接上文21CFR PART 312 -§ 312.66 Assurance of IRB review. IRB审查保障（中英文）
§ 312.68 Inspection of investigator's records and reports. 检查研究者的记录和报告
An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
研究者应根据FDA任何适当授权的官员或雇员的要求，在合理的时间，允许该官员或雇员访问、复制和核实研究者根据§312.62所做的任何记录或报告。除非特定个人的记录需要对案例进行更详细的研究，或者除非有理由相信这些记录不代表实际的案例研究，或者不代表实际的结果，否则研究者不需要透露受试者的姓名。
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