人民网北京7月29日报道：近日，美国食品药品监督管理局（FDA）对北京协和医院内分泌专业开展的一项名为“评价帕瑞肽长效制剂与奥曲肽长效制剂治疗活动期肢端肥大症安全性和疗效的多中心、随机、盲法研究”的国际多中心临床试验进行了为期五天的视察，并对其总体质量给予了高度评价。
FDA视察人员五天时间，其中很重要的一部分内容，是要对研究团队进行"面试"（Interview）。那么，视察人员都会问哪些问题呢？他们的关注点又在哪里呢？5 k/ E: K, S" u$ X
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It is very important that you prepare the answers to the questions that customarily are put forth by an inspector ahead of time to allow a smooth interaction. Also, practice with your team on the most important issues.
Note that the FDA has establishedpolicies on refusals to provide information or documents. If during the inspection,access to records or copying of records is refused for any reason or there iswhat is called a de facto refusal, the FDA investigator will immediately reportto his/her superiors, which may prompt additional actions. If the investigatorsite does not have the documentation requested for any reason (e.g., as lost, misplaced,or never obtained) do not refuse to provide it: explain that the document waslost or misplaced and make all efforts to find it while the inspector is at thesite.
Many investigators may feel uneasy to provide access to patient files in light of confidentiality of medical records; however, the investigator must recall that when he/shesigned Form 1572, he/she agreed to provide all records or reports to the inspector and that the patient files are part of those records.
During the establishment inspection, the inspector may interview the personnel to verify the following activities:
1.Who Did What?Who performed the various clinical trial activities, such as who obtained informedconsent, who verified inclusion and who collected adverse event data.Have prepared an organizational chart, with the main activities.
2.Delegation of authority
(a) How the clinical investigator supervised the conduct of theinvestigation. Have available minutes of internal meetings and principal investigator’s notes and follow-ups.
(b) Determine whether authority for the conduct of the various aspects of the study was delegated properly so that the investigator retained control and knowledge of the study. Have available the procedure for delegationof authority and the documents delegating responsibilities to the various parties, such as contract agreements or delegation letters.
3.Specific Site of Study Activities. Where specific aspects of the investigation were performed: like logs, charts, appointment schedules, and lab requisitions and results.
4.Data Recording. How and where data were recorded. Have available the patient files or charts as well as the consent forms and case report forms.
5.Drug Accountability. Accountability for the investigational product. Have all updateddrug accountability logs available.
6.Monitoring
(a) The monitor’s communications with the clinical investigator,such as emails, letters, and other communications.
(b) The monitor’s evaluations of the progress of the investigation, such as progress letters or reports.
(c) Determine how (e.g., telephone, memo, etc.) the monitor explained to the clinical investigator the status of the test article, nature of the protocol, and the obligations of a clinical investigator. Depending on the sponsor, this may be through a verbal interview or a follow-up letter after the monitoring visit.
7.Investigator’s Supervision
(a) Whether there was adequate supervision and involvement in the ongoing conduct of the study. This refers to documents showing the investigator’s involvement (such as visit reports, follow-ups and minutes ofmeetings conducted with clinical trial personnel).
(b) Whether there was adequate supervision or oversight of anythird parties involved in the conduct of a study (contractors, CROs) to the extent that such supervision or oversight was reasonably possible. This willdepend on the activity contracted; however, the investigator must have an answer as to how he/she supervised the activity.
8. The FDA inspector will also try to determine whether the investigator discontinued the study before completion.
9. The FDA inspector will request a list of the names and addresses of the facility( ies) performing laboratory tests.
(a) If any laboratory testing was performed in the investigator’s own facility, determine whether that facility is equipped to perform each test specified. This refers to certificates of accreditation accrediting thefacility for the time the study took place or is taking place.
(b) List the name(s) of individuals performing such tests and indicate their position. This list should also include licenses that the personnel may have to hold to perform specific activities (such as a licensed pathologist).
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