Amendment Application

Amendment Application

Implementation of Amendments / Changes

Investigators and study personnel have the responsibility to adhere to the study protocol and other study documents/materials approved by the Joint CUHK-NTEC CREC. No amendment or change to any approved study document/material shall be implemented without the Joint CUHK-NTEC CREC’s approval, except:

  • where necessary to eliminate any immediate hazard to the subjects; or
  • if an amendment/change is only of an administrative or logistical nature (e.g. correction of typo errors).

Application for Amendments / Changes

In the event that any amendment or change needs to be made to any study document/material, the principal investigator (PI) shall submit an application for study amendment(s)/change(s) to the Joint CUHK-NTEC CREC by using the amendment form.

Requirements for Amendment / Changes

Online Application via the Portal is required (if applicable). 1 set of hardcopy (original) of Amendment Application Form printed from Portal and relevant documents are required. If supplementary information is to be provided, Amendment Application Form could also be attached.

The Principal Investigator should check the following points before submitting the Amendment Application:

  • Approval Date : Expired study will not be reviewed. The PI has to attach the completed “Ethics Renewal & Research Progress Report Form” if the study is expired or going to be expired soon.
  • Change of PI : The current PI should submit the CV of the new PI and Conflict of Interest Declaration Form, obtain the original signature of new PI (Part IV Declaration by Investigators of the Application Form) and COS and/or Department Head of new PI for endorsement.
  • Add Co-Investigator (Co-I): The PI should submit the CV of the new Co-I and Co-I’s original signature (Part IV Declaration by Investigators of the Application Form) and the Conflict of Interest Declaration Form.
  • Add Applying Site(s) and/or Collaborating Site(s): The PI should obtain the original signature of COS and/or Department Head of the added site(s) for endorsement.
  • Safety reports and submission of insurance certificate will not be considered as an amendment application, the Joint CUHK-NTEC CREC will issue an acknowledgement letter to PI (if applicable).
  • All amendment cases due to updating of Investigator’s Brochure will be reviewed through an expedited review process.
  • Amendment Form should be signed by the PI. If changing the PI as PI has retired, the COS or Department Head of PI may sign on behalf of PI. If the PI is on leave, the Co-I may sign on behalf of the PI.