FORM 5.

1
STANDARD PROTOCOL TEMPLATE

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PROTOCOL TITLE

Principal Investigator:
(List PI’s name, degree, position, affiliation, address, telephone, e-mail)

Co-Investigators:
(List PI’s name, degree, position, affiliation, address, telephone, e-mail)

Research Officer/Adviser:
(List PI’s name, degree, position, affiliation, address, telephone, e-mail)

Study Site(s): (List all sites involved)

Protocol Version: (1.0)

Protocol Date: (month/day/year)

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TABLE OF CONTENTS

I. INTRODUCTION
Background of the Study
Significance of the Study
Objectives
General Objectives

Specific Objectives
Expected Outcomes
Target Beneficiaries
Study Duration

II. REVIEW OF RELATED LITERATURE

International studies
Local studies

III. METHODOLOGY
Study Design
Setting
Population and Sampling Method
Sample Size
Inclusion Criteria
Exclusion Criteria
Definition of Terms
Data Gathering Procedures
Statistical Analysis
Scope and Limitation
Ethical Considerations
Publication Plan
Research Utilization
Gantt chart
Study Budget

REFERENCES
APPENDICES

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 CHAPTER I
INTRODUCTION

Background of the Study

This section contains a brief summary of the background information relevant to the research
design and protocol methodology. Sufficient information includes description of disease/condition of
interest and present knowledge of the subject matter of the research. This information is necessary in
order to understand the rationale for the research.

This section is also based on your objective(s). How are the possible answers to the objective(s)
explained and defended? What are assumptions and relationships? What are the working hypotheses?
Justification of your conducting this study based on existing knowledge and your research question.
Describe the disease including incidence. Provide a summary of previous pre-clinical studies, relevant
clinical studies, or any epidemiological data if available include references with citations from the
literature. In the last paragraph state the main purpose of the study summarizing all the information
provided in your background section.

Conceptual Framework, if any

Significance of the Study

This is the rationale of the research. It answers the question, “what is the research for?”

Objectives

This section enumerates the goals that the program or project would attempt to achieve. If
possible, delineate the general from the specific objectives. Research objectives should be: Specific,
Measurable, Attainable, Relevant and Time-bound. If the proposal is a program, the program objectives
as well as specific project objectives should be indicated.

General Objective

(The general objective(s) must have scientific merit, provides some meaningful
information to help guide clinical practice, etc.) Preferably, the primary objective should address
a specific hypothesis. IF so, then state the hypotheses in quantifiable terms.

Specific Objectives

Secondary objectives may or may not be hypothesis-driven, may include secondary

outcomes, and general non-experimental objectives (e.g. to develop a registry, to collect natural
history data).

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Expected Outcomes
 This refers to the end results (e.g., production technology or knowledge) expected upon
completion of the research. The output(s) needs to be identified to highlight impact/importance of the
research.

Target Beneficiaries

This refers to the probable end-users or beneficiaries of the research output and the number and
locality of beneficiaries, if applicable.

Study Duration

This refers to the planned start date, completion date, and duration in months.

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CHAPTER II
REVIEW OF RELATED LITERATURE

This section should discuss literatures relevant and specific to the topic of the research proposal.
It should be complete enough so the reader can be convinced that the research proposal being presented
is built upon sound information base, addresses current country health priorities and will contribute
something new to health and/or allied health sciences.

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CHAPTER III
METHODOLOGY

Study Design

This section indicates how the research objectives will be achieved. It includes a description of
the type of research design (e.g., cross sectional, case control, cohort, etc.)Briefly describe the study
design and indicate, in general terms, how the design will fulfill the intent of the study.

Setting
 This section details the location, station, or unit where research will be conducted.

Population and Sampling Method

This is required for studies involving animals and humans. This section states the number of
research participants required to enter and complete the research. A brief definition of the type of
research participant required is also described.

Sample Size

This section describes the type of sampling design and the assumptions used to compute the
sample size.

Inclusion Criteria (enumerated in bullets)

This section describes the criteria each research participant must satisfy to enter the research. These
criteria may include, but are not limited to the following: age, sex, race, diagnosis or condition, method
of diagnosis, and diagnostic test.

 List the disease or disorder under study

 How will it be documented, i.e. diagnostic methods, criteria for classification, etc.

 Demographic characteristics (e.g., gender, age) as applicable

Exclusion Criteria (enumerated in bullets)

This section details the criteria that would eliminate a participant from participation in the
research.
 List specific clinical contraindications.
 Specify any specific grades of signs/symptoms.

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Risk and Benefits Assessment

As appropriate, address the following parameters as each relates to the individual subject in the
study. Be sure to include consideration of study assignment (Arm A, Arm B, placebo, active substance,
etc.)
1. Physical risks
2. Psychological risks
3. Social risks
4. Economic risks
5. Potential benefit of participating in the study
a. to the individual subject and/or parent
b. to the population from which the subject is drawn
c. to science, society, and humanity in general
Operational Definition of Terms

Clear-cut meaning of the terms used. This detailed description of each term is designed to ensure
that each term is interpreted the same way by different people. They are key to insuring the integrity of
any terminology system.

