How to develop a

research protocol

Dr.Shaik Shaffi Ahamed

Associate Professor
Department of Family & Community Medicine
Session Objectives
 Able to understand the different
components of a Research protocol
 Able to write a protocol on any

research topic of interest.

Protocol writing
Why a protocol?
 To clarify the research question
 To compile existing knowledge
 To formulate a hypothesis and objectives
 To decide about a study design
 To clarify ethical considerations
 To apply for funding
 To have a guideline and tool for the
research team
How to judge a good
protocol?
 Is it adequate to answer the research
question(s), and achieve the study objective?
 Is it feasible in the particular set-up for the
study?
 Does it provide enough detail (methodology)
that can allow another investigator to do the
study and arrive at comparable conclusions?
Basic content of the protocol
The content of research protocols might vary
according the content and context of the study
 Principal components:

Introduction/rationale of the study

Objectives/hypotheses
Methodology
Plan of analysis
Timeline
Ethical considerations
Budget
Bibliography
Title of a research project
 Accurate, short, concise
 Descriptive: should make the main objective
clear, should mention the target population
 Key words: should contain key words for
referencing
 i.e.
„TB in HIV – infected children“
 Better: „Incidence of TB in HIV- infected children in
USA during 2010-2013“
Project summary
 Concise, one page (about 300 words)
 Stands on its own – no reference to
protocol content
 Summarizes central elements (rationale,
methodology, populations, time frame,
expected outcomes)
Introduction
(i)Statement of the problem
 Why …is the research needed?
 What …is the relevance of the results?

Logical flow of statements:

Magnitude, frequency, and distribution: Affected geographical areas

and population groups. Ethnic and gender considerations.
Probable causes of the problem: What is the current knowledge of the
problem and its causes? Is there consensus? Is there controversy?
Is there conclusive evidence?
Possible solutions: In what ways have solutions to the problem been
attempted? What has been proposed? What are the results?
Unanswered questions: What remains to be answered? What areas
have not been possible to understand, determine, verify, or test?
(ii) Literature review

• Prevents duplication of work, which has been done

• Clarifies, what others have found addressing the
problem
• Familiarizes with potential methodologies and
methodological errors
• Should convince, that the research is needed!
(iii) Justification of research
Should be a convincing statement for the need to do
this research
 How does the research relate to the priorities of
the region and the country?
 What knowledge and information will be
obtained?
 What is the ultimate purpose that the knowledge
obtained from the study will serve?
 How will the results be disseminated?
 How will the results be used, and who will be the
beneficiaries?
Research objectives
Define a GENERAL OBJECTIVE and derive SPECIFIC
OBJECTIVES

The formulation of objectives will help to:

 Focus the study (narrowing it down to essentials)
 Avoid the collection of data which are not strictly
necessary for understanding and solving the
problem you have identified
 Organize the study in clearly defined parts or
phases
Research objectives
Objectives should be:
 Logical and coherent
 Feasible
 Realistic, considering local conditions
 Defined in operational terms that can be
measured
 Phrased to clearly meet the purpose of the study
(relevant)
Objectives should be stated in action verbes that illustrate their purpose:
i.e. “To determine…, To compare..., To verify..., To calculate...,To reduce..., To describe...,
etc.
Research hypothesis
Intervention,
Independent Dependent
Observation, Control
variable variable
variable

 Describes the relationship between INDEPENDENT

variables (risk factors, predisposing factors) and
DEPENDENT variables (outcome)
 Determines the type of data to be collected and the
type of analysis to be conducted
Specific objectives and Hypotheses

 List the specific objectives & hypotheses one by one concisely

 Not too many ; 2-4 best

 Be specific, no general and ambiguous statements

 Be realistic, no unachievable objectives

 Objectives & hypotheses should be logically linked and arranged in

a sequence
When you divide a section into subsections,
all the pieces should be of the same pie
Methodology
Important aspect of the protocol
 Assures, that the hypothesis will be proved or
disproved, using the right tools
 Presents a detailed strategy, how the objectives
are achieved
Consider
• operational definitions
• study design
• definition of variables
• sample size
• ethical aspects
Methodology
Study design
• The decision on study design needs to be based on
ethics, logistic consideration, economic aspects and
scientific thoroughness.

• The validity of the results including potential bias and

confounding and the generalizability of the results
needs to be a prime concern defining the study
design.
Methodology
Study design

Interventional study Observational study

Clinical trial Cohort study
Cross-sectional study
Case – control study
Ecological study
Methodology
Definition of variables
Methodology
Measurement of observations
 Describe how, when and where the observations
are made? Describe instruments used!
 Questionaire (attach to the protocol)
 Type of interview (describe structure of the interview)
 Laboratory test (refer to literature or personal
knowledge, if established test, or describe in detail, if
not established)
 Clinical examinations (describe gadget/procedure)
Describe all instruments or refer to literature if tools are established.
Methodology
Subjects/ participants

Depending on the type of study, answer the following

questions:
•What are the criteria for inclusion or selection?
•What are the criteria for exclusion?
•In intervention studies, how
will subjects be allocated to
index and comparison groups (Randomization
procedure)?
•What are the criteria for discontinuation?
Methodology
Data quality control
 Describe measures of data quality control:
 Double data entry
 Consistancy checking
 Data monitor
 Verfication procedures of source data
Methodology
Sample size
 Sample size calculation is recommeded
for economical and ethical reasons
 Level of error, power and expected impact
of exposure on outcome have to be set
Ethical considerations
One of the most important aspects of biomedical
research!
Important aspects to consider:
 Data safety / confidentiality
 Any possibly harm/ side effects/ consequences
 Right of discontinuation at any time
 Role of data safety and monitoring board (in trials)
 Alternative treatments/ approaches (in trials)
 Incentives/ Rewards
Ethical considerations
Informed consent
Outline how, when and where the patient will be
consented!
Information form should contain:
 Justification for research
 Responsibilities (Who)
 Outline of study
 Risks
 Confidentiality
Data management and
analysis
Based on objectives consider:
 Coding for variables/ type of variables
 Analysis plan depending on type of
variables
 Statistical tests implicated
 (Style of presentation i.e. tables, graphs)
 Data safety and storage
References/Bibliography
 Use of standard referencing system:
 Harvard style
 Name and publication year in text
 Alphabetical bibliography
 Vancouver style
 Numbered references
 Continous referencing in text
 Make use of software
 Reference Manager
 Endnote software
Work plan

Who?
Tasks When?
Where?
Budget
The budget should be broken down by:
 Items
 Personnel
 Consumables, equipment, supplies,
communication, funds for patients, data
processing
 Budget justification
 Jusitify
the use of each item, considering the
workplan of the study
Annexes
 Case Record Forms (CRFs)
 Questionaires
 Patient information form (in required
languages)
 Consent form (in required languages)
 CV of investigators
Common mistakes
 including too little detail about proposed
studies and insufficient justification for the
significance of the problem
 proposing far more work than can be
reasonably done during the grant period
 Writing Stages

1.
1.Getting
Gettingin
inthe
theMood
Mood 2.
2.Writing
Writingthe
theFirst
FirstDraft
Draft

Save multiple copies

of your draft

3. 4.
4.Finishing
3.Revising,
Revising,Revising,
Revising,Revising
Revising Finishing
Thank you