FDA法規沒有明確規定臨床研究者在文件上的籤名或註明日期，而且也沒有法規禁止臨床研究者使用籤名章。因此，研究中心在如何處理他們研究中心的文件方面可以靈活操作，因為FDA法規並沒有規定必須怎麼做。即便如此，從監管的角度來看，擁有籤名印章訪問權限的任何人都可以使用這個籤名印章，因此，在監管要求驗證由何人完成某項任務和/或何時完成這項任務的情況下，籤名印章使用是不可接受的。證明文件提供方式能夠被驗證是「籤署」文件的個人所獨有。
FDA regulations do not specifically address signing or dating ofdocuments by the clinical investigator, nor do the regulations prohibit the useof stamps by clinical investigators. Sites therefore have flexibility in howthey handle documents at their sites because FDA's regulations do not specifyhow this must be done. That said, from a regulatory standpoint, since stamperscan be used by anyone who gains access to them, the use of stampers would notbe acceptable where verification of who accomplished a task and/or when it wasaccomplished is information required by regulation. Documentation needs to beprovided in a manner that can be verified as unique to the individual who isindicated as "signing" the document.
然而，我們建議，如果您的研究中心正在考慮對其他試驗文件使用日期或籤名印章，從實際角度來看，您可能需要考慮為其應用制定標準操作程序（SOPs）。如果需要使用籤名印章，SOPs應該註明籤名印章任何必要的控制措施，例如：誰被授權使用籤名印章，籤名章保存在何處，籤名印章訪問權限方式是可控的，籤名印章使用的通信類型，和籤名印章使用的條件（例如，提供常規或一般信息的封面欄）。如果您的研究中心隨後遵循您已制定的SOPs，那麼它看起來是可被接受的，並且符合GCP。
However we would suggest that if your site is contemplating the use ofdate or signature stamps for other trial documents, from a practicalstandpoint, you might wish to consider developing standard operating procedures(SOPs) for their use. If a signature stamp were to be employed, the SOPs shouldaddress any necessary controls over the stamp, for example, who is authorizedto use the stamp, where the stamp is stored and how access to the stamp iscontrolled, the type(s) of correspondence on which it may be used, and thecircumstances for its use (e.g., cover letters providing routine or generalinformation). If your site subsequently follows the SOPs that you develop, thenit would appear to be acceptable and in keeping with good clinical practice.
此外，ICH E-6 GCP：綜合指南（GCP相關的FDA官方指南）包含了一些籤名引用和支持文件（4.5.1；4.9.3），但是除第4.8.8節建議知情同意書由受試者或其合法授權代表以及進行知情同意討論的人員籤名並註明日期外，沒有其他關於籤名和註明日期文件的具體討論。如果你想完整地閱讀ICH指南，你可以在以下FDA GCP網站查到它（以及很多其他有用的參考資料）。
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf
In addition, the ICH E-6 Good Clinical Practice: Consolidated Guidance(FDA's official guidance related to GCP) contains a few references tosignatures and endorsing documents (4.5.1; 4.9.3) but no specific discussion ofsigning and dating documents other than Section 4.8.8, which recommends thatthe informed consent form be signed and dated by the subject or the subject'slegally authorized representative, AND by the person who conducted the informedconsent discussion. If you would like to review the ICH guidance in itsentirety, it (and many other helpful references) can be viewed on FDA's GCPwebsite at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf
閱讀以下討論保護研究對象的權利、安全和福利方面的研究者責任的指南連結可能對您有用。
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
It might be helpful to review the guidance link below that discussesInvestigator Responsibilities in Protecting the Rights, Safety, and Welfare ofResearch Subjects.
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
如您所述，書面知情同意書應由受試者或其LAR以及進行知情同意討論的人員籤名並註明日期。
As you state the written informed consent document should be signed anddated by the subject or the LAR and the person who conducted the informedconsent discussion.
您可能想要查閱關於知情同意的FDA信息表。
You may wish to review FDA’s Information Sheet on Informed Consent.
搜索FDA指南文件>知情同意指南-信息表
Search for FDA Guidance Documents > A Guide to Informed Consent -Information Sheet
我希望這些信息是有用的。如果您還有其他問題，請通過
gcp.questions@fda.hhs.gov與我們聯繫。
I hope this information is helpful. Please contact us again atgcp.questions@fda.hhs.gov should you have additional questions.