FDA检查 - 监管服务 - 临床试验资源中心 - UTHealth

FDA检查的动作

First,提醒我们upon receiving the call or letter from the FDA to schedule the inspection. Please fill outthis formimmediately.

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的following actions are to be taken during an FDA inspection from the time the FDA inspector is greeted to the time the exit interview is conducted and a response to the FDA’s observations are made.

Investigators are required to permit the FDA to inspect and copy any records pertaining to the investigation including, in certain situations, those which identify subjects.

Designate a person to serve as escort who will oversee the inspection (usually the research coordinator for the study). The FDA investigator must not be permitted free access to areas where files are kept, and the escort serves as an institutional monitor as well as guide and general study contact person.

Before the site inspection,complete theFDA AUDIT CHECKLIST，和identify records the FDA are likely to audit,including:
1. Identify all subjects, enrollment/screening log, and ALL Informed Consents.
2. Selected Case Report Forms and all supportive source documentation.
3. 将这些记录和您的评论隔离，以便容易访问，但不要自愿将其列出给检查员。
  
  Always等待特定请求提供信息。

检查员的到来Please also refer to your department policy for how to deal with site inspections.
1. 的re may be times when persons at other institutions (e.g., department directors at MHHS) should be notified that the FDA is conducting an inspection in the building.
2. 如果将日志中的符号用于练习：如果检查员不登录，请在名称，日期/时间，目的和伴游名称的日志中记录注释。
3. 的escort will walk the inspector to an appropriate meeting room. The inspector will present his/her credentials to verify that they are in order; do not expect the investigator to permit a copy to be made of the badge/credentials.
4. 的inspector will then present a Notice of Inspection (482) to the Principal Investigator, this notice authorizes the inspection and its presentation officially begins the inspection.
5. 检查员将解释检查的预期目的和范围，然后要求PI总结研究。
的inspection
1. 护送应该安排一个comfortable work area for the FDA inspector(s) for the duration of the inspection. The room must contain no confidential records, including clinical or research related. The inspector should be accompanied by the escort or designee at all times while in the presence of study related documents, samples, or other confidential information. If the inspector needs to make a phone call and requires some privacy, they should have access to a “sterile” room (no study related information is present) or public area where they can conduct their business. In general, while an inspector is here in an official capacity, they should not be left alone.
2. 检查员绝不能访问主机未具体提供的任何站点记录。标准程序是为了让检查员要求文件进行审查，从“一般”研究材料（包括监管文档重点固定器）开始，然后所有已签署的知情同意书，然后对特定的患者记录进行采样。研究财务和人员记录不包括在标准检查中。
3. 的Principal Investigator should set aside time each day to talk with the inspector, as well as being available for questions that may arise.
4. 的escort’s role is to coordinate all FDA requests and see that the inspector’s questions are answered honestly and completely. Listen to the question; answer the question that was asked. Defer to others if you don't know; when possible use documents already provided for support of answers. Stop when the question is fully answered. There is nothing wrong with silence: when you have answered, wait for the next questions.
5. 如何回答FDA问题
  1. Be concise; answer only the question that is asked.
  2. Always be clear with the answers to questions.
  3. 保持积极和自信。
  4. 如果可能的话，采取纠正措施，仅对您可以交付的东西进行。
  5. DO NOT volunteer information. DO NOT guess or speculate.
  6. DO NOT lie. DO NOT argue.
  7. DO NOT panic.
  8. 不要签署宣誓书。
6. 检查文件
  1. Escort the inspector to an information sterile room away from sources of casual conversation to review requested documents. Always sequester the reviewer in an isolated room and bring the requested documents to them..
  2. 仅提供检查员专门要求的文件进行审查。护送可能需要从医院或诊所记录中获取患者记录，以补充或证实研究记录。beplay苹果手机能用吗
  3. Gather the documents requested for review. When documents are copied for inspectors, either a copy is also made to retain or identify each copied document by maintaining an inspection record log. All copies provided should be stamped “Confidential”. Usually copies are provided without charge to the FDA; however, if the inspector requests an inordinate number of copies, notify the inspector that an invoice will be provided.
  4. Documents that the inspector isnotentitled to review or copy: financial, personnel (except for training/qualification records), and internal audits (section 704(a) FDC Act).
7. Photographs- If the FDA insists on taking photographs, take duplicates at the same time
8. Samples- If the FDA requests a reasonable quantity of samples, fill the request but pull identical samples to retain. Ask the FDA to issue a receipt for the samples (form 484). Depending on the nature of the samples requested, advise the FDA that an invoice will be presented.

Exit Interview
1. 的FDA will usually hold an exit interview at the conclusion of the inspection. The escort, Principal Investigator, a representative from Institutional Compliance, and other individuals as appropriate should be notified of the time and place and expect to attend. During this exchange, if serious deficiencies have been found during the inspection, an Inspectional Observations form 483 will follow from the regional office, listing the deficiencies. If no deficiencies are found, or the inspector has comments that she or he believes are not serious enough to warrant a 483, no form will be issued.
2. During the exit interview:
  首席调查员将寻求纠正调查结果中的任何错误。

Both the FDA and Principal Investigator will make sure everything is clear and understood.
Observations, comments, and commitments will be noted in the escort inspection notes.

对FDA 483的回应
1. PI或指定的应起草对FDA 483的回应。PI负责将响应草案发送给临床试验中心的UTHealth部门联系人，机构合规性以及审计和咨询服务。PI还负责将书面响应发送给FDA。
2. 的written response should include specifics:
  1. Determine if a finding was an oversight/one-time occurrence; or systemic, where a change of procedure is indicated.
  2. 描述纠正措施：包括拟议回应会解决问题的原因；以及校正的现实时间表。
  3. If the PI disagrees with an observation: respond factually, providing clear and verifiable evidence.
  4. Address each particular observation or finding, point by point.
  5. 答复应在两周内发送。在办公室中保留最终签名响应的副本。

6. To request an EIR (establishment inspection report)

的FDA inspector will file an EIR within approximately 30 days. This report is subsequently available through FOI. It may be requested from:

Freedom of Information
Division of Dockets Management
5630 Fishers Lane, Room 1061, Mail Stop HFA-305
罗克维尔，医学博士20852。

7.机构跟进

Please provide a copy of thefinalestablishment inspection report (EIR) and/or the Inspectional Observation Form 483 upon receipt to the UTHealth departmental contacts of the Clinical Trials Resource Center, Institutional Compliance, and Auditing and Advisory Services.

Related documents:
General Guidance for Site Inspections
FDA Inspection Information
FDA检查清单
FDA Inspection Reporting

ADDITIONAL RESOURCES

Clinical Trials Resource Center (CTRC)
7000 Fannin Street，Suite 795
德克萨斯州休斯顿77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu