我有现有数据支持豁免一项研究。我应该如何在 IUCLID 档案中报告这一点？

我有现有数据支持豁免一项研究。我应该如何在 IUCLID 档案中报告这一点？

I have existing data to support the waiving of a study. How should I report this in my IUCLID dossier?

如果您根据 REACH 附件 XI 第 1 节的规定，根据现有数据调整信息要求，则应提供适用数据（例如，横向对比研究、Q(SAR)）作为终点研究记录，并标明相应的“研究充分性”和“信息类型”。您不应将现有数据作为数据豁免记录进行报告。如果您根据相关要求第 2 栏或附件 XI 第 2 节或第 3 节的规定，豁免（省略）信息要求，则应包含一份数据豁免记录，清晰记录豁免的理由。任何支持此理由的可用数据（例如，物质的属性、分类）都应在相关的 IUCLID 部分中报告。为了透明起见，您可能希望使用“交叉引用”字段将此信息链接到数据豁免记录中。有关如何在 IUCLID 中完成终点研究记录的更多信息，请参阅手册“如何准备注册和 PPORD 档案”第 8.6.2 章。

If you are adapting the information requirement based on existing data according to REACH Annex XI section 1, you should provide the applicable data (e.g. read-across study, Q(SAR)) as an endpoint study record, marked with the appropriate ‘Adequacy of study’ and ‘Type of information’. You should not report existing data as a data waiving record.If you are waiving (omitting) the information requirement based on the provisions of Column 2 of the relevant requirement, or Sections 2 or 3 of Annex XI, you should include a data waiving record clearly documenting the justification for the waiving. Any available data that support this justification (e.g. a property of the substance, classification) should be reported in the relevant IUCLID section. For transparency, you may wish to link this information in the data waiving record using the ‘Cross-reference’ field.For more information on how to complete endpoint study records in IUCLID, see the manual How to prepare registration and PPORD dossiers, chapter 8.6.2.