接上文21CFR PART 312 -§ 312.69 受控物质处理（中英文）
§ 312.70 Disqualification of a clinical investigator. 取消临床研究者的资格
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding. If an explanation is offered but not accepted by the applicable Center, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.
如果FDA有信息表明研究者(包括申办方-研究者)多次或故意不遵守本章第50部分或第56部分的要求，或者多次或故意在任何要求的报告中向FDA或申办方提交虚假信息，CDER或CBER将向研究者发送投诉事项的书面通知，并为研究者提供书面解释该事项的机会，或根据研究者的选择，在非正式会议上解释该事项。如果提供了解释并被中心接受，中心将停止取消资格的程序。如果提供了解释，但不被中心接受，研究者将有机会根据本章第16部分进行监管听证会，讨论研究者是否有资格根据本部分接收试验用药物，是否有资格进行任何临床研究，以支持FDA监管产品的研究或上市许可申请。
(b) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with the requirements of this part, part 50 or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing institutional review boards (IRBs) that the investigator is not eligible to receive test articles under this part. The notification to the investigator, sponsor, and IRBs will provide a statement of the basis for such determination. The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.
在评估了所有可获得的信息，包括研究者提供的任何解释后，如果官员确定研究者多次或故意不遵守本章第50部分或第56部分的要求，或者多次或故意在任何要求的报告中向FDA或申办方提交虚假信息，则官员将通知研究者、指定该研究者为任何临床研究参与者的申办方，以及IRB，认为按照本部分规定研究者没有资格接受试验用药物。发给研究者、申办方和IRB的通知将提供此类决定的基础声明。该通知还将解释，根据本部分确定没有资格接受试验用药物的研究者将没有资格进行任何支持FDA监管产品的研究或上市许可申请的临床研究，包括药物，生物制品，医疗器械，新动物药，食品(包括有营养含量声明或健康声明的膳食补充剂)，婴儿配方奶粉，食品和颜色添加剂，以及烟草制品。
(c) Each application or submission to FDA under the provisions of this chapter containing data reported by an investigator who has been determined to be ineligible to receive FDA-regulated test articles is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the continuation of an investigation or essential to the approval of a marketing application, or essential to the continued marketing of an FDA-regulated product.
根据本章规定，向FDA提交的每一份申请或提交的材料，如果研究者被确定为没有资格接受FDA监管的试验用药物，则这些申请或材料必须接受审查，以确定研究者提交的数据是否不可靠，这些数据对研究的继续进行或批准上市申请至关重要，或对FDA监管产品的继续销售至关重要。
(d) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Commissioner will notify the sponsor, who shall have an opportunity for a regulatory hearing under part 16 of this chapter. If a danger to the public health exists, however, the Commissioner shall terminate the IND immediately and notify the sponsor and the reviewing IRBs of the termination. In such case, the sponsor shall have an opportunity for a regulatory hearing before FDA under part 16 on the question of whether the IND should be reinstated. The determination that an investigation may not be considered in support of a research or marketing application or a notification or petition submission does not, however, relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation.
如果将研究者提交的不可靠数据在考虑之外后，官员确定剩余的数据不足以支持继续研究是合理安全的，则官员将通知申办方，申办方将有机会根据本章第16部分举行监管听证会。但是，如果存在对公众健康的危险，则官员应立即终止IND，并将该终止通知申办方和IRB。在这种情况下，申办方应该有机会在FDA根据第16部分就IND是否应该恢复的问题举行监管听证会。然而，研究不被视为支持继续研究或上市申请或通知或申请提交的决定并不免除申办方根据任何其他适用法规向FDA提交研究结果的任何义务。
(e) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to withdraw approval of the product in accordance with the applicable provisions of the relevant statutes.
在研究者提交的不可靠数据被排除在考虑之外后，如果官员确定继续批准该产品是不合理的，则官员将根据相关法规的适用规定撤销该产品的批准。
(f) An investigator who has been determined to be ineligible under paragraph (b) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, solely in compliance with the applicable provisions of this chapter.
根据本节(b)段被确定为不合格的研究者，当官员确定研究者已经提供了充分的保证，即保证将使用所有试验用药物，并将进行任何临床研究以支持FDA监管产品的研究或上市许可申请，并且完全符合本章的适用规定时，可以恢复其资格。
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