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
Starting 1st 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If the PI does not confirm within this period, the submission will be considered unsuccessful and will be automatically withdrawn.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 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.