Preparation of Article based on the Study Protocol - Pubrica
                     PREPARATION OF  
ARTICLE BASED 
ON  THE STUDY  
PROTOCOL
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, 
Pubrica  Group:www.pubrica.com
Email: [email protected]
TODAY'S  
DISCUSSI
ON
In brief  
Introduction
Components of a research protocol 
 Writing the protocol
Conclusion
IN 
BRA pIroEtocFol is a document that arranges out the
research strategy for a clinical study.
For all elements of clinical research, it is the  
single most critical quality control instrument.
This is especially true in multi-centre clinical
 research, which necessitates numerous  
investigators and their staff from many  
institutions in the study operations.
Contd...
Some protocol variations are insignificant, but  
others can affect the research's validity.
For example, a patient may be unaware of a  
condition that is present in its early or latent  
stage, or a patient may intentionally mislead a  
researcher into believing they will receive  
special treatment by participating in a study  
both of these scenarios result in violations of  
the research protocol's patient exclusion  
criteria.
INTRODUCTIO
N
 Clinical research is carried out following a set of guidelines (protocol) or an action plan.
The protocol arranges out the procedures for carrying out the trial.
It demonstrates what will be done in the study by describing each important component and 
 how it will be carried out.
It also explains the participants' eligibility, the study duration, the medications used, and the  
tests performed.
Contd...
A chief researcher is in charge of a protocol. Members of the research team will  
monitor the participants' health regularly to ensure the study's safety and  
effectiveness.
The journal considers protocols for existing or proposed large-scale, prospective  
research relevant to public health and public health management activities.
Suggestions should include a thorough description of the study's hypothesis,  
rationale, and methodology
Contd...
Table: 1 the key aims and benefits of the 
protocol
Correctly drafting the protocol will raise the possibility that the research's conclusions 
 are scientifically sound.
Colleagues and experts should be consulted for advice and recommendations
as  researchers build their plans.
The protocol should not be changed during the study or trials once it has begun.
COMPONENTS 
AO FRESEARCH 
PRTheO ClinTicaOl triaCls OmusLt be approved and managed by an  
Institutional Review Board, verifying that the risks are  
insignificant and that the benefits outweigh the risks.
It is an independent body made up of doctors, dentists,  
statisticians, and community members.
The committee guarantees that clinical trials are  
conducted ethically and that all participants' rights are  
respected.
The board must first approve the research and then  
examine it regularly
Table: 2 components of the 
protocol
WRITING 
TPHREOTOCO
L P rotocol writing enables the researcher to analyze  
and critically analyze published material on the  
research topic of interest, organize and review  
project processes, and serve as a guide during the  
study.
The proposal is an essential document that allows  
the researcher to track the project's progress
Contd...

1) Title of the Study: The proposal's title should be precise, brief, simple, and distinct.
What is the purpose of the study, and who are the participants? What is the study's  
setting, and, if appropriate, when will it be launched?
It should state the key goal, express the research's principal purpose, and identify the 
 target population.
In a few words, convey as much information about the issue as possible; it's a good  
idea to keep the title to 12-15 words.
It should express a concise, relevant, correct, appealing, easy-to-understand,
and  enlightening notion about the study area and the methodologies that will 
be applied.
Contd...
2) Administrative Details: Following the title page, the following administrative details and 
 a protocol content summary should be included:
A list of important sections and sub-sections with page numbers can be found on the  
contents page.
The signature page is signed and dated by senior members of the research team to  
confirm that the version in question has been accepted.
Members of the study team's contact information, including postal and e-
mail  addresses and phone numbers.
Contd...
3)Project Summary: The summary should be unique, concise, and cover all of the
protocol's essentials.
4)Introduction (Background): The project's background should be brief and direct in its 
 approach to the issue.
The strengths, disadvantages, and limitations of the studies cited should be highlighted  
in the review.
The introduction ends with an explanation of how the current study will benefit
the  community.
Contd...
The  literaturereviewservice should logically lead to a declaration of the
proposed  project's goals and end with the study's goals and objectives.
The review should contain the most recent papers on the subject.
The study topic is chosen only after the literature evaluation has been completed and  
identified gaps.
5) Study Objectives (Aims): The study questions/hypotheses lead to the study goals or 
 objectives.
Contd...
They are reactions to the possible replies to the research topic or hypothesis being  
investigated and measured.
Aims should be logical and cohesive, feasible, concise, and practical, considering  
local conditions and phrasing to satisfy the study's purpose and be related to the  
specific research's goals.
The purposes should be (SMART objective): Specific, Measurable, Achievable, Relevant  
and Time-based.
Contd...
