The PHREB Accreditation applica
1. Letter of intent (please indicate Accreditation Level being applied for) addressed to:
Dr. Leonardo D. de Castro
Chair, PHREB
Attn Dr. Cecilia V. Tomas
Chair PHREB Sub Committee on Standards and Accreditation
2. PHREB Accreditation Forms:
For Level 2 (ERC to review clinical trials not intended for registration of new drugs (e.g. non industry trial by residents/fellows/ consultants)
PHREB Form 001 (Registration Form), Form 002 (Annual Report Form), Form 004 (Checklist Form), Form 005 (Assessment Form), and Form 006 (Protocol Summary for the last 3years)
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For Level 1 (ERC to review researches involving human participants except clinical trials)
PHREB Form 001 (Registration Form), Form 002 (Annual Report Form), Form and Form 006 (Protocol Summary for the last 3years)
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*you can download the forms here
3. ERC's SOP
4. FOR LEVEL 2 (only): three (3) Protocol files reviewed by the ERC, as indicated on PHREB form 006.
NOTE: Protocol files includes the protocol itself, communications to/from PI/ERC, minutes where the protocol were discussed, decision letter, etc.
NOTE: Protocol files includes the protocol itself, communications to/from PI/ERC, minutes where the protocol were discussed, decision letter, etc.
5. Copy of ERC members' CVs and certificate of ethics-related trainings
6. Proof (documents or picture as attachment) - if applicable
a. Picture of ERC office, equipment and files
b. Picture /hard copy of Institutional Organizational Chart showing the location of the ERC (under which institutional authority it is under)
c. Picture /hard copy of General Flow Chart of the ERC procedures from submission of protocol (start) until the ERC action (Approval, minor revision/modification, major revision/modification or disapproval
7. Php 3,000.00 Accreditation Processing Fee. *NOTE: if cheque, payable to PCHRD
Send first to PHREB the soft copy of all forms and requirements via email for assessment. PHREB will advise for the submission of 3 sets of hard copies of all the documents, together with the Accreditation Processing fee, once the soft copies are checked and completed.
Deadline for application (with submission of three (3) sets of hardcopy of the said documents and application payment to PHREB office, c/o PCHRD, DOST Compound, Gen. Santos Ave., Bicutan, Taguig City) is
n
ot later than
December 2015 (for Level 1
) Please refer on 'Updates on PHREB Accreditation handout (06 Mar 2015)' and '2014 PHREB Accreditation
