FORMAT​ ​OF​ ​RESEARCH​ ​PROTOCOL​ ​

​
TITLE​ ​PAGE​ ​
Title​ ​
Authors/Investigators​ ​
Institution​ ​
Date​ ​and​ ​Place​ ​
​
​
I.​ ​ INTRODUCTION​ ​
A.​ ​ Background​​ ​–Briefly​ ​describe​ ​the​ ​disease​ ​or​ ​condition​ ​and​ ​why​ ​it​ ​is​ ​
important​ ​ ​
State​ ​reason​ ​why​ ​study​ ​being​ ​proposed​ ​,​ ​i.e.​ ​what​ ​are​ ​the​ ​problems,​ ​issues,​ ​
controversies,​ ​or​ ​uncertainties​ ​
​
B.​ Literature​ ​Review​​ ​–​ ​what​ ​other​ ​authors​ ​say​ ​or​ ​do​ ​not​ ​say;​ ​what​ ​other​ ​
studies​ ​say​ ​or​ ​do​ ​not​ ​say​ ​
​
C.​ ​ Significance​ ​of​ ​the​ ​study​ ​or​ ​Rationale​ ​of​ ​the​ ​study​ ​-​ ​what​ ​does​ ​this​ ​
paper​ ​attempts​ ​to​ ​answer​ ​
​
II.​ ​ RESEARCH​ ​QUESTION:​ ​ ​
PIOM:​ ​P​opulation,​ ​In​ tervention​ ​or​ ​diagnostic​ ​test,​ ​O​utcome,​ ​M​ethods​ ​
​
III.​ ​ OBJECTIVES​ ​
A.​ ​ General​ ​objective(s)​ ​-​ ​primary​ ​objective​ ​
B.​ ​ Specific​ ​Objectives​ ​
​
IV.​ ​ METHODS:​ ​
A.​ Study​ ​design​ ​ ​
1.​ ​ Randomized​ ​controlled​ ​trial​ ​
2.​ ​ Cohort​ ​study​ ​
3.​ ​ Case-control​ ​
4.​ ​ Cross-sectional​ ​ ​
5.​ ​ Survey​ ​
6.​ ​ ​Case​ ​series​ ​
7.​ ​ Diagnostic​ ​validity​ ​study​ ​ ​
​
B.​ ​ Study​ ​population​ ​(Who?)​​ ​–​ ​target​ ​population,​ ​manner​ ​of​ ​selection,​ ​
sample​ ​size​ ​
C.​ ​ Study​ ​Location​ ​or​ ​Setting​ ​(Where?)​​ ​–​ ​setting/institution​ ​
D.​ ​ Time​ ​frame​ ​(When?)​​ ​–​ ​when​ ​study​ ​will​ ​start,​ ​duration​ ​ ​
E.​ ​ Procedure​ ​or​ ​Intervention​ ​(What?)-​​ ​describe​ ​in​ ​detail​ ​
1.​ ​ If​ ​intervention​ ​-​ ​including​ ​dose,​ ​interval,​ ​duration​ ​
2.​ ​ If​ ​diagnostic​ ​procedure-​ ​describe​ ​how​ ​the​ ​test​ ​and​ ​how​ ​it​ ​will​ ​be​ ​
interpreted​ ​

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​
 FORMAT OF RESEARCH PROTOCOL

TITLE PAGE
Title
Authors/Investigators
Institution
Date and Place

I. INTRODUCTION
A. Background​ –Briefly describe the disease or condition and why it is
important
State reason why study being proposed , i.e. what are the problems, issues,
controversies, or uncertainties

B. Literature Review​ – what other authors say or do not say; what other
studies say or do not say

C. Significance of the study or Rationale of the study -​ what does this

II. RESEARCH QUESTION:

III. OBJECTIVES
A. General objective(s) - ​primary objective
B. Specific Objectives

IV. METHODS:
A. Study design
1. Randomized controlled trial
2. Cohort study
3. Case-control
4. Cross-sectional
5. Survey
6. Case series
7. Diagnostic validity study

B. Study population (Who?)​ – target population, manner of selection,

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 3. Sampling
Random sampling – non-purposive selection of participants
from a previously available list
4. For randomized controlled trails
a. Randomization – equal choice of being assigned to
treatment arm selected; method is unbiased and leads to
unpredictable sequences, e.g. computer-generated random
numbers, table of random numbers, drawing lots, coin toss
b. Allocation concealment - Process of allocation used will
prevent foreknowledge of the next assignment in the
sequence of group assignments by those recruiting participants
and the participants themselves, e.g. serially numbered identical
drug containers prepared by an independent pharmacy,
central randomization performed at a site remote from the trial
location, sequentially numbered opaque sealed envelopes,
on-site computer-based system with randomization that is not
readable until allocation; any other procedure where the
assignment schedule generated using true randomization is
administered by someone who is not responsible for
recruiting participants
c. Treatment blinding (Care provider and participant) –
procedure where those providing and receiving care do not
know the group to which the recipients of care will be
allocated; describe if drugs or drug containers are identical
in appearance
d. Outcome Assessor blinding – describe how the outcome
assessors for clinical or laboratory outcomes will not be able to
know the treatment regimen being given

F. Data Collection
Method
Data collection tool
Data collation and encoding

G. Analysis
Statistical test
Computer program used
Intention-to treat analysis – should fulfill BOTH criteria: (a) all
participants will be analyzed in the groups to which they were randomized
regardless of which and how much treatment they actually received and
regardless of other protocol irregularities, and; (b) all participants should
be included regardless of whether their outcomes were actually collected
or known

H. Ethical Issues – state that the study has been approved by the appropriate
ethical review board of the institution prior to conduct of the study; describe

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 how informed consent will be taken. Describe compliance with the National
Ethical Guidelines for Health and Health-Related Research 2017 and the
Data Privacy Act guidelines

V. LIMITATIONS OF THE STUDY

VI. REFERENCES

VII. APPENDIX
A. Sample tables and graphs
B. Informed consent form
C. Budget

LMGonzales
REV 07/07/2018