Documentos de Académico
Documentos de Profesional
Documentos de Cultura
March 4, 2015
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Level
1. Functionality of the structure & membership of the ERC
2. Adequacy of the Standard Operating Procedures and
consistency in its implementation.
3. Adherence to international, national and institutional
guidelines and policies.
4. Completeness of the review process
5. Adequacy of the after-review procedures
6. Adequacy of administrative support for ERC activities
7. Efficient and systematic recording and archiving
Features
Level 1
Level 2
Qualifies an ERC to review clinical trials
not intended for registration of new drugs
(e.g. non industry trial by
residents/fellows/ consultants)
Level
Features
Level 3
Review EC SOPs
Interview EC Representatives
Review Protocol Files, Meeting Agenda/Minutes
& Communication Records
Review EC SAE, Site Visit, Annual & Final Reports
Name of Institution
Expiry Date
31 July 2015
13-003
01 March 2013
29 February 2016
13-004
01 March 2013
29 February 2016
Accreditation
No.
L3-2014-001-01
Effectivity Date
Expiry Date
14 March 2014
14 March 2017
L3-2014-002-01
14 March 2014
14 March 2017
L3-2014-003-02
14 March 2014
14 March 2017
L3-2014-004-01
14 March 2014
14 March 2017
Accreditation No.
Effectivity Date
Expiry Date
L3-2014-005-01
14 March 2014
14 March 2017
L3-2014-006-01
25 Nov. 2014
25 Nov. 2017
L3-2014-007-01
25 Nov. 2014
25 Nov. 2017
L3-2014-008-01
25 Nov. 2014
25 Nov. 2017
L3-2014-009-01
25 Nov. 2014
25 Nov. 2017
Accreditation No.
Effectivity Date
Expiry Date
L3-2014-010-01
25 Nov. 2014
25 Nov. 2017
L3-2014-011-01
25 Nov. 2014
25 Nov. 2017
L3-2014-012-01
25 Nov. 2014
25 Nov. 2017
Accreditation No.
Effectivity Date
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L3-2014-013-01
Name of Institution
Accreditation No. Effectivity Date
Expiry Date
1. Our Lady of Fatima
L2-2014-001-01
25 Nov. 2014
25 Nov. 2017
University Institutional
Ethics Review Committee
L3-2014-014-01
L3-2014-015-01
L3-2014-016-01
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L2-2014-002-01
25 Nov. 2014
25 Nov. 2017
25 Nov. 2014
25 Nov. 2017
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30 April 2015.
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Only those which comply and will qualify will be processed in 2015. If ERC is
accredited before December 30, 2015, they continue reviewing new CTs. Awarding of
certificate: March 2016.
Applicant ERCs if still being processed, can continue to review Clinical Trials till the
end of December 30 2015. If accreditation process is not completed by January 01
2016, ERCs shall stop accepting new CTs (for FDA registration) but continue to
monitor previously approved CTs.
ERCs which apply but do not qualify for Level 3 can no longer accept clinical trials for
review after April 30 and they can apply again for Level 3 in 2016. They should apply
for Level 1 or 2 before December 30, 2015.
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Qualified ERCs
have to apply for
Level 3
accreditation by
April 30 , 2015
Qualified ERCs
have to apply for
Level 3
accreditation by
April 30 , 2015
Awarding of
accreditation certificate
in March or August
If accreditation requirements
are satisfied (including
approval/implementation of
action plan), ERC can accept
new CTs in 2016.
Monitoring of approved
protocols shall be
continued by the ERC
until completion
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plan within
30 days and report its implementation. When these are complied with, PHREB
will issue certificate of accreditation.
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Monitoring of previously
approved protocols shall
be continued till
completion
ERC continues to
accept new protocols
until expiry of
accreditation
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SSA approves
& awards Level
1 or Level 2
accreditation
ERC can continue
to accept new
protocols until
December 30, 2015
ERC submits
report on
implementation
SSA assesses
implementation of
ERC action plan
Monitoring of previously
approved protocols shall
be continued till
completion
Summary:
1. PHREB Requirements for Registration and Accreditation of RERCs (Feb. 2 2014)
1.1 PHREB Criteria for Accreditation - 7 standards
1.2 Accreditation Levels 1, 2, 3
1.3 Kinds of existing ERCs at present time
2. List of Accredited ERCs - Level 3 (19), Level 2 (3)
3. PHREB Memo to ERCs February 27, 2015 - application deadline (April 30, 2015) for
Level 3 ERCs. Level 1 and 2 applications are on-going till December 30 2015
4. Procedures to follow for Level 1,2 and 3 ERCs
Reference: PHREB Requirements for Registration and Accreditation of RERCs
(Feb. 2 2014) - Please review document for complete information.
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