Clinical trials for medicines: Good clinical practice inspections
正文 · 中文译文
指南 药品临床试验：药物临床试验质量管理规范检查 与药物临床试验质量管理规范（GCP）检查相关的信息。 发布机构： 英国药品和健康产品管理局 发布日期： 2014年12月18日 最后更新日期： 2026年11月6日 — 查看所有更新 订阅此页面的电子邮件通知 打印此页面 目录 GCP合规性 基于风险合规计划下的检查 触发式检查 检查前文件 试验主文件（TMF） 检查计划 检查期间 检查发现 检查发现的分级 检查报告 检查后的措施 GCP检查费用 GCP检查指标 违规通知 违规函 临床试验的监督与监测 申办方代表在临床试验中对电子健康记录的现场访问 立场声明 联系方式 人用药品技术要求国际协调理事会（ICH）已制定药物临床试验质量管理规范指南（ICH E6（R3））。 药物临床试验质量管理规范（GCP）是一项关于药品临床试验设计、实施、分析和报告的伦理与科学质量标准。 ICH E6（R3）药物临床试验质量管理规范由总体原则、附录1（干预性临床试验）、附录2（非传统干预性临床试验的附加考虑）、术语表和附录组成。 关于在英国实施 ICH E6（R3）GCP 的更多信息，请参见英国遵守 ICH E6 药物临床试验质量管理规范（GCP）指南；关于 ICH E6（R3）的英国特定注释，请参见 ICH E6（R3）英国特定注释。 根据上述 MHRA 指南必须遵守 GCP 的组织包括： 制药公司 为申办者和研究者开展临床试验的任何职能提供服务的组织（例如合同研究组织、开发和维护试验特定计算机化系统的组织） 大学 NHS 医院 慈善机构 全科医生诊所 分析来源于临床试验样本的实验室（包括 NHS、学术和商业实验室） 为支持 GCP 合规，MHRA： 要求申办临床试验的组织向其报告严重违背 在怀疑存在严重违背时，可对组织进行触发式检查 可对申办或开展临床试验的组织进行基于风险的常规检查 可对为支持上市许可申请而提交的临床试验及相关活动进行检查 遵守 GCP 您必须向我们报告严重违背 GCP 或试验方案的情况。参见《严重违背 GCP 或试验方案报告指南》。 参见 MHRA GCP 转介年度汇总。 基于风险合规计划下的检查 大多数MHRA GCP检查是在基于风险的合规计划下进行的。这些检查可以是基于系统的，也可以是特定试验的。 GCP系统检查审查一个组织开展临床试验研究所使用的系统。检查员将选择若干临床试验，以审查该组织的试验程序如何得到应用。还可能对参与所选试验的1或2个研究者中心进行检查。 特定试验的GCP检查评估单项临床试验，参与该试验的任何组织都可能被检查。这些检查可以是基于风险的常规检查，也可以涉及作为上市许可申请一部分提交的某项试验。 此外，属于I期认证计划的I期病房会定期接受检查，以评估其是否符合该计划的要求。还可能进行检查以评估试验实施情况以及对GCP和监管要求的符合性。 基于风险的检查计划利用MHRA可获得的信息来确定一个组织的风险。这些信息包括： 内部信息，包括临床试验申请、上市许可申请、以往的合规和检查历史 组织变更 来自外部来源的情报 常规GCP检查按下图进行，下文各节对每个步骤提供了更多细节。该图展示了检查计划、实施和报告的典型步骤，尽管顺序可能有所不同。 计划 ⮕ 检查 ⮕ 报告与结案 已发出法定检查事先通知 主机构检查 已发出检查报告 已提交GCP档案 视需要检查其他场所 机构对报告作出回应 已确认检查日期 关键问题的升级路径 已审查回应及相关措施 已索取检查前文件 CMT与IAG2 合规管理团队与检查行动组 检查结案并发出声明 已提供检查前文件 已商定检查计划 触发性检查 如果我们怀疑存在违法行为，可能会联系某机构以安排检查。该信息可能来自： 严重违规通知 举报人 MHRA其他部门 其他监管情报 健康研究管理局（HRA） 在少数情况下，我们可能几乎不提前通知或不提前通知即开展这些检查。 检查前文件 如果您的机构正被考虑接受检查，我们将通知您，除非该检查将在不提前通知的情况下进行。 通知将包括要求以GCP检查档案和临床试验电子表格形式提供信息，且必须在30天内提供。 我们将使用所提供的信息评估您机构的临床试验活动，确定是否需要检查，并在适当情况下确定需审查的领域并界定检查范围。 如果要求您提供档案，您应使用以下模板。 标准GCP档案： GCP检查档案模板（MS Word文档，153 KB） GCP检查档案临床试验电子表格（MS Excel电子表格，35 KB） GCP检查档案核对表（MS Word文档，181 KB），以确保您的档案完整。 计算机化系统档案： GCP检查档案模板——计算机化系统（MS Word文档，93.8 KB） GCP检查档案临床试验电子表格——计算机化系统（MS Excel电子表格，158 KB） GCP检查档案核对表——计算机化系统（MS Word文档，105 KB） 在对档案进行审查后，将商定检查日期，您将收到检查组成员详情以及与检查相关的实用信息。档案中提供的信息将用于确定检查期间需审查的领域，并帮助界定检查的范围和重点。我们将力求商定一个双方都方便的日期；但若无法达成一致，情况可能需要我们自行设定检查日期。 在某些情况下，档案审查可能表明无需进行检查，主检查员可决定不再进一步推进。 试验主文件（TMF） 通常会选择若干临床试验进行试验主文件（TMF）审查，但检查可能不限于这些试验。 完整的试验主文件（TMF）是检查的基础，其中的所有记录都必须提供给检查员。这包括任何电子记录和电子邮件。您需要提供访问任何电子记录所需的设备和软件。当多个电子系统构成完整的TMF时，必须提供对每个系统的直接访问权限。 您可以事先与主检查员讨论如何在检查期间提供TMF。 如果您是申办者并将部分活动分包给服务提供商，则该组织需要提供对TMF和/或其他记录的访问权限。 如果您在满足这些要求方面存在困难，应在检查前告知主检查员。 未能提供TMF将影响您的检查结果。 检查计划 检查计划基于与您的讨论以及您在GCP检查档案中提供的信息，以确保涵盖所有活动。应有合适的人员接受面谈或通过电话会议接受面谈。 可能需要额外的支持性文件，如行列表、数据库摘录和平面图。您应在与主检查员商定的时间内提供所有要求的文件。 检查员将灵活调整检查计划，以适应个人的工作模式和出现的紧急问题。 除非是简短通知检查或无通知检查，否则您将在检查前收到检查计划。您可以与主检查员讨论任何与该检查相关的意见或问题。 检查期间 检查包括访谈相关人员以及对文件（如试验主文件（TMF））的审查。您应准备好应检查员要求提供补充文件。在现场检查期间，检查员可能会走访任何相关部门。 检查发现 检查结束时，检查员将向您口头总结检查发现，并给您机会纠正任何误解。检查发现的评级是暂定的，检查员在编写报告时可能会更改。 检查发现的评级 检查期间发现的缺陷分为3个等级：严重、主要和其他。 严重 a) 存在证据表明发生了对适用法规要求的重大且无正当理由的偏离，并有证据表明： 受试者的权利、安全或福祉已经或极有可能受到危害，和/或 临床试验数据不可靠，和/或 在各责任领域存在若干主要不符合项（定义见(d)和(e)），表明存在系统性质量保证失效，和/或 b) 对先前报告的主要不符合项（定义见(d)和(e)）采取了不适当、不充分或不及时的纠正措施。 c) 试验主文件（TMF）的提供不符合第31A条第1-3款的规定，因为TMF不能随时获得或访问，或者TMF不完整的程度使其无法构成检查的基础，从而妨碍或阻碍检查人员履行核实法规遵守情况的职责。 重大 d) 存在证据表明发生了对适用法律要求的重大且不合理的偏离，该偏离可能尚未发展为关键问题，但除非加以处理，否则有可能发展为关键问题的非关键发现，和/或 e) 存在证据表明在单一责任领域内发生了多项对适用法律要求和/或既定药物临床试验质量管理规范（GCP）指南的偏离，表明存在系统性质量保证失效。 其他 f) 存在证据表明发生了对适用法律要求和/或既定GCP指南和/或程序要求和/或良好临床实践的偏离，但该偏离既非关键也非重大。 检查报告 检查报告通过电子邮件发送给机构检查接待人。您必须对该报告作出回应。您的机构必须以纠正措施和预防措施（CAPA）计划的形式对检查报告作出回应，参见CAPA指南以了解如何制定对GCP检查发现的回应（MS Word文档，75.8 KB）。针对检查发现，机构可能被要求完成影响评估，相关要求的详细信息将包含在报告中。对于某些检查，您可能需要定期报告拟议CAPA措施的进展情况。 首席检查员可能会要求您对所提供回应中的内容作进一步澄清。通常，您将有一次机会提供补充信息或澄清。 一旦收到充分的回应，您将通过电子邮件收到GCP检查声明。 检查后的措施 如果发现关键缺陷，这些缺陷将被提交至GCP检查行动组（IAG2）。这是一个跨机构小组，负责监督所有关键缺陷，并决定除审查关键缺陷的CAPA之外还需采取的措施。 