DOI: 10.7860/JCDR/2016/21426.

8865
Review Article

Protocol Writing in Clinical

Dentistry Section
Research

Azzam Al Jundi1, Salah Sakka2

ABSTRACT
Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of
postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for
producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant
for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition.
Keywords: Academia, Grant, Higher Education, Researcher

What is a Protocol? colleagues and experts so that researchers can develop their plans.
Clinical research is conducted according to a plan (a protocol) However, once the study is launched, the protocol should not be
or an action plan. The protocol demonstrates the guidelines for altered during the progression of the study or trials. If the changes
conducting the trial. It illustrates what will be made in the study by during progress of study are minor, then that part of the study should
explaining each essential part of it and how it is carried out. It also be excluded from the analysis. Unless unexpected complications
describes the eligibility of the participants, the length of the study, occur during the conduct of the trial, it is advisable to reconsider
the medications and the related tests. and rewrite the protocol where the whole process is started again
A protocol is directed by a chief researcher. The health of the provided that the original research topic is still considered to be
participants’ will be regularly checked by members of the research relevant. If complications are anticipated, it is suitable to run a pilot
team to ultimately ensure the study’s safety and effectiveness. study, to check the feasibility of the study and find answers to the
potential areas of the trial.
Purpose of a Research Proposal
[Table/Fig-1] outlines the key aims of the protocol. What is a Protocol Review?
Clinical trials must be approved and monitored by an Institutional
Aims Review Board that ensures that the risks are negligible and are
worth any potential benefits. It is an independent committee that
1) To raise the question to be researched and clarify its importance.
2) To collect existing knowledge and discuss the efforts of other researchers who consists of physicians, dentists, statisticians, and members of the
have worked on the related questions (Literature review). community.
3) To formulate a hypothesis and objectives.
4) To clarify ethical considerations. The committee ensures that clinical trials are ethical and that the
5) To suggest the methodology required for solving the question and achieving the rights of all participants are protected. The board must initially
objectives.
6) To discuss the requirements and limitations in achieving the objectives.
approve and periodically review the research.
[Table/Fig-1]: Aims of the protocol. Components of a Research Protocol: The topics that should be
covered in a protocol are shown in [Table/Fig-3] [3,4].
Benefits of the Proposal to a Researcher
[Table/Fig-2] outlines the key benefits of the protocol. Writing the Protocol
Protocol writing allows the researcher to review and critically evaluate
Benefits
the published literature on the interested topic, plan and review the
Allows the researcher to plan and review the project's steps. project steps and serves as a guide throughout the investigation.
Serves as a guide throughout the research. The proposal is an inevitable document that enables the researcher
Forces time and budget estimates.
to monitor the progress of the project [5].
[Table/Fig-2]: Benefits of the protocol.
1) Title of the Study: Title of proposal should be accurate, short,
The key points of the proposal should include justification for the concise, and identify [2,6].
need of the project and a detailed plan for the investigation [1,2]: What is the study about, Who are the targets, Where is the setting
What is the question? (Hypothesis) What is it to be investigated? of the study and when it is launched, if applicable-
• Why is the study important? (Significance)
Components
• Where and when it will take place?
1) Title of the study
• What is the methodology? (Procedures and methods to 2) Administrative details
3) Project summary
be used). 4) Introduction to the research topic, background (Literature review)
• How are you going to do it? (Research design) 5) Preliminary studies
6) Study objectives and/or questions. Statement of the problem.
• Proposed time table and budget. 7) Methodology: Study design, study population and methods of recruitment,
variables list, sample size, methods of data collection, data collection tools,
• Resources required (technical, scientific, and financial). plan of analysis (analysis of data)
Drafting the protocol correctly will increase the likelihood that the 8) Project management: Work plan (Timeline - proposed schedule)
9) Strengths and limitations of the study
conclusions drawn from the research are scientifically sound. 10) Issues for ethical review and approvals
Recommendations and suggestions should be sought from [Table/Fig-3]: The components of the protocol.

