Progress Report
To facilitate the Joint CUHK-NTEC CREC’s continuing review, the Principal Investigator shall have the responsibility to submit a progress report on his/her study to the Joint CUHK-NTEC CREC within one month prior to each deadline for regular continuing review by using the Ethics Renewal & Research Progress Report Form (Progress Report). The progress report shall include updated study information with respect to the study, such as:
- The status of the study (e.g. ongoing);
- The numbers of subjects recruited in, withdrew from and completed the study;
- Summary of major changes to the study;
- Summary of serious adverse events;
- Summary of complaints by subjects; and
- Summary of significant updated information that may affect the safety of subjects or subjects’ willingness to continue participating in the study.
Reminder by the Joint CUHK-NTEC CREC
The Joint CUHK-NTEC CREC will send a reminder to the Principal Investigator about two to three months prior to each deadline for regular continuing review. Notwithstanding the above, Principal Investigators shall anyhow have the responsibility to submit progress reports to the Joint CUHK-NTEC CREC whether or not reminders are received from the Joint CUHK-NTEC CREC.
Progress Report Requirements
The duly completed progress report must be signed by the Principal Investigator and sent to the Joint CUHK-NTEC CREC by mail.
Renewal Form submitted 3 months before the due date will not be considered.
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.
The Supplementary Information Sheet for Ethics Renewal & Research Progress Report Form must be submitted with the progress report if late renewal is reported.
Failure to Submit Progress Report
In the event that a Principal Investigator fails to submit a progress report to the Joint CUHK-NTEC CREC by the deadline for regular continuing review, the Joint CUHK-NTEC CREC may:
- Request suspension of all subject recruitment activities and recruitment of additional subjects into the study;
- 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
- 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 progress report is properly submitted and an approval is received from the Joint CUHK-NTEC CREC.