The following aspects should be considered when determining risk and control measures:

在确定风险和控制措施时，应考虑以下方面：

· Is original data (including the original data format) available for checking;

原始数据（包括原始数据格式）是否可供检查。

The format of the original data (electronic or paper) should be preserved, and available to the data reviewer in a manner which permits interaction with the data (e.g. search, query). This approach facilitates a risk-based review of the record, and can also reduce administrative burden for instance utilising validated audit trail 'exception reports' instead of an onerous line-by-line review.

原始数据的格式（电子或纸质）应该被保留，并以允许与数据交互（如搜索、查询）的方式提供给数据审查员。这种方法有利于对记录进行基于风险的审查，也可以减少行政负担，例如利用有效的审计跟踪 "例外报告 "而不是繁琐的逐行审查。

· Are there any periods of time when data is not audit trailed;

是否有任何时间段的数据没有被审计追踪。

This may present opportunity for data amendment which is not subsequently visible to the data reviewer. Additional control measures should be implemented to reduce risk of undisclosed data manipulation.

这可能为数据修改提供了机会，而数据审查员随后并不了解这些修改。应实施额外的控制措施，以减少未披露的数据操作的风险。

· Does the data reviewer have visibility and access to all data generated;

数据审查员是否对产生的所有数据有可见性和访问权。

This should include any data from failed or aborted activities, discrepant or unusual data which has been excluded from processing or the final decision-making process. Visibility of all data provides protection against selective data reporting or 'testing into compliance'.

这应该包括来自失败或中止的活动的任何数据、被排除在处理或最终决策过程之外的不一致或不寻常的数据。所有数据的可见性提供了对选择性数据报告或 "测试遵守 "的保护。

· Does the data reviewer have visibility and access to all processing of data;

数据审查员是否对所有数据的处理有可见性和访问权。

This ensures that the final result obtained from raw data is based on good science, and that any data exclusion or changes to processing method is based on good science. Visibility of all processing information provides protection against undisclosed 'processing into compliance'.

这确保了从原始数据获得的最终结果是基于科学性的，而任何数据的排除或处理方法的改变都是基于科学。所有处理信息的可见性针对防止未披露的 "合规处理"提供了保障。