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www.jcdr.net Azzam Al Jundi and Salah Sakka, Protocol Writing

It should make the main objective clear, convey the main purpose The formulation of objectives helps to focus the study and to avoid
of the research and mention the target population. Carry maximum the collection of any unnecessary data and hence organize the
information about the topic in a few words; it is a good practice to study in clear and distinct stages.
keep the title to within 12-15 words. It should convey the idea about Hypothesis: It is a statement based on sound scientific theory
the area of research and what methods are going to be used in that recognizes the predicted correlation between two or additional
a compact, relevant, accurate, attractive, easy to understand, and assessable variables [11]. It is always developed in response to
informative way. the purpose statement or to answer the research questions posed.
2) Administrative Details: The following administrative details and Furthermore, hypothesis transforms research questions into a
a protocol content summary should follow the title page: format amendable to testing or into a statement that predicts an
• Contents page list of relevant sections and sub-sections expected outcome.
with corresponding page number. Types of hypothesis statements:
• Signature page is signed by senior members of the • Null hypothesis: A null hypothesis is a statement that
research team and dated to confirm that the version there is no actual relationship between variables (H0 or
concerned has been approved by them. HN). It may be read as there is no difference between
• Contact details for the research team members listing the groups to be compared and no relationship between
postal and e-mail addresses and telephone numbers for the exposure and outcome under investigation. H0
members of the research team. states the contradictory of what the researchers expect.
The final conclusion of the investigators will either keep
3) Project Summary: The summary should be distinctive, concise
a null hypothesis or reject it in support of an alternative
and should sum up all the essentials of the protocol.
hypothesis. It does not essentially mean that H0 is
4) Introduction (Background): The background to the project accurate when not rejecting it as there might not be an
should be concise and refer to the subject straight forwardly. In writing adequate proof against it.
the review, attention should be drawn to the positives, negatives and
• Alternative hypothesis: An alternative hypothesis is
limitations of the studies quoted [7-9]. Introduction is concluded by
a statement that suggests a potential outcome that the
explaining how the present study will benefit the community. The
researcher may expect (H1 or HA). This hypothesis is
literature review should logically lead to the statement of the aims of
derived from previous studies where an evident difference
the proposed project and end with the aims and objectives of the
between the groups to be compared is present. It is
study. The review should include the most recent publications in the
recognized only when a null hypothesis is rejected.
field and the topic of the research is selected only after completing
Practically, hypotheses are stated in the null form, because
the literature review and finding some gaps in it.
they have their inferential statistics. Such hypotheses of
Introduction should briefly answer the importance of the topic, the no difference will be challenged by researchers and the
gaps/lacunae in the literature, the purpose of the study and benefits result of the statistical testing gives the probability that the
for the society, from the study. hypothesis of no difference is true or false [12].
The research question should be described precisely and concisely. Aims should be logically linked and arranged according to the tested
It is going to be the basis of designing the project. The definition of hypothesis statement.
the problem should be clear so that a reader can straight forwardly
Example:
recognize the real meaning of it.
• Research question: Is there a difference in fluoride release
5) Study Objectives (Aims): The aims should be explicitly stated.
between the Compomer and Glass- ionomer cement?
These should be confined to the intention of the project and they
should arise from the literature review. State the goal you need to • Null Hypothesis: There is no difference in fluoride release
achieve. between the Compomer and Glass- ionomer cement.
The study aims or objectives emerge from the study questions/ • Alternate Hypothesis: There is a difference in fluoride
hypothesis. They are answers to what are the possible responses release between the Compomer and Glass-ionomer
to the research question or hypothesis under analysis and measure. cement.
Aims should be logical and coherent, feasible, concise, realistic, The statement of the problem should provide a summary of exactly
considering local conditions, phrased to clearly meet the purpose what the project is trying to achieve.
of the study and related to what the specific research is intended • What exactly do you want to study?
to accomplish. For example, to evaluate knowledge level regarding
• Why is it worth studying?
dental caries in primary school children in KSA (this is not detailed).
The following should be added: Causes, treatment, preventive • Does the proposed study have theoretical and/or practical
measures, etc. significance?
The objectives should be (SMART objective): Specific, Measurable, • Does it contribute to a new understanding of a
Achievable, Relevant and Time based [10]. phenomenon? (i.e., Does it address new or little known
material or does it treat familiar material in a new way or
Specific Aims: Details of each objective that will finally lead to the
does it challenge an existing understanding or extend
achievement of the goal should be stated. Specific aims one by
existing knowledge?)
one should be listed concisely. It is good practice not to include too
many aims in the study (2-5 best); too many objectives often lead The justification of the research should be a convincing statement
to inaccurate and poorly defined results. Furthermore, aims should for the need to do it:
be achievable, realistic and specific with no general and ambiguous • How does the research relate to the priorities of the region
statements. They should be stated in action verbs that illustrate their and the country?
purpose: i.e., “to determine, to compare, to verify, to calculate, to • What knowledge and information will be obtained?
reduce, to describe, etc.”
• What is the ultimate purpose that the knowledge obtained
Secondary Objectives (Optional): These are referred to as from the study will serve?
ancillary and minor objectives that could be studied during the
• How will the results be disseminated?
course of the study.

