Submission Information
Address
Joint CUHK-NTEC Clinical Research Ethics Committee
8/F, Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital
Shatin, Hong Kong
香港沙田威爾斯親王醫院呂志和臨床醫學大樓8樓
香港中文大學 – 新界東醫院聯網臨床研究倫理 聯席委員會
Enquiry regarding Clinical Research Ethics
For enquiry regarding Clinical Research Ethics, please call 3505 3935 or email crec@cuhk.edu.hk.
Initial Review Application Fee
HK$16,000 will be charged for Company-sponsored Studies.
Annual Maintenance Fee
HK$5,000 per study site, the recurring annual maintenance fee has to be paid once a year, until submission of the final report of the study.
An additional fee (Phase 1 Study)
HK$20,000 will be charged for Phase 1 Studies that require Joint Scientific Committee Review.
An amendment fee
HK$16,000 will be charged for signification changes to the Study Protocol that require the Joint CUHK-NTEC CREC to perform another full review.
Deadlines for Submission in 2025
The monthly Joint CUHK-NTEC CREC meeting is normally held on the first Tuesday of each month. However, the meeting date may change according to unforeseen circumstances. Deadline for submission of applications is on the 15th of each month irrespective of the meeting date. However, if the 15th of a particular month falls on a Saturday, Sunday or public holiday, the submission date may be changed to the prior or next working day.
DATE OF CREC MEETING | DEADLINE FOR APPLICATION SUBMISSION |
|---|---|
| 07 Jan 2025 (Tue) | 16 Dec 2024 (Mon) |
| 04 Feb 2025 (Tue) | 15 Jan 2025 (Wed) |
| 04 Mar 2025 (Tue) | 14 Feb 2025 (Fri) |
| 01 Apr 2025 (Tue) | 14 Mar 2025 (Fri) |
| 06 May 2025 (Tue) | 15 Apr 2025 (Tue) |
| 03 Jun 2025 (Tue) | 15 May 2025 (Thu) |
| 08 Jul 2025 (Tue) | 16 Jun 2025 (Mon) |
| 05 Aug 2025 (Tue) | 15 Jul 2025 (Tue) |
| 02 Sep 2025 (Tue) | 15 Aug 2025 (Fri) |
| 03 Oct 2025 (Fri) | 15 Sep 2025 (Mon) |
| 04 Nov 2025 (Tue) | 15 Oct 2025 (Wed) |
| 02 Dec 2025 (Tue) | 14 Nov 2025 (Fri) |
| TBC | 15 Dec 2025 (Mon) |
* Please note that this table will be updated periodically.
Date of Phase 1 Meeting in 2025
The monthly Joint CUHK-NTEC CREC Phase 1 meeting is normally held on the first and third Wednesday of each month.
DATE OF PHASE 1 GROUP 1 MEETING | DATE OF PHASE 1 GROUP 2 MEETING |
|---|---|
| 08 Jan 2025 (Wed) | 22 Jan 2025 (Wed) |
| 05 Feb 2025 (Wed) | 19 Feb 2025 (Wed) |
| 05 Mar 2025 (Wed) | 19 Mar 2025 (Wed) |
| 02 Apr 2025 (Wed) | 16 Apr 2025 (Wed) |
| 07 May 2025 (Wed) | 21 May 2025 (Wed) |
| 04 Jun 2025 (Wed) | 18 Jun 2025 (Wed) |
| 02 Jul 2025 (Wed) | 16 Jul 2025 (Wed) |
| 06 Aug 2025 (Wed) | 20 Aug 2025 (Wed) |
| 03 Sep 2025 (Wed) | 17 Sep 2025 (Tue) |
| 08 Oct 2025 (Wed) | 22 Oct 2025 (Wed) |
| 05 Nov 2025 (Wed) | 19 Nov 2025 (Wed) |
| 03 Dec 2025 (Wed) | 17 Dec 2025 (Wed) |
| 07 Jan 2026 (Wed) (TBC) | 21 Jan 2026 (Wed) (TBC) |
* Please note that this table will be updated periodically.
Submission Requirements
Initial Application
Online Application via the Portal is required. Starting 1st January 2025, hard copy of the new submission will not be required to be submitted to CREC office. All original signatures should be kept by the applicant. Applicant should upload all scanned signatures and study document to the HA CRER Portal. Please refer to “Submission Guidelines” for more details.
Note: All documents uploaded to the HA CRER Portal should be in PDF format.
Amendment Application
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.
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.
Note: All documents uploaded to the CREC Submission Portal (Post-approval Activities) should be in PDF format.
SAE and SUSAR Submission
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 (Local SAE Submission or SUSAR 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: The submission must be confirmed within 14 days
For SAE submission: Submissions can be initiated by either the PI or an authorized delegate and confirmed by PI or Co-investigator(s).
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.