根据关键缺陷及其对公共安全和数据完整性的影响，IAG可能考虑采取若干可能的非例行检查后措施。这些措施包括： 定期报告 提前重新检查 转介给相关利益相关方（例如，其他监管机构/机构、健康研究管理局（HRA）、综合医学委员会（GMC）、护理质量委员会（CQC）） 暂停CTA 侵权通知 起诉 GCP检查费用 检查费用 向MHRA付款 GCP检查指标 为帮助您了解GCP检查员在英国GCP检查期间发现合规问题的领域，GCP检查部门编制了指标报告。 侵权通知 当发现严重或严重且持续不遵守GCP要求的情况时，可发出侵权通知。 以下是已针对GCP发出的所有侵权通知。部分信息可能被涂黑。被涂黑的信息包含个人数据要素，披露这些信息将不公平，因为这会违反《数据保护法》的第一项原则，该原则规定信息必须被公平合法地处理 组织/个人 发布日期 原因 状态 Celixir 2024年7月17日 监管行动 Celixir认可了MHRA检查的发现，并提出了一套纠正和预防措施（CAPAs），该措施全面且包含有效措施，以确保符合GCP和试验授权，以及通知中所述的研究用药品档案（IMPD）的符合性，并确保Celixir未来参与的临床试验活动完全符合法规要求。在此过程中，Celixir向MHRA提供了所有信息，且不持有任何可识别接受（安慰剂）给药患者的信息。CAPAs的实施和GCP的合规性已由一名专业的GCP审计员独立审计并确认，该审计员受聘以确保Celixir持续符合GCP、试验授权以及IMPD的符合性。 David Connell博士 2016年3月14日 监管行动 Connell博士对违规通知作出回应，确认他已放弃在英国行医的执照，且无意再次在英国行医。Connell博士已确认，如果他将来确实在英国参与临床试验，他将遵守违规通知的条件。Connell博士还确认，他未保留涉事试验的任何数据或文件，因此MHRA也希望强调，在没有任何保留数据的情况下，无法验证该临床试验所发表的结论。 Zirka Yousaf夫人 2016年7月1日 监管行动 Zirka Yousaf女士对违规通知作出回应，确认她已实施标准操作规程（SOP）和检查清单，以确保未来工作得到充分记录，将确保未来工作承诺切实可行，并且不会将工作外包或分包给另一承包商。Zirka Yousaf女士已确认她将遵守违规通知的条件。MHRA已核实对患者安全没有影响。然而，MHRA还想提醒申办者，他们对药物临床试验质量管理规范（GCP）负有最终责任。因此，申办者有责任确保对其试验中所有工作人员进行监督，包括承包商和可能居家办公的人员。适当完善的合同和充分的监督机制可以发现并因此降低本违规通知中所观察到的不合规情况发生的可能性。 Jerome Kerrane博士 2017年11月9日 监管措施 Kerrane博士对违规通知作出回应，确认他已接受与GCP、信息治理和财务诚信相关的进一步培训。Kerrane博士已确认自2015年以来未参与临床试验活动，且未来无意开展试验工作。MHRA想提醒研究者有义务遵守经批准的试验方案，以确保试验参与者的安全和所收集数据的完整性；并提醒试验申办者有必要进行有效监查。 RC ALS / Michael Richard Curran 2026年7月21日 监管措施 MHRA 就涉及 Neuralzeta/RCH4 的一项未经授权临床试验的实施发出了违规通知。该试验在未取得所需监管授权或伦理委员会赞成意见的情况下即已启动，且未按照 GCP 开展。该通知要求立即停止供应 Neuralzeta/RCH4 以及与该项未经授权试验相关的所有活动。未来在英国开展的任何临床试验活动都必须遵守适用的监管要求和 GCP 要求。 违规函件 Celixir 违规通知（PDF，112 KB，3 页） Zirka Yousaf 女士违规通知（PDF，3.97 MB，11 页） David Connell 医生违规通知（PDF，786 KB，2 页） Jerome Kerrane 医生违
正文 · 英文原文
Guidance Clinical trials for medicines: Good clinical practice inspections Information relating to good clinical practice (GCP) inspections. From: Medicines and Healthcare products Regulatory Agency Published: 18 December 2014 Last updated: 6 November 2026 — See all updates Get emails about this page Print this page Contents Compliance with GCP Inspections under the risk-based compliance programme Triggered inspections Pre-inspection documentation The trial master file (TMF) The inspection plan During the inspection Inspection findings Grading of inspections findings The inspection report Actions after the inspection Fees for GCP inspections GCP inspection metrics Infringement notices Infringement letters Oversight and monitoring of clinical trials On-site access to electronic health records by sponsor representatives in clinical trials Position statements Contact The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has produced guidance on Good Clinical Practice (ICH E6 (R3). Good clinical practice (GCP) is an ethical and scientific quality guideline concerning the design, conduct, analysis and reporting of clinical trials of medicines. ICH E6 (R3) Good Clinical practice is composed of overarching principles, Annex 1 (interventional clinical trials), Annex 2 (additional considerations for non-traditional interventional clinical trials), Glossary and Appendices. For more information on implementation of ICH E6 (R3) GCP in the UK see guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom and for UK specific annotations to ICH E6 (R3) see UK-specific annotations to ICH E6(R3) . Organisations that have to comply with GCP as set out in the MHRA guidance above include: pharmaceutical companies organisations who provide services to undertake any function of the sponsor and investigator conducting clinical trials (e.g. contract research organisations, organisations who develop and maintain trial specific computerised systems) universities NHS hospitals charities GP practices laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories) To support compliance with GCP, the MHRA: requires organisations sponsoring