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• How will the results be used, and who will be the company, city, and country. Drug route, dosage, frequency
beneficiaries? of administration, and total duration of treatment with the
6) Methods and Materials: It should describe in detail the drug should be mentioned.
‘Where’, ‘Who’, ‘How’ the research will be conducted. It explains • When using apparatus its name should be given followed
the study design and procedures and techniques used to achieve by the name of the manufacturer, city and country.
the proposed objectives. It defines the variables and demonstrates Involved personnel should precisely define:
in detail how the variables will be measured. It details the proposed
• Who will be responsible for the interventions?
methodology for data gathering and processing.
• What activities each personnel will perform and with what
Methodology composes an important part of the protocol. It assures
frequency and intensity?
that the hypothesis will be confirmed or rejected. It also refers to a
thorough strategy to attain the objectives [13]. e) Data collection methods, instruments used:
The methods and materials are divided into various subheadings: Data collection tools are:
a) Study design (cross-sectional, case-control, intervention • Retrospective data (medical records) [19]
study, RCT, etc.): Proper explanation should be given as to why a • Questionnaires [20]
particular design was chosen (on the basis of proposed objectives • Interviews (Structured, Semi-Structured)
and availability of resources).
• Laboratory test (literature or personal knowledge should
A study design is in fact the researcher’s general plan to acquire be referenced, if established test, or description should
the answer (s) to the hypothesis being tested. Here, strategies will be provided in details, if not established)
be applied to develop balanced, correct, objective and meaningful
• Clinical examinations
information [14]. It explains the methods that will be used to collect
and analyze data. Proper selection of the study design is important • Description of instruments, tools used for data collection,
to attain reliable and valid scientific results. as well as the methods used to test the validity and
reliability of the instrument should be provided [21].
Ethics, logistic concerns, economic features and scientific thorough-
ness will determine the design of the study. Here, a chief concern is 7) Data Managements and Analysis Plan: This section should
given to the legality of the results including potential bias mystifying be written following statistical advice from a statistician. The analysis
issues. plan and which statistical tests will be used to check the significance
to the research question/hypothesis with appropriate references
Randomized controlled clinical trial is the best to document a causal
should be described. Names of variables that will be used in the
relationship between an exposure and its outcome [Table/Fig-4].
analyses and the name of statistical analysis that will be performed
b) Study population (Study subjects): Where are you going to do to assess the outcome should be listed [22-25].
the research and who is the study population (why doing research in
If computer programs are to be applied, it is important to mention
this place and why selecting this population?).
the software used and its version.
It describes in detail about the study subjects, all aspects of the
8) Project Management: Work plan-A work plan is an outline of
selection procedure and sample size calculation. Proper definition
activities of all the phases of the research to be carried out according
of eligibility, inclusion, exclusion and discontinuation criteria of the
to an anticipated time schedule.
study subjects should be stated. Allocation of subjects to study
arms should be explained and described in details bearing in mind Proper time table for accomplishing each major step of the study
the concealment and randomization process [15,16]. should be defined. Assigning time frame to each step in the trial
will be helpful in organizing the structure of the research trial. The
c) Sample size: Sample size calculation is recommended for
personnel (investigators, assistants, laboratory technicians etc.)
economical and ethical reasons [16-18]. The calculation of the
involved in the study or data collection should be properly trained.
sample size must be explained including the power of the sample.
The sampling technique should be mentioned, e.g., randomization 9) Strengths and Limitations: It is important to mention the
that will be used in order to obtain a representative sample for your strengths or limitations of the study, i.e., what study can achieve or
target population. Each step involved in the recruitment of the study cannot achieve is important, so as to prevent wasteful allocation of
subjects should be described according to the selection criteria resources.
(inclusion and exclusion criteria). 10) Ethical Considerations (Issues for Ethical Review and
“Informed consent” should be mentioned (Permission granted in full Approvals): It should indicate whether the procedures to be
knowledge of the possible consequences). followed are in accord with the Declaration of Helsinki. In any case,
study should not start unless approval from ethics committee is
d) Proposed intervention: Full description of proposed intervention
received [26].
should be given. Here, all the activities and actions should be
recorded and thoroughly explained in their order of occurrence. The following points should be explained:
• When using drugs, both scientific and brand name should • The benefits and risks for the subjects involved. The
be mentioned followed by the name of the manufacturing physical, social and psychological implications of the
research.
Purpose Study Design
• Details of the information to be given to the study patients
To determine frequency and burden of a * Cross-sectional survey (Prevalence) including alternative treatments/approaches.
disease * Cohort study (Incidence)
• Information should be provided on the free informed
To identify the risk factors * Cohort study consent of the participants. Information form should
* Case-Control study
contain: Justification for research, outline of study, risks,
To determine prognosis of a disease * Cohort study confidentiality, and voluntary participation should be told
To determine efficacy/effectiveness of a * Clinical trials patients about the freedom to withdraw from the study
new treatment * Community intervention whenever they wish to. Confidentiality indicates how the
To evaluate community programs * Evaluation
personal information obtained from the patient will be
kept secret (Data safety).
[Table/Fig-4]: Suitable research design depends on the purpose of the study.

