Question: ArrayWhat do data trajectories and editing trajectories refer to, and the difference between them and audit trajectories? (GCP No. 57 of 2020, Article 36 (5)) @ @ The audit trail includes the entry, editing, and modification trajectories of all data. The Chinese GCP and ICH GCP are consistent, with a special emphasis on data trajectory and editing trajectory, aiming to emphasize that there should be no hard deletion, that is, permanent deletion of data without any traces of data entry.
Answer:
稽查轨迹包括了所有的数据的录入、编辑轨迹和修改轨迹。中国GCP和ICH GCP一致,特意强调数据轨迹和编辑轨迹,旨在强调不能有hard deletion(完全删除),即数据永久删除,没有数据录入过的痕迹。