【ST】 Under what circumstances does the sponsor need to provide the current progress of the trial for a protocol amendment?

刊登日期:2019-11-11  |  點閱次數 : 741 次 

When a protocol amendment is submitted, especially those with major changes to a pivotal study, the sponsor should submit a new version and an old version of the protocol, the amendment summary of changes page and rationale of changes. In addition, the following questions should be explained to clarify the appropriateness of the time point for the changes.

  1. How is the current progress of the clinical trial? How many subjects have been enrolled in the world (and Taiwan)?
  2. Has the study performed any interim analysis? If yes, please specify the date of the interim performed.



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