Data Gathering Procedures

This section explains the plan of action, procedures and methods to be used during the research.
Detailed methodology is described for laboratory, diagnostic, interviews, and manner of data collection.
Special instrumentation may be described in a subsection (instrumentation or data collection tools,
special equipment, etc.)

Statistical Analysis

Computer facilities to be used, software packages

Statistical tools or tests to be used [Measures (i.e., response (measure of interest) explanatory
(factor potentially associated with measure of interest), other (demographics etc.)]
Primary measure (including definition, data type and range of values)
Secondary measure(s)
Dummy tables

Scope and Limitation

Defines exactly what will be covered in a study, while the limitations are the constraining aspects
that may have influenced or affected the research.

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Ethical Considerations

Institutional Ethics Review Board (IERB)

This protocol, and any subsequent modifications, will be reviewed and approved by EAMC
IERB. We request a Waiver of Informed Consent due to the retrospective nature of this
research. [remove this statement if not applicable]

Subject Privacy and Confidentiality

All records will be kept in a locked file cabinet. Human subject’s names will be kept on a
password protected database and will be linked only with a study identification number for
this research. There are no patient identifiers. All computer entry and networking programs
will be done using study identification only. All data will be entered into a computer that is
password protected. Clinical information will not be released without written permission of
the subject, except as necessary for monitoring by IRB, the Sponsor, or the Sponsor’s
 designee. Data will be stored in a locked office of the investigators and maintained for a
minimum of three years after the completion of the study. Some institutions have different time
frame for the storage of data. Check institutional SOPs.

Publication Plan

Describe plans for publication of research results. List any meetings or conferences where you
will be presenting the data and the results of your study. Please provide timeline for finalizing
manuscript and when and where you plan to submit for publication. Any presentation, abstract, or
manuscript will be reviewed by the Research Committee of each Department.

Research Utilization

This section should indicate the strategies to be used in disseminating and ensuring utilization of
the expected research results. For product-based research, proposal should include the prospective
technology user, as well as, plans for technology transfer.

Gantt Chart

This is brief description in chronological order of each activity to be undertaken. The plan of
work of a project should reflect the schedule of the study components. For the program, individual
schedules of each of the projects should be supplied. A Gantt chart of activities should be given. This
chart will indicate the relative time frame and schedule of the major activities of the proposal, including
plans for research utilization.

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Briefly state the stages of your study for example,

Stage 1, review of medical records ----4-6 months
Stage 2, data collection and data analysis
Stage 3, presentation and publication…
Include a projected start date.
Provide the total length of time and include an approximate end date of the study.
It is convenient for the reviewer to see the events of the study schedule or duration in the form of
a flow chart.

Study Budget

Indicate the annual budget of the proposal according to source of funds. For the first year,
specify the budget for major expense items. For succeeding years, only the total annual budget is
required initially. The detailed breakdown of financial assistance requested should be in accordance with
the New Government Accounting System (NGAS); the counterpart funding of the implementing agency as
well as other agencies cooperating in the project should also be reflected. Details of the financial
requirements per expense item and source of funds are illustrated at the end page.
 Under the Personnel Services (PS), segregate the number and positions of those who will be
receiving salaries from those who will be entitled to honoraria. Salaried personnel will consist of those
who will work full time for the project.
Part-time staff to be hired for the research will be entitled to honoraria. Likewise, the Project Leader and
the consultants will be recipients of honoraria. Indicate the recommended salaries/honoraria rates per
position and the coverage of their service periods.

For Maintenance and Other Operating Expenses (MOOE), the traveling expenses of
transportation of one’s personal and essential baggage, per diems while in route or away from
permanent station and items necessarily incidental thereto in connections with the research work. The
item on supplies and materials will include expenses on consumable and semi-expendable
field/laboratory/office supplies and materials needed in the course of the research. Budget for sundry will
consist of expenses on communications, repairs and maintenance, estimated cost for research utilization
(RU) component, computerization, and miscellaneous expenses. Details for each line item should be
provided.

The Capital Outlay (CO) details the budgetary requirement of the research for equipment items
needed for the project. Indicate the quantity, unit cost and total amount.

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REFERENCES

An alphabetical, numerical list referencing or of source of relevant information or literature as used in

referred medical journals or other international journals, should be followed. [This section must always
be in a separate page]
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APPENDICES

Curriculum Vitae

This portion provides relevant information regarding the proponent’s research capability. Must
be signed and dated.

Data Collection Forms, if any

Such as Survey Questionnaires, Interview questions, etc.

Informed Consent forms/Assent

Should follow the EAMC IERB templates and always in English and Tagalog versions.