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www.jcdr.net Azzam Al Jundi and Salah Sakka, Protocol Writing

11) Operational Planning and Budgeting (Budget Summary): document that clearly summarizes the project. Such proposal is
Outline the budget requirement showing head wise expenditure for the considered successful when it is clear, free of typographical errors,
study-manpower, transportation, instruments, laboratory tests, and accurate and easy to read.
cost of the drug. Budget estimate is to be attached in the annexure. It is important to understand the steps in developing a research
All costs including personnel, consumables, equipment, supplies, protocol in order to perform an appropriate study and obtain reliable
communication, and funds for patients and data processing are all results. Extra time spent to write a good protocol will save failures
included in the budget. Each item should be justified. at a later stage besides helping analysis. If the protocol is poorly
12) Reference System: Referencing is the regular method of prepared and not adhered to, it is unlikely that the project will yield
recognizing information taken from other researchers’ work. A the information that you hope for and in all probability the chances
proper citation will enable the readers to follow-up any reference of of selling your idea to the reviewers of a granting agency would be
interest. Plagiarism refers to claiming and acquiring someone else’s less.
ideas, an action that is considered a criminal action.
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PARTICULARS OF CONTRIBUTORS:
1. Professor, Department of Orthodontics, King Saud bin Abdul Aziz University for Health Sciences, College of Dentistry, Riyadh, Kingdom of Saudi Arabia.
2. Associate Professor, Department of Oral Surgery, Al Farabi Dental College, Riyadh, Kingdom of Saudi Arabia.

NAME, ADDRESS, E-MAