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Preparation of Article based on the Study

Protocol

Dr. Nancy Agnes, Head, Technical Operations, Pubrica sales@pubrica.com

In brief:

A protocol 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.

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(1)

.

I. INTRODUCTION

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. 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(2)

.

Table: 1 the key aims and benefits of the protocol

Aims Benefits

1) To identify the research question and clarify its

significance.

2) To gather current knowledge and discuss the work

of other scholars who have undertook similar issues

(Literature review).

3) To come up with a hypothesis and a set of goals.

4) To make ethical considerations more clear.

5) Propose an approach for resolving the problem

and accomplishing the objectives.

6) To talk about the requirements and constraints in

reaching the objectives.

The researcher can plan and review the project's

steps with this tool.

Throughout the research, it acts as a guide.

Estimates of time and budget are compelled..

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.

II. COMPONENTS OF A RESEARCH PROTOCOL

The Clinical trials must 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.

Copyright © 2021 pubrica. All rights reserved 2

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 (3)

.

Table: 2 components of the protocol

Components

1) Title of the study

2) Administrative details

3) Project summary

4) Introduction to the research topic, background (Literature review)

5) Preliminary studies

6) Study objectives and questions—statement of the difficult.

7) Study design, study population, and recruiting techniques, variables list, sample size, data collection

techniques, data collection instruments, and analytic plan (analysis of data)

8) Project organization: Work plan (Timeline - proposed schedule)

9) Strengths and limitations of the study

10) Issues for ethical review and approvals

III. WRITING THE PROTOCOL

Protocol 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 (4)

.

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.

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.

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

5)

6) community. The literature review services 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.

7) 5)Study Objectives (Aims): The study

questions/hypotheses lead to the study goals or

objectives. 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.

8) 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 (5)

.

The methods and materials are divided into

several subheadings:

a) a)Study design (case-control,cross-sectional,

intervention study, RCT, etc.): A thorough

explanation of why a particular expertimental design

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.

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Table: 3 Suitable research design depends on the purpose of the study.

Purpose Study Design

To determine the frequency and burden of a disease * Cross-sectional survey (Prevalence)

* Cohort study (Incidence)

To identify the risk factors *Cohort study

* Case-Control study

To determine the prognosis of a disease * Cohort study

To determine the efficacy/effectiveness of a new

treatment

* Clinical trials

* Community intervention

To evaluate community programs * Evaluation

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?).

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 to acquire a

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.

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.

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.

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.

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).

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.

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. 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 (6)

Copyright © 2021 pubrica. All rights reserved 4

IV. CONCLUSION

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. The extra time invested in writing

a strong protocol will save failures later on and assist

data 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(7)

.

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3. Carøe, Christian, and Kristine Bohmann.

"Tagsteady: a metabarcoding library preparation

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