015 findings can be found这里。


这些选定的确定信中强调了临床研究人员，机构审查委员会和赞助商的常规FDA审核期间所指出的常见不合规问题的示例。值得注意的是，这些信件还解决了FDA是否可以接受提出的纠正措施。



临床研究者的例子

示例1

  • 未根据签署协议，调查计划，适用的FDA法规以及机构审查委员会（IRB）或FDA施加的任何批准条件进行调查。
  • Failure to maintain accurate, complete, and current records of disposition of a device.
  • 示例1

示例2

  • Failure to obtain Institutional Review Board (IRB) approval for changes in the research prior to implementing the changes
  • 示例2

示例3

  • Failure to ensure that the investigation was conducted according to the investigational plan
  • 示例3

示例4

  • Failure to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and the applicable regulations, and to protect the rights, safety, and welfare of subjects under your care
  • Failure to administer the drug only to subjects under the investigator’s personal supervision or under the supervision of a subinvestigator responsible to the investigator
  • Failure to prepare and maintain adequate and accurate case histories that recorded all observations and other data pertinent to the investigation on each individual administered the investigational drug. Case histories include case report forms and supporting data
  • Failure to obtain the informed consent of each human subject to whom the drug was administered in accordance with the provisions of 21 CFR Part 50.
  • 示例4

示例5

  • Failure to personally conduct or supervise the clinical investigations
  • 无法确保符合第56部分中规定的要求的IRB是对拟议临床研究的初步和持续审查和批准的原因
  • 示例5

示例6

  • 未能维持适当的药物处置记录，包括日期，数量和受试者使用
  • Failure to promptly report to the IRB all unanticipated problems involving risk to human subjects or others
  • 示例6


Sponsor Examples

示例7

  • 不包括所有适当的知情同意元素。
  • 未能为调查人员提供正确进行调查所需的信息，并且未能确保对调查进行正确监控
  • 未能获得签署的调查员协议和足够准确的财务披露信息。
  • Failure to maintain accurate, complete, and current device shipment and disposition records.
  • 示例7

示例8

  • Failure to obtain Institutional Review Board approval of the investigation
  • 未能根据第812.140（b）（4）条维护所需的记录，并制作第812.150（b）（1）（1）到（3）和（3）和（5）至（10）至（10）至（21 CFR 812.2（b）（1）条规定的报告（v]
  • 示例8

示例9

  • Failure to ensure proper monitoring of the investigations and failure to ensure that the investigations are conducted in accordance with the general investigational plan and protocols contained in the IND
  • 未能从研究人员那里获得足够的财务信息，以允许赞助商提交21 CFR第54部分要求的完整，准确的认证或披露声明
  • 未能正确记录知情同意书，无法保持准确，完整和当前的记录，并根据适用的FDA法规进行调查，以保护调查人员护理下的受试者权利，安全和福利。
  • Failure to maintain accurate, complete, and current records of each subject’s case history and exposure to the device.
  • 示例9


IRB例子

示例10

  • Failure to fulfill membership requirements
  • Failure to review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas
  • 未能准备和维护足够的IRB活动文件
  • 示例10

示例11

  • Failure to prepare, maintain, and follow required written procedures governing the functions and operations of the IRB
  • Failure to notify investigators and the institution in writing of its decision to approve or disapprove proposed research activities or of modifications required to secure IRB approval of the research activity
  • 未能确保知情同意的基本要素包括在IRB批准的同意书中
  • 示例11

示例12
  • 未能准备，维护和遵循书面程序，以进行最初和持续的研究审查
  • Failure to review proposed research at convened meetings at which a majority of the members of the IRB are present
  • Failure to report promptly to the FDA any suspension or termination of approval and failure to prepare written procedures
  • Failure to prepare and maintain a list of IRB members identified by name, earned degree, representative capacity, and the relationship between each member and the institution
  • 示例12

示例13

  • 完成研究完成后，未能将IRB记录保留至少3年。
  • 未能准备和维护足够的IRB活动文件including minutes of IRB meetings that are of sufficient detail to show the actions taken at the meeting and the vote on these actions
  • 示例13

示例14

  • 在初次审查时未能确定涉及儿童的研究符合21 CFR第50部分，D子部分，儿童的其他保障措施
  • 未能确保没有成员参与对成员具有冲突的项目的初始或继续审查，但提供IRB要求的信息除外
  • Failure to conduct continuing review of research at intervals of not less than once per year
  • 示例14