Frequently Asked Questions (FAQs)

  1. 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.
  2. 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.
  3. 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.
  4. When do we pay ethics review fee?
    • Upon submission of the protocol, otherwise, it will not be reviewed.
  5. 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