Completed / Abandon Application
Final Report
The Joint CUHK-NTEC CREC shall have the responsibility to follow each approved clinical study until its completion or early termination. A Principal Investigator shall have the responsibility to submit a Final Report on his/her study to the Joint CUHK-NTEC CREC within two months from the date of formal closure of the study by using the Ethics Renewal and Progress Report Form (Final Report). The Final Report shall include a summary of study information, such as:
- (a) the status of the study (e.g. completed or prematurely terminated);
- (b) the numbers of subjects recruited in, withdrew from and completed the study;
- (c) summary of serious adverse events;
- (d) summary of complaints by subjects; and
- (e) summary of significant updated information that may affect the safety of subjects.
Final Report Requirements
The duly completed Final Report must be signed by the Principal Investigator and sent to the Joint CUHK-NTEC CREC by e-mail.
Applicant is required to use the new forms, attach all necessary documents and send to crec9@cuhk.edu.hk. This email should be sent by the Principal Investigator (PI); if it is sent by the delegate, PI should be copied in (cc).
- Starting 1st January 2025, all submissions must be submitted to CREC via email (crec9@cuhk.edu.hk). During this period, CREC will accept submission using either old or new forms.
- Starting 1st February 2025, CREC no longer accept submissions made using the old forms. Applicant is encouraged to make the necessary adjustments before this deadline.
- If applicant have already signed on the old forms, scanned versions of these forms along with the documents are required to be submitted. Applicant is reminded to retain the original copy of the signed forms.
- The new forms are interactive PDF forms that allows applicant to provide electronic signature via Digital ID, which is the only acceptable electronic signature.
- Please note that typed signatures or images of signatures will not be considered valid.
- If applicant is unable to sign on the new forms electronically, scanned copy of page with original signature is acceptable only with the interactive PDF form attached in the email.
An updated copy of Insurance Certificate should be submitted if applicable.
An updated copy of Clinical Trial Certificate should be submitted if applicable.
Failure to Submit Final Report
- (a) refuse accepting any new application for initial review of clinical study submitted by the Principal Investigator and his/her participation in any new clinical study (whether as Principal Investigator, Co-Investigator or otherwise); and/or
- (b) notify the issue to the other research ethics committees under the HA, which may refuse his/her participation in any new clinical study (whether as Principal Investigator, Co-Investigator or otherwise)
until the Final Report is properly submitted and an acknowledgement is received from the Joint CUHK-NTEC CREC.