在 IUCLID 中准备“数据豁免理由”时，如何克服“其他”选项旁边的文本字段中的字符限制？

在 IUCLID 中准备“数据豁免理由”时，如何克服“其他”选项旁边的文本字段中的字符限制？

How can I overcome the character limit in the text field next to the option 'other' when preparing a ‘Justification for data waiving’ in IUCLID?

如果“其他：”值旁边的自由文本字段中的字符限制不允许您提供足够的信息来证明豁免的合理性，您可以使用管理数据部分中的以下 IUCLID 字段：选择列表值“其他：”下方的“备注”字段“信息类型说明” - 此字段具有更高的字符限制，允许更长的论证。此外，如果您需要以报告或示意图的形式提供更多信息，您可以使用“附加说明”字段附加支持文件。要引用档案中其他位置提供的信息，您还可以使用“交叉引用”字段。但是，请务必注意，数据豁免的主要论证必须包含在相关终点研究记录的“其他”、“备注”或“信息类型说明”字段中。仅引用档案中的其他地方（例如另一部分、终点摘要）或附件并不是证明数据豁免的有效方法，并且这样的记录将无法通过完整性检查。

If the character limit in the free text field next to the value ‘other:’ does not allow you to provide sufficient information to justify the waiving, you can use the following IUCLID fields in the Administrative data part:‘Remarks’ field below the picklist value ‘other:’‘Justification for type of information’ – this field has a higher character limit and allows for a longer argumentation.In addition, should you need to provide further information in the form of a report or schematic, you can use the field ‘Attached justification’ to attach the supporting document. To refer to information provided elsewhere in the dossier, you can also use the field ‘Cross-reference’.However, it is important to note that the main argumentation for the data waiving has to be included in the fields ‘Other’, ‘Remarks’ or the field ‘Justification for type of information’ of the relevant endpoint study record. Only referring to somewhere else in the dossier (e.g. another section, an endpoint summary) or to an attachment is not a valid approach to justify the data waiving and such a record will not pass the completeness check.