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Managing clinical investigator compliance to ensure Food and Drug Administration (FDA) inspection readiness.

机译：管理临床研究人员的依从性，以确保食品药品监督管理局（FDA）的检查准备就绪。

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摘要

I conducted my clinical research and management internship at the Dallas headquarters of MedTrials, a full-service contract research organization (CRO). As a full-service CRO, MedTrials offers professional services including clinical trial management, monitoring, auditing, training, data management, statistical analysis and reporting in all phases and types of clinical trials. MedTrials is dedicated to provide high quality customized solutions to clients throughout the pharmaceutical, medical device and biologics industries.;For my practicum report, I focused on 'Managing Clinical Investigator Compliance to Ensure Food and Drug Administration (FDA) Inspection Readiness'. Compliance in clinical trials is adherence to the federal and other applicable regulations. In the U.S. The FDA is responsible for protecting the subject safety in clinical trials involving drugs, biologics, devices, veterinary products and food products. The FDA conducts inspections of the sites conducting clinical trials to check for the site compliance. These inspections are conducted by a program called Bioresearch Monitoring (BIMO). BIMO is responsible for on-site inspections and data audits. The goal of the BIMO program is assuring quality and integrity of FDA regulated research data submitted to the agency in support of new products approval applications and also to ensure protection of rights and welfare of thousands of human subjects participating in clinical trials under the applicable regulations.;Knowledge of common causes leading to non-compliance findings during inspections by the FDA is useful in preventing future non-compliance issues at the sites and thereby, official actions by FDA. Specific aims of this internship project were designed for obtaining knowledge on the compliance issues focused by the BIMO inspectors. Specific aim 1 focused on statistical data of BIMO inspections on clinical investigators and sponsors/monitors. For this the BIMO accomplishments updates published on the FDA website were reviewed. The second specific aim was designed to obtain three most common non-compliance issues at the clinical sites. For discovering the common non-compliance issues, FDA warning letters were reviewed and an electronic survey was conducted. The results indicated the most common non-compliance issues focused by the BIMO inspectors and monitors responsible for checking the compliance differ from each other. The third specific aim was intended to develop a tool that can be used by sponsors/CRO for assessing site compliance during the study and to prepare recommendations for preventing the common compliance issues at the sites. For developing the tool for assessing site compliance, FDA warning letters were reviewed and compliance areas focused in them were noted and a checklist was prepared. This checklist could be used by monitors during their site monitoring visits. The recommendations could help the sponsor in preventing common non-compliance issues at their sites thus pro-actively preventing official actions by FDA inspectors.;Along with working on my practicum report, I assisted both the clinical and quality assurance departments of MedTrials. I worked in the role of compliance specialist and assisted both the departments in ensuring internal and site compliance of various studies.
机译：我在提供全方位服务的合同研究组织（CRO）MedTrials的达拉斯总部进行了临床研究和管理实习。作为全方位服务的CRO，MedTrials提供专业服务，包括临床试验的所有阶段和类型的临床试验管理，监测，审计，培训，数据管理，统计分析和报告。 MedTrials致力于为整个制药，医疗器械和生物制药行业的客户提供高质量的定制解决方案。在我的实习报告中，我专注于“管理临床研究人员的依从性，以确保食品药品管理局（FDA）的检查准备就绪”。临床试验的依从性符合联邦法规和其他适用法规。在美国，FDA负责在涉及药物，生物制剂，设备，兽药和食品的临床试验中保护受试者的安全。 FDA对进行临床试验的场所进行检查，以检查场所的依从性。这些检查由称为生物研究监测（BIMO）的程序进行。 BIMO负责现场检查和数据审核。 BIMO计划的目标是确保提交给该机构的FDA监管研究数据的质量和完整性，以支持新产品批准申请，并确保根据适用法规保护数千名参加临床试验的人类受试者的权利和福祉。 ；了解导致FDA检查期间发现不合规问题的常见原因，有助于防止将来在现场发生不合规问题，从而防止FDA采取正式行动。该实习项目的具体目标旨在获取BIMO检查员关注的合规性问题知识。具体目标1集中于BIMO对临床研究者和申办者/监测者的检查的统计数据。为此，对FDA网站上发布的BIMO成就更新进行了审查。第二个特定目标旨在在临床部位获得三个最常见的不合规问题。为了发现常见的不合规问题，审查了FDA警告信并进行了电子调查。结果表明，BIMO检查员和负责检查合规性的监控人员关注的最常见的不合规问题彼此不同。第三个具体目标是要开发一种工具，供发起人/ CRO在研究过程中用来评估站点的合规性，并为防止站点中常见的合规性问题提供建议。为了开发评估站点合规性的工具，审查了FDA警告信，并记录了针对这些警告的合规领域，并准备了清单。监视器可以在其站点监视访问期间使用此清单。这些建议可以帮助申办者预防其站点上常见的不合规问题，从而积极防止FDA检查员采取正式行动。;在撰写实践报告的同时，我还协助了MedTrials的临床和质量保证部门。我担任合规专家一职，并协助两个部门确保各种研究的内部和现场合规性。

著录项

  • 作者

    Yadlapalli, Sowmya.;

  • 作者单位

    University of North Texas Health Science Center at Fort Worth.;

  • 授予单位 University of North Texas Health Science Center at Fort Worth.;
  • 学科 Health Sciences Health Care Management.
  • 学位 M.S.
  • 年度 2011
  • 页码 80 p.
  • 总页数 80
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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