If the protocol is classified as full review and there are no further modifications, approval may be issued at least four weeks after receipt of the initial submission. Turnaround time is usually around two to three months. If the protocol is classified as expedited review and no further modifications to it, the approval may be issued at least two to three weeks after receipt of submission.
The CSMC RERC meets via Zoom every 4th Wednesday of the month except December or otherwise declared.
When is the cut-off of submission for initial review and post-approval review? (amendment, continuing review, protocol deviation, early termination, final report, SAE, notification)
Initial review for industry-sponsored protocols: 1st Wednesday of the monthInitial review for investigator-initiated protocols: 2nd Wednesday of the monthPost-approval reports ((amendment, continuing review, protocol deviation, early termination, final report, SAE, notifications): 1st Wednesday of the month
Investigator-initiated protocols- three (3) complete sets of hardcopy and electronic copy.Industry-sponsored protocols – Four (4) complete sets of hardcopy and electronic copy.The electronic copy of the protocol package for review should be emailed to firstname.lastname@example.org on or before the submission cut-off date. Complete set of hard copy should be submitted within the week after the electronic submission.Post-approval reports ((amendment, continuing review, protocol deviation, early termination, final report, SAE, notifications)– 2 hard copies and electronic copy
The validity of the ethical approval is for one (1) year only, hence, the Principal Investigator should apply for a Continuing Review.
Storage of clinical trial drugs and other expenses are not included in the review fee. There should be a separate agreement with the CSMC Pharmacy for storage.
Upon submission of the protocol.
The Sponsor prepares the tri-partite clinical trial agreement to be signed by the Sponsor, Principal Investigator and Cardinal Santos Medical Center. CSMC signatory is ZENAIDA JAVIER-UY, MD- Senior Vice President and Chief Medical Officer.The RERC is NOT a signatory of the CTA. The CTA undergoes RERC endorsement prior to the approval of the Chief Medical Director.
Non-CSMC investigator must have a co-investigator or consultant or adviser who is affiliated in CSMC.
No, but PI may be advised to join the meeting for a clarificatory interview to answer questions raised by the Board and to shorten the duration of the review.
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