02 Protocol Amendment Review(變更案)

Important Notes:

  1. Forms 01-02 for amendments should be downloaded from the official website (please fill them out in Chinese). The previous version of the document must match the approved version, and the approved version should be used to make changes for the new version. For changes in the revised document, please mark changes using underlining and highlighting, and update the version date in the footer and filename.
  2. Please arrange all electronic files in the order of this check list and email them to nthurec@my.nthu.edu.tw. Submit hard copies only after confirming that no additional documents are needed. Hard copies should be mailed to: No. 101, Guangfu Road Section 2, Hsinchu 30013, Taiwan, National Tsing Hua University / Research Ethics Office (Room 116, 1st Floor, previous Innovative Incubation Center)
  3. Before upload to the review system, you can confirm contents with the office by email. When documents confirm without revise, you can upload to the review system.

The principal investigator must sign the application form, as well as the revised/newly added documents, to show responsibility.

Check List of Submission Documents for the Xth Research Protocol Amendment Review

Form Name

Remarks
  1. Research Protocol Amendment Application form

PI’s signature is required
  1. Before and after comparison table

  1. New documents added this time:

Documents deleted this time:

PI must sign on the first page and include the version and date.
  1. Revised version documents

£Research Protocol

£Informed Consent

£Survey/£Interview outline

£Recruitment advertisements

£Other documents:

PI must sign on the first page of each revised document.
  1. New research member CV and REC training certificate

Please provide copies of research ethics training certificates from within the last two years, covering at least six hours of training.

Only a CV is required for newly added co-/sub-investigators.
  1. Previous approvals

Includes New Protocol Review Approvals, Continuing Review Approval Notification, and Research Protocol Amendment Approval Notification.
  1. Supplementary files or relevant certificates

(e.g. Funding approvals, safety or licensing documents for devices)

If changes or additions are made, please attach them.
  1. Previous documents

If documents are modified, please attach the previously approved version (pre-amendment).