临床试验中如何规范适用签名和日期印章？一起来看看FDA是如何建议的？

问题6.65 ：在临床研究中使用签名或日期印章的规则是什么，使用此类印章是否符合GCP标准？What are the rules regarding the use of a signature or date stamp in clinical studies, and is the use of such stamps consistent with GCP standards?

答复： 在最近对有关使用日期印章的问题的答复中，FDA表示，“[机构]法规没有专门针对临床研究人员签署名字或日期的文件，法规也没有禁止临床研究人员使用日期印章。因此，研究中心在处理其文件方面具有灵活性，因为FDA的规定没有规定必须如何做到这一点。In a recent response to a question regarding the use of date stamps, the FDA stated that, “[agency] regulations do not specifically address the signing or dating of documents by the clinical investigator, nor do the regulations prohibit the use of date stamps by clinical investigators. Sites therefore have flexibility in how they handle documents at their sites because FDA’s regulations do not specify how this must be done.

[我们]建议，如果您的研究中心正在考虑使用日期或签名印章，从实际操作的角度来看，您可能希望考虑制定标准操作程序（SOP）以供使用。如拟使用签名印章，标准操作程序应处理对印章的任何必要管制，例如，谁获授权使用印章、印章存放地点及如何控制对印章的接触、可使用印章的往来文件的类型，以及使用印章的情形（例如， 提供常规或一般信息的封也面）。如果您的研究中心随后遵循您建立的SOP，那么它似乎是可以接受的，并且符合良好的临床实践。[We] would suggest that if your site is contemplating the use of date or signature stamps, from a practical standpoint, you might wish to consider developing standard operating procedures (SOPs) for their use. If a signature stamp were to be employed, the SOPs should address any necessary controls over the stamp, for example, who is authorized to use the stamp, where the stamp is stored and how access to the stamp is controlled, the type(s) of correspondence on which it may be used, and the circumstances for its use (e.g., cover letters providing routine or general information). If your site subsequently follows the SOPs that you develop, then it would appear to be acceptable and in keeping with good clinical practice.”

在实践中，一些临床环境允许在病历上使用橡皮图章。然而，当使用印模时，需要在印痕的文件上签署姓名序缩写，并且必须有与印章签名与原始签名相匹配的支持文件。In practice, some clinical settings permit the use of a rubber stamp on medical records. When it is used, however, the impression should be initialed in script, and there must be supporting documentation matching the stamp signature with an original signature.

橡皮图章应以非常有限的方式用于临床研究，即在医院允许的情况下，当在医院病历上使用橡皮图章，需要签姓名缩写和注明日期。作为研究中心选择的流程的一部分，申办者应评估研究中心创建和维护医疗记录的方法。如果研究者办公室/诊所，或参与医院常规使用橡皮图章，则应在该中心开研究之前与研究中心工作人员讨论有关其使用的规则。Rubber stamps should be used in clinical studies in a very limited manner—that is, on hospital medical records if permitted by the hospital and if initialed and dated. As part of the site selection process, the sponsor should evaluate the site’s methods for creating and maintaining medical records. If a rubber stamp is routinely used at the investigator’s office/clinic，or participating hospital, then the rules regarding its use should be discussed with site staff prior to the study’s initiation at that site.

印章不能应用于关键文件，例如 FDA 1572 表格 - 研究者声明、方案签名、财务披露表或知情同意书。 根据FDA2010年5月名为“常见问题——研究者声明（FDA 1572表格）”的指南，填写完整的1572表“必须由研究者签署并注明日期（手写或使用可接受的电子方法）。A stamp should not be used for key documents such as the Form FDA 1572-Statement of Investigator, protocol signatures, the Financial Disclosure Form or informed consents. According to FDA’s May 2010 guidance titled, “Frequently Asked Questions—Statement of Investigator (Form FDA 1572),” a completed 1572 “must be signed and dated by the investigator (either by hand or using an acceptable electronic method).”