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

Starting 1^st May 2025, all applicants are required to use the new forms, attach all necessary documents, and upload them via the Joint CUHK-NTEC CREC Submission Portal (Post-approval Activities).

Step 1: Download and complete the e-form (PDF)

Step 2: Select the type of submission (Post-approval Submission)

Step 3: Fill in the details of the submission (CREC Reference No., Name of PI and Email of PI etc.)

Step 4: Upload all the related document(s)

Step 5: Press the Submit button

Step 6: Principal Investigator (PI) must confirm the submission within 14 days

Submissions can be initiated by either the PI or an authorized delegate.

After a submission is made, a confirmation email will be sent to the PI, who must confirm the submission within 14 days.

If the PI does not confirm within this period, the submission will be considered unsuccessful and will be automatically withdrawn.

For SAE submission: Submissions can be initiated by either the PI or an authorized delegate and confirmed by PI or Co-investigator(s).

To facilitate this transition to the new Submission Portal, we will be publishing new forms for post-approval activities. PI will not be required to sign on individual forms, instead, the email confirmation will be recognized as the valid signature.

Please note that all document uploaded to the CREC Submission Portal (Post-approval Activities) should be in PDF format.

Failure to Submit Final Report

In the event that a Principal Investigator fails to submit a Final Report to the Joint CUHK-NTEC CREC by the deadline, the Joint CUHK-NTEC CREC may:

(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.