DR. PAULINO J.

GARCIA MEMORIAL
RESEARCH AND MEDICAL CENTER
R E S E A RC H D E V E LO P M E N T U N I T

P R OTO C O L R E V I E W P R O C E S S
Alexander A. Tiongson, MD, DPBO, FPAO, FPCS, MHM
Scientific Review Committee Chair

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 THE 3 LEVELS OF PROTOCOL REVIEW

TECHNICAL REVIEW
(Within investigator’s own unit
or department)

SCIENTIFIC REVIEW
(RDU)

ETHICS REVIEW
(IRB)

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 PRIMARY
TECHNICAL SCIENTIFIC
INVESTIGATOR REVIEW REVIEW
(UNIT/DEPARTMENT) (RDU)

Approved; for
2
3
Decision Endorse to RDU endorsement to
Decision
IRB

1 1
Disapproved Disapproved 3
2 For call for
With modifications presentation
ETHICS
PI is given IRB
forms to fill out REVIEW
(IRB)
PI invited to attend

PROTOCOL REVIEW
RDU monthly
scientific review
session

WORKFLOW Approved; for

2
Decision endorsement to
IRB

1
Disapproved 3
With modifications

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 DEPARTMENT RESEARCH COMMIT TEE
ORGANIZATION STRUCTURE ( S U G G E S T E D )

Department/Unit Head
Research
Coordinator

Technical reviewer Technical reviewer Technical reviewer

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 RESEARCH COORDINATOR’S
DUTIES AND RESPONSIBILITIES
• Plans and coordinates the initiation and completion of research study protocols of training
residents
• Promotes research capacity building in the department in coordination with RDU
• Supervises and coordinates the provision of scientific writing support and technical review to
investigators and researchers within the department
• Gives technical clearance and/or endorsement of study protocols in coordination with the
department’s technical review team to the scientific review committee (SRC) of the RDU
• Reports and coordinates with PETRO on completion of residents’ research paper as required per
year level

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 TECHNICAL REVIEW (DEPARTMENT LEVEL)

• The technical review is the first

level of review, conducted
within the PI’s own department
or unit
• The technical reviewer within
the department evaluates the
protocol and completely fills
out and signs the Department
Technical Review Form (right)

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 TECHNICAL REVIEW (DEPARTMENT LEVEL)

• All research protocols should have

the following:
• Project leader – the research
adviser/s who will guide the
principal investigator
• Co-project leader – the principal
investigator (I.e., the resident)
Please note that these “technical designations” are for
purposes of technical review only – ultimately, the
principal investigator (i.e., the resident or fellow) will still
serve as the main author of the research paper

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 TECHNICAL REVIEW (DEPARTMENT LEVEL)

• There are sections within the Department

Technical Review Form which require
consultation with a statistician
• During the drafting of the protocol, the PI is
expected to consult with a statistician and
secure a signed Statistician Consultation
Form from him PRIOR to submission to the
RDU
Please note that PIs may choose to consult freely
outsourced

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 TECHNICAL REVIEW (DEPARTMENT LEVEL)
• Once the department technical reviewer
finishes assessing the paper, he/she ticks the
appropriate box for the protocol’s
disposition
• The department technical reviewer and the
department research coordinator then sign
the form
• Once the protocol is suitable for submission
to the RDU, the PI secures two (2)
endorsement letters addressed to the RDU
chairperson:
• from the department research
coordinator
• from the department chairman / unit
head

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 SCIENTIFIC REVIEW (RDU LEVEL)
• The second level of protocol review
• Requirements:
• Four (4) hard copies of the following:
1. Research protocol
2. CV and GCP training certificates of at least 2 members of the research
team
3. Statistician consultation form
4. Completed and signed department technical review form
5. Endorsement letter from the department research coordinator
6. Endorsement letter from the department chairman/unit head
• Softcopies of the above documents, all in a single digital file, to be emailed
to Mr. Jude Francis A. Jumaquio (RDU research assistant) at
research.drpjgmrmc@gmail.com

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 SCHEDULED ACTIVITIES FOR RESEARCH
Type of Scientific Schedule of Release of
Eligible Protocols
Review Review Decision
All research studies which present more than minimal Within 10 working days after
Regular/ Full
risk to subjects RDU scientific review meeting
Protocols which may be considered are: Within 10 working days after
• those involving minimal risk to subjects receipt of research protocol
• those involving minor changes in previously
approved protocols
Expedited • those involving data analysis with no subject
interaction
• those that are part of a multicenter study which
have already been approved after a full review
from another ERC or IRB
Case report; Case series Not applicable; direct to IRB
(but IRB will still require
Exempted
technical clearance
from department)

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 SCIENTIFIC REVIEW (RDU LEVEL)
• Once all requirements are submitted to the RDU research assistant, the PI awaits
for the confirmation E-mail declaring official receipt/acceptance of the
submitted research protocol for RDU scientific review
• Monthly RDU scientific review meetings are held every 3rd Monday of the month
• Cut-off for acceptance for protocols is every 1st Monday of the month at 12
noon
• The RDU full scientific review decision is released within 10 working days after
the RDU scientific review meeting. RDU decision may be one of the following:
• For endorsement to the IRB for ethical clearance
• With modifications
• For call for presentation
• Disapproved

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 TECHNICAL REVIEW (DEPARTMENT LEVEL)
• For research protocols for revision (with
modifications), the PI will receive a Summary of
Comments and Compliance Form (right)
• The PI is given seven (7) working days to submit
his/her revised protocols for reassessment,
otherwise it will be considered new submission
and will be relegated to the next month’s batch of
protocols for review
• Requirements for submission for reassessment:
• Revised research protocol
• Filled-out Summary of Comments and
Compliance Form
ONCE REASSESSED AND APPROVED BY THE RDU,
THE PROTOCOL IS ENDORSED TO THE IRB FOR
ETHICAL CLEARANCE AND THE PI IS GIVEN IRB
FORMS TO FILL OUT

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 * Research topics are encouraged to be aligned to our 10-point Hospital Research Agenda

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 DOWNLOADABLE FORMS

https://tinyurl.com/RDUSRCFORMS

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DR. PAULINO J. GARCIA MEMORIAL
RESEARCH AND MEDICAL CENTER
R E S E A RC H D E V E LO P M E N T U N I T

P R OTO C O L R E V I E W P R O C E S S
Alexander A. Tiongson, MD, DPBO, FPAO, FPCS, MHM
Scientific Review Committee Chair

P E R F O R MRESEARCH
A N C E G O V E R NDEVELOPMENT
ANCE SYSTEM UNIT