接上文21CFR PART 312 -§ 312.62 研究者记录和记录保存（中英文）
§ 312.64 Investigator reports. 研究者报告
(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.
进展报告。 研究者应当向申办方提供所有报告，申办方负责收集和评价所获得的结果。按§312.33要求，申办方需向FDA提交关于临床研究进展的年度报告。
(b) Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis). In that case, the investigator must immediately report the event to the sponsor. The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol.
安全性报告。 研究者必须立即向申办方报告任何严重不良事件，无论其是否被认为与药物有关，包括方案或研究者手册中列出的不良事件，并且必须包括对药物是否有合理可能性导致该事件的评估。严重不良事件(如全因死亡)的研究终点必须按照方案报告，除非有证据表明药物与不良事件(如过敏性死亡)之间存在因果关系。在这种情况下，研究者必须立即向申办方报告该事件。研究者必须记录非严重不良事件，并按照方案中规定的报告时间表向申办方报告。
(c) Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator's participation in the investigation.
最终报告。 研究者应在其完成研究后不久向申办方提供一份适当的报告。
(d) Financial disclosure reports. The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under part 54 of this chapter. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
财务披露报告。临床研究者应向申办者提供足够准确的财务信息，以便申办方按照本章第54部分的要求提交完整准确的证明或披露声明。如果在研究过程中以及研究结束后1年内发生任何相关变化，临床研究者应及时更新这些信息。
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