clinical trials to notify them of serious breaches may conduct triggered inspections of organisations where serious breaches are suspected may conduct routine risk-based inspections of organisations that sponsor or conduct clinical trials may conduct inspections of clinical trials, and associated activities, submitted in support of a marketing authorisation application Compliance with GCP You must notify us of serious breaches of GCP or the trial protocol. See Guidance for the notification of serious breaches of GCP or the trial protocol . See the annual summary of MHRA GCP referrals. Inspections under the risk-based compliance programme The majority of MHRA GCP inspections are carried out under the risk-based compliance programme. These can be either systems-based or trial specific. GCP systems inspections examine the systems used by an organisation to conduct clinical trial research. The inspectors will select a number of clinical trials to examine how the organisation’s trial procedures are applied. 1 or 2 investigator sites involved in the selected trials may also be inspected. Trial-specific GCP inspections assess an individual clinical trial and any organisation involved in the trial may take place. These may be risk-based routine inspections or concern a trial that has been submitted as part of an application for a marketing authorisation. Additionally, phase I units that are part of the phase I accreditation scheme are regularly inspected to assess compliance with the requirements of the scheme. Inspections may also be conducted to assess trial conduct and compliance with GCP and regulatory requirements. The risk-based inspection programme uses information available to the MHRA to determine an organisation’s risk. This information includes: internal information including, clinical trial applications, marketing authorisation applications, previous compliance and inspection history organisational changes intelligence from external sources Routine GCP inspections are conducted as per the diagram below, and more detail is provided in the sections below for each step. This figure shows the typical steps for planning, conducting, and reporting an inspection, though the order may vary. Planning ⮕ Inspection ⮕ Reporting & closure Advance notice of statutory inspection issued Main organisation inspection Inspection report issued GCP dossier submitted Other sites inspected as needed Organisation response to report Inspection dates confirmed Escalation route for critical issues Response and associated actions reviewed Pre-inspection documents requested CMT & IAG2 Compliance Management Team & Inspection Action Group Inspection closed and statement issued Pre-inspection documents supplied Inspection plan agreed Triggered inspections An organisation may be contacted to arrange an inspection if we suspect the law has been broken. This information might come from: a serious breach notification a whistleblower other MHRA departments other regulatory intelligence the health research authority (HRA) In rare circumstances, we may give little or no notice of these inspections. Pre-inspection documentation We will notify you if your organisation is being considered for inspection, unless the inspection is to be conducted without notice. The notification will include a request for information in the form of a GCP inspection dossier and a clinical trials spreadsheet, which must be provided within 30 days. We will use the information provided to assess your organisation’s clinical trial activities, determine whether an inspection is required and, where appropriate, identify the areas to be examined and define the scope of the inspection. If you are asked to provide a dossier, you should use the following templates. Standard GCP dossier: GCP inspection dossier