New Application

The Joint CUHK-NTEC CREC’s initial review and a written approval is a mandatory requirement prior to initiation of any clinical study under the Joint CUHK-NTEC CREC’s jurisdiction. Principal investigators are required to observe the review meeting schedule and application submission deadlines announced by the Joint CUHK-NTEC CREC from time to time for the purpose of time planning, and shall comply with the Joint CUHK-NTEC CREC’s requirements in compiling and submitting the applications.

Submission of New Applications

Online Application with all documents uploaded via the Portal is required. One set of original hardcopy of all the documents must also be submitted to the Joint CUHK-NTEC CREC.

Submission of 1 set of hardcopy (original) of the documents in the following order:

Documents Required for an Application for Initial Review

Document		Language		Submission Format
Document		Eng	Chi	Hardcopy	Portal
1.	Submission Letter for Initial Review
2.	Clinical Study Categorization Form
3.	Clinical Research Ethics Review Application Form
4.	Supplementary Information Sheet for Phase 1 Study
5.	Principal Investigator’s and Co-Investigator(s)’ Curricula Vitae
6.	Principal Investigator’s and Co-Investigator(s)’ Conflicts of Interest Declaration Forms
7.	Indemnity Agreement
8.	Certificate of Insurance (for clinical studies)
9.	Study Protocol
10.	Investigator’s Brochure
11.	Informed Consent Form and/or Subject Information Sheet
12.	Subject Recruitment Materials (e.g. Subject Recruitment Advertisement or Poster)
13.	Documents/materials for Use by Subjects in the Study (e.g. Subject-administered Questionnaire(s) or Diary(ies))
14.	Crossed Cheque/Bank Draft for Payment of Initial Review Application Fee

= mandatory = required if applicable

It is the Principal Investigator’s responsibility to ensure that hardcopy documents are consistent with the Online Application submitted. In case of any discrepancy between the online and hardcopy versions of the submitted documents, the hard copy version shall prevail.

Please kindly note that if the new research ethics study has a plan to apply for clinical trial approval from the National Medical Products Administration (NMPA) in the People’s Republic of China, all applicants are required to inform the Joint CUHK-NTEC CREC by replying the acknowledgement email. If CUHK-NTEC CREC didn’t get your response, the application will be regarded as a non-NMPA study.

Categorization of Clinical Studies and Assignment of Review Channels

Principles of Study Categorization

To enhance the efficiency and effectiveness of initial reviews, the Joint CUHK-NTEC CREC adopts a risk categorization approach by categorizing clinical studies based on six groups of risk factors including:

Involvement of human subject recruitment
Subject vulnerability
Subject assignment methods
Involvement of medical products
Involvement of clinical procedures
Study designs

Mechanism for Study Categorization and Review Channels

The detailed mechanism for categorization of clinical studies is set out on the “Clinical Study Categorization Form”. Principal investigators are required to complete and submit the form together with each application for initial review. Upon receipt of an application, the Joint CUHK-NTEC CREC will verify the information on the form and arrange for initial review through one of the following review channels:

Channel A : Full Review by the Standard Panel
Channel B : Expedited Review by the Expedited Panel
Channel C : Full Review by the Phase 1 Panel (Recommend the Principal Investigator to collaborate with a study site under the Jurisdiction of a Research Ethics Committee with a specific review panel for Phase 1 Clinical Trials)

Chairman’s Authority to Assign Review Channel

Notwithstanding the result of categorization under the aforesaid mechanism, the Joint CUHK-NTEC CREC shall have the authority to:

Re-assign an application for expedited review if the study is a multicentre study which has already been approved by any research ethics committee under the HA, and no substantial difference is anticipated with respect to protection of the rights, safety and well-being of subjects whether the study is conducted by the applying principal investigator or by another approved principal investigator; or
Re-assign an application for review through any of the other channels at reasonable discretion.