Frequently Asked Questions (FAQs)
- How long does it take for MMERC to approve a protocol?
- The MMERC approves a reviewed and deliberated protocol after the ERC meeting date set every second Wednesday of the month, or otherwise declared, and releases its approval/query letter 1 to 5 days after the said ERC meeting. Turn around time from submission to approval is usually 1 to 2 months.
- How many copies of the protocol should I submit?
- 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 30th of the month. One (1) soft copy should be submitted and (4) hard copies within the week after the electronic submission.
- How long is the validity of the ethical clearance?
- The validity of the ethical approval is for one (1) year only, hence, the Principal Investigator should apply for a Continuing Review.
- When do we pay ethics review fee?
- Upon submission of the protocol, otherwise, it will not be reviewed.
- Who prepares the CTA?
- The Sponsor prepares the tri-partite clinical trial agreement to be signed by the Sponsor, Principal Investigator and Medical Center Manila, Inc.
- MCM signatories are: VICENTE D.R. BERNARDO III, M.D. (Medical Director) and EDUARDO S. ESEQUE, M.D. (President).
The MMERC is NOT a signatory of the CTA. The CTA undergoes ERC endorsement prior to approval of the Hospital Director and President