Research Ethics Review Board
Frequently Asked Questions
The CGHMC RERB meets via Zoom or face-to face every 3RD or 4TH Thursday of the month and releases its approval/query letter 1 week after the said RERB meeting. Turnaround time from submission to approval is usually around 2 to 3 months.
(amendment, continuing review, protocol deviation, early termination, final report, SAE, notification)
For Initial and post-approval review of industry-sponsored and investigator initiated protocols submitted on or before the 1st week of the month will be included in the same month’s RERB meeting
The electronic copy of the protocol package for review and approval should be submitted on or before the submission cut-off date which is every 15th of the month. Three (3) hard copies should be submitted within the week after the electronic submission.
No, but PI may be called to join the meeting for a clarificatory interview to answer and clarify questions raised by the Board.
The validity of the ethical approval is for one (1) year only, hence, the Principal Investigator should submit progress report and apply for a Continuing Review.
Upon submission of the protocol.
The Sponsor prepares the tri-partite clinical trial agreement to be signed by the Sponsor, Principal Investigator and Chinese General Hospital and Medical Center (CGHMC). CGHMC signatory is SAMUEL ANG, M.D., Medical Director. The RERB is NOT a signatory of the CTA. The CTA undergoes RERB endorsement and legal review prior to the approval of the Medical Director.