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 mail.

An updated copy of Insurance Certificate should be submitted if applicable.

An updated copy of Clinical Trial Certificate should be submitted if applicable.

An updated copy of Indemnity Form signed by Knowledge Transfer Office (KTO) of CUHK and Hospital Chief Executive (HCE) / Cluster Chief Executive (CCE) of HA should be submitted if applicable.

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.