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研究数据需要保存多长时间？

Q：Good day，I have an Investigator who has maintaineddata from clinical trialsfor over ten years. He would like to destroy these files so as to free up space for current trials he is involved with. I just want to make sure we follow all Federal regs in this process. Please provide a source for this procedure(s).

你好，我认识的一名研究者，已经 保存临床试验中的数据十多年了。他想销毁这些文件，以便为他当前参与的试验腾出存储空间。我想确保我们在此过程中需要遵循哪些相关规定。请提供此流程规定的来源。

A：FDA regulations on investigator record retention for clinical trials are as follows:

For drug and biologic studies, 21 CFR 312.62(c) states: "Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified."

FDA关于临床试验研究者记录保存的规定如下：

对于药物和生物学研究，21 CFR 312.62（c）规定：“记录保存。研究者应在自药品上市申请获批之日起的两年内，保存所要求留存的记录；如果未提交申请或申请未被批准用于此类适应症，则在研究结束两年后通知FDA。”

For device studies, 21 CFR 812.140(d) states: "Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol."

对于 器械研究，21 CFR 812.140（d）规定：“保存期限。研究者或申办方应在研究期间保留本章节所要求的记录，直至研究终止或完成后两年、上市前申请获批或通知药物研究方案完成后两年。”

As you will note, the retention period is dependent on whether the data will be used to support a marketing application with FDA. The sponsor is usually the only party totally knowledgeable about the status of its investigational product (e.g., whether it has been approved for marketing, whether the sponsor no longer intends to seek marketing approval, etc.). Therefore, it is best to check with the study sponsor regarding the need to retain the study records.

正如您所说，保存期限取决于数据是否将用于支持FDA上市申请。研究者通常是唯一完全了解其研究药品状态的一方（例如，是否已经批准上市，申办方是否不再需要上市批准等）。因此， 最好与申办方确认是否需要保留研究记录。

FDA does not have specific guidelines on how records should be destroyed. When FDA regulations are silent, sites are free to develop their own standard operating procedures to handle specific situations. Maintaining confidentiality of subject identities and records is important

FDA没有关于如何销毁记录的具体指南。若FDA法规未提及，机构可以设定自己的SOP来处理特定情况。为受试者的身份和记录保密是非常重要的。

今天我们就学这么多，感谢您的聆听，临床试验听听看，我们下期再见。

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