template (MS Word Document, 153 KB) GCP inspection dossier clinical trial spreadsheet (MS Excel Spreadsheet, 35 KB) GCP inspection dossier checklist (MS Word Document, 181 KB) to ensure your dossier is complete. Computerised Systems dossier: GCP inspection dossier template - Computerised Systems (MS Word Document, 93.8 KB) GCP inspection dossier clinical trial spreadsheet - Computerised Systems (MS Excel Spreadsheet, 158 KB) GCP inspection dossier checklist - Computerised Systems (MS Word Document, 105 KB) Following review of the dossier, an inspection date will be agreed and you will receive details of the inspection team and practical information relating to the inspection. The information provided within the dossier will be used to determine the areas to be examined during the inspection and to help define its scope and focus. We will seek to agree a mutually convenient date; however, circumstances may require us to set the inspection date if agreement cannot be reached. In some cases, review of the dossier may indicate that an inspection is not required, and the lead inspector may decide not to proceed further. The trial master file (TMF) A number of clinical trials are usually selected for trial master file (TMF) review, although the inspection may not be limited to these. The complete TMF is the basis for inspection and all the records in it must be made available to the inspectors. This includes any electronic records and emails. You’ll need to provide any equipment and software needed to access any electronic records. Where multiple electronic systems constitute the complete TMF direct access must be made available to each system. You can discuss with the lead inspector beforehand on how to make the TMF available during the inspection. If you are a sponsor and have subcontracted some activities to a service provider, then the organisation will need to provide access to the TMF and/or other records. If you have problems meeting these requirements, you should tell the lead inspector before the inspection. Failure to provide the TMF will affect the results of your inspection. The inspection plan The inspection plan is based on discussions with you and the information provided in your GCP inspection dossier, to ensure all activities are covered. Appropriate people should be available for interview either in person or by teleconference. Additional supporting documentation such as line listings, database extracts and floor plans. might be needed. You should provide all documentation requested within the time agreed with the lead inspector. Inspectors will be flexible with the inspection plan to accommodate working patterns of individuals and immediate issues if they arise. You will receive an inspection plan in advance of the inspection unless it is a short or no notice inspection. You can discuss any comments or questions relating to with the lead inspector. During the inspection The inspection includes interviews with relevant people and a review of the documentation, such as the TMF. You should be prepared to provide additional documentation to the inspectors on request. The inspector may visit any relevant departments during an on-site inspection. Inspection findings At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings. The grading of the findings are provisional and may be changed by the inspector when compiling the report. Grading of inspections findings Deficiencies found during inspections are graded at 3 levels: critical, major and other. Critical a) Where evidence exists that significant and unjustified departure(s) from applicable legislative requirements has occurred with evidence that: the rights, safety or well-being of trial subjects either has been or has significant potential to be jeopardised, and/or the clinical trial data