6) Methods and Materials: It should include information on "Where," "Who," and "How" 
 the study will be conducted.
It covers the study's design and the procedures and techniques employed to attain the  
goals.
It outlines the variables and explains how they will be measured in detail. It explains the  
suggested data collection and processing approach.
The protocol's methodology is a key component. It guarantees that the theory will be  
proven or disproven. It also refers to a well-thought-out approach for achieving the  
goals
Contd...
 THE METHODS AND MATERIALS ARE DIVIDED INTO SEVERAL SUBHEADINGS
a) Study design (case-control, cross-sectional, intervention study, RCT, etc.): A thorough  
explanation of why a particular experimentdesign was chosen should be provided (based on  
proposed objectives and availability of resources).
The best way to prove a causal relationship between exposure and an outcome
is to  conduct a randomized controlled clinical trial.
b) Study population (Study subjects): Where will you conduct your research, and who will 
be  the study population (why are you conducting research in this location, and why have 
you  chosen this demographic?).
Contd...
Table: 3 Suitable research design depends on the purpose of the 
study.
c) Sample size: Calculating the sample size is suggested for both economic and ethical 
 reasons.
The sample size computation must be described, as well as the sample's power.
The sampling strategy, such as randomization that will be utilized acquire a
to  representative sample for your target population, should be indicated.
d) Proposed intervention: The suggested intervention should be described in detail.
All activities and acts should be documented and properly explained in the
sequence in  which they occurred.
Contd...
e) Data collection methods, instruments used:
Data collection tools are:
Retrospective data (medical records)
Questionnaires
Interviews (Structured, Semi-Structured)
A test in the laboratory (literature or individual knowledge should  be referenced if
conventional test or report should be provided in details, if not recognized)
Medical evaluations
A description of the instruments, the tools used to collect data, and the methodologies used  
to test the instrument's validity and reliability should be supplied.
Contd...
7) Data Management and Analysis Plan: This part should be 
 written with the help of a statistician's statistical advice.
The analytical plan and the statistical tests that will be utilized to  
verify the significance of the research question/hypothesis  
should be presented with suitable references.
If computer applications are to be used, the software used  
and its version must be specified.
8) Strengths and Limitations: It is critical to state the study's  
strengths and limitations, i.e., what the study can and cannot do 
 to avoid wasting resources.
Contd...
9) Ethical Considerations (Issues for Ethical Review and Approvals): It should
state  whether the processes to be followed comply with the Helsinki Declaration.
In any case, the study should not begin until the ethical committee has approved it. 
 The following points should be explained:
The advantages and disadvantages for the subjects involved. The research's
physical,  social, and psychological implications.
Information to be provided to study participants, including alternative treatments
and  techniques.
Contd...
Information about the participants' free and informed consent should be delivered.
Justification for research, study outline, risks, confidentiality, and voluntary
participation  should be included in the information form.
Patients should be educated of their right to withdraw from the study at any time.
Confidentiality refers to how the patient's personal information will be kept secret
(Data  safety).
Contd...
10) Operational Planning and Budgeting (Budget 
 Summary): Outline the budgetary requirements  
for the study, including staff, transportation,
instruments, laboratory testing, and drug costs.
An annexure with a budget estimate is required.
The budget includes all costs, including people,  
consumables, equipment,
supplies,  communication, and funds for patients 
and data  processing. Justification is required for 
each item.
Contd...
11) Reference System: The standard way of acknowledging information drawn from the 
 work of other academics is referencing.
Readers will be able to follow up on any references of interest if they are properly cited.
Plagiarism is the act of claiming and gaining someone else's ideas without
their  permission, and it is a crime.
Plagiarism is defined as failing to acknowledge the contribution of other team members  in a 
group assignment or failing to cite an idea uncovered in your research.
Contd...
As a result, reference is a critical component of the research protocol.
The Vancouver system and the Harvard system are the two most often used citation  
methods in clinical writing.
The referencing system chosen is determined by the funding organizations to which the  
study protocol is submitted.
These typically specify their preferred referencing system, which should be
properly  followed.
The Vancouver style is the most widely used in dental literature review
CONCLUSIO
N
The drafting of a protocol, which results in a brief but comprehensive document
that  summarises the project, is the most difficult stage of executing a research project.
When a proposal is straightforward, free of typographical errors, accurate, and easy to 
 understand, it is successful.
To conduct an acceptable study and receive truthful results, it is critical to understand  
the stages involved in designing a research protocol.
Contd...
The extra time invested in writing a strong protocol will save failures later on and assist  
d ata analysis.
If the protocol is not properly written and followed, it is doubtful that the project
will  deliver the results you desire.
Your chances of selling your proposal to awarding agency evaluators will be reduced
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