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PHREB Form 001

Application Form for


Registration and Accreditation
Ver. 002 | Rev. 11 Feb 2015

APPLICATION FORM FOR REGISTRATION AND ACCREDITATION


A. Information about the Ethics Review Committee (ERC)
Name of Ethics Review
Committee:
Name
of
Institution:
Address:
(No.,
Street,
Town/City,
Province, Region)
Contact
Positio
Person:
n:
Telephone:

Mobile:

Fax:

Email
address:

Date and Year Ethics


Review Committee was
established:
Frequency
of
Ethics
Review
Committee
meetings:

[ ] Once a month
[ ] Once every 2
months
[ ] Once every 3
months

[
] Once every 6
months
[ ] Once a year
[ ] As needed

B. Category of ERC According to PHREB Accreditation Procedures as of


February 2014
[
Academic Institution-based RERC (AI-RERC)
]
[
Hospital-based RERC (H-RERC)
]
[
Government-based RERC (G-RERC)
]
[
Consortia for regional health and development RERC
]
(CHRD RERC)
[
Cluster RECs (C-RERCs)
]
[
Research Site-based RERCs (R-RERCs)
]
[
Other RERCs not covered by the above categories
]
(Please state)
____________________________________________________
C. Composition of Ethics Review Committee
Number
of
Members:
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PHREB Form 001


Application Form for
Registration and Accreditation
Ver. 002 | Rev. 11 Feb 2015

NAME

PROFESSION/
SPECIALTY/
OCCUPATION

Sex

M F

Affiliate
d with
the
Instituti
on
YE NO
S

Ethics Training

Affiliate
d with
the
Instituti
on
YE NO
S

Ethics Training

YES,
Please
indicate
(Basic,
GCP, SOP)

N
O

Chair:
Vice-Chair:
Secretary:
NAME

PROFESSION/
SPECIALTY/
OCCUPATION

Sex

M F

YES,
please
indicate
(Basic,
GCP, SOP)

N
O

Members:

*Add more rows if needed


D. Types of Researches Reviewed
(*Please attach PHREB Form 006 Protocol Summary)
Number of Protocols
Type of research
Reviewed
(past 3 years)
Year 1
Year 2
Year 3
20___
20___
20___
Clinical Trials (sponsor-initiated)
- Phase 1
- Phase 2
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PHREB Form 001


Application Form for
Registration and Accreditation
Ver. 002 | Rev. 11 Feb 2015

- Phase 3
- Phase 4
Clinical Trials (researcher-initiated)
Biomedical studies include Retrospective,
Prospective and Diagnostic Studies, and
use of human material and data
Health Operations Research includes
studies on Health Programs and Policies
Social Research includes KAPs of
communities, behavioral research, impact
of Public Health interventions
Public Health Research includes
epidemiologic researches (prevalence,
surveys, incidence)
Others (Please specify)
TOTAL NO. OF PROTOCOLS REVIEWED

E. Manual of Standard Operating Procedures


Does the ERC have a written Manual
Procedures? YES [ ] NO [ ]
List of ERC Standard Operating
available):
[ a. Constitution of the ERC and
]
staf and functions
[ b. Full review and expedited
]
review
[ c. Management
of
Initial
]
Submissions
[ d. Management of Post-approval
]
submissions
[ e. Preparation for and conduct of
]
regular meetings
[ f. Communication
with
]
researchers

of Standard Operating

Procedures (please check if


[
]
[
]
[
]
[
]
[
]

g. Management of Files
h. Site visits
i. Management of queries and
complaints
j. Writing and Revising of
SOPs
k. Others (please specify)

F. Level of ERC Accreditation


Please
check:

[ ] Level 1

[ ] Level
2

[ ] Level
3

Submitted
by:
________________________________
Signature over Printed Name
Noted by:

Date of
Applicati
on:

______________
MM/DD/YYYY

Date:

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PHREB Form 001


Application Form for
Registration and Accreditation
Ver. 002 | Rev. 11 Feb 2015

________________________________
Signature over Printed Name of
ERC Chair
Endorsed
by:

______________
MM/DD/YYYY
Date:

________________________________
Signature over Printed Name
of Head of Institution

______________
MM/DD/YYYY

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