are unreliable and/or there are a number of Major non-compliances (defined in (d) and (e)) across areas of responsibility, indicating a systematic quality assurance failure, and/or b) Where inappropriate, insufficient or untimely corrective action has taken place regarding previously reported major non-compliances (defined in (d) and (e)). c) Where provision of the TMF does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations. Major d) A non-critical finding where evidence exists that a significant and unjustified departure from applicable legislative requirements has occurred that may not have developed into a critical issue, but may have the potential to do so unless addressed, and/or e) Where evidence exists that a number of departures from applicable legislative requirements and/or established GCP guidelines have occurred within a single area of responsibility, indicating a systematic quality assurance failure. Other f) Where evidence exists that a departure from applicable legislative requirements and/or established GCP guidelines and/or procedural requirement and/or good clinical practice has occurred, but it is neither critical nor major. The inspection report The inspection report is emailed to the organisation inspection host. You must respond to the report. Your organisation must provide a response to the inspection report in the form of a corrective action and preventative action (CAPA) plan, see CAPA guidance for formulating responses to GCP inspection findings (MS Word Document, 75.8 KB). In response to inspection finding the organisation may be required to complete an impact assessment, details of any requirement in this regard will be included in the report. For some inspections, you may need to provide periodic reports on the progress of proposed CAPA actions. The lead inspector may ask you for additional clarification from the responses you provided. Usually, you will be given one opportunity to provide additional information or clarification. Once adequate responses are received, you will receive a GCP inspection statement by email. Actions after the inspection If critical findings are identified, these are referred to the GCP Inspection Action Group (IAG2). This is a cross-agency group that oversees all critical findings and decides on the actions to be taken in addition to the review of the CAPA for the critical finding. There are a number of possible non-routine post-inspection actions that the IAG may consider, depending on the critical finding and the impact on public safety and data integrity. These include: periodic reporting early re-inspection referral to relevant stakeholders (for example, other regulators/agencies, Health Research Authority (HRA), General Medical Council (GMC), Care Quality Commission (CQC)) suspension of CTA(s) an infringement notice prosecution Fees for GCP inspections Fees for inspections Make payment to MHRA GCP inspection metrics To help you understand the areas where GCP inspectors have found compliance problems during GCP inspections in the UK, the GCP inspectorate produces metrics reports. Infringement notices An infringement notice may be issued when instances of serious or serious and persistent non-compliance with GCP requirements have been identified. Below are all the infringement notices that have been issued for GCP. Some information may be redacted. Redacted information contains elements of personal data, the disclosure of which would be unfair in that it would breach the first principle of the Data Protection Act which says that information must be processed fairly and lawfully Organisation / Person Date Issued Reason Status Celixir 17 July 2024 Regulatory Action Celixir acknowledged the findings of the MHRA’s inspection and proposed a set of corrective and preventative actions (CAPAs) which were comprehensive and included effective measures to ensure the compliance with GCP and trial authorisations and the conformity of the Investigational Medicinal Product Dossier (IMPD) as stated in the Notice and that future clinical trial activity involving Celixir is conducted in a manner that is fully compliant with the Regulations. During this process, Celixir provided all the information to the MHRA and does not hold any information to identify the patient who was dosed (with placebo). The implementation of the CAPAs and compliance with GCP has been independently audited and confirmed by a specialist GCP auditor who has been retained to ensure Celixir’s continued compliance with GCP, trial authorisations and the conformity of the IMPD. Dr David Connell 14 March 2016 Regulatory Action Dr Connell responded to the Infringement notice to confirm that he has relinquished his license to practice medicine in the UK and has no intentions of practicing medicine again in the UK. Dr Connell has confirmed that if he does take part in clinical trials in the UK in the future, he will comply with the conditions of the infringement notice. Dr Connell also confirmed that he did not retain any data or documents from the trials in question, therefore the MHRA also wish to highlight that without any retained data it is not possible to verify the conclusions published from this clinical trial. Mrs Zirka Yousaf 1 July 2016 Regulatory Action Mrs Zirka Yousaf responded to the Infringement Notice to confirm she has implemented an SOP and checklist to ensure future work is adequately documented, will ensure future work commitments are feasible and will not outsource or subcontract work to another contractor. Mrs Zirka Yousaf has confirmed that she will comply with the conditions of the infringement notice. MHRA has verified that there is no impact on patient safety. However, MHRA would also like to remind sponsors that they are ultimately responsible for GCP. Therefore, sponsors have a requirement to ensure oversight of all staff working on their trials, including contractors and those that may be home based. Suitably robust contracts and adequate oversight mechanisms could identify and therefore reduce the likelihood of the non-compliances observed in this infringement notice. Dr Jerome Kerrane 9 November 2017 Regulatory Action Dr Kerrane responded to the Infringement notice to confirm that he has undertaken further training associated with GCP, information governance and financial probity. Dr Kerrane has confirmed that he has not taken part in clinical trial activities since 2015 and has no intentions of undertaking trial work in the future. The MHRA would like to remind investigators of the requirement to comply with the approved trial protocol to ensure the safety of trial participants and the integrity of the data collected; and trial sponsors of the need for effective monitoring. RC ALS / Michael Richard Curran 21 July 2026 Regulatory Action The MHRA issued an infringement notice in relation to the conduct of an unauthorised clinical trial involving Neuralzeta/RCH4. The trial had commenced without the required regulatory authorisation or favourable ethics committee opinion and was not being conducted in accordance with GCP. The notice required the immediate cessation of the supply of Neuralzeta/RCH4 and all activities associated with the unauthorised trial. Any future clinical trial activity in the UK must comply with the applicable regulatory and GCP requirements. Infringement letters Celixir Infringement Notice (PDF, 112 KB, 3 pages) Mrs Zirka Yousaf Infringement Notice (PDF, 3.97 MB, 11 pages ) Dr David Connell Infringement Notice (PDF, 786 KB, 2 pages) Dr Jerome Kerrane Inf
摘要 待译
Information relating to good clinical practice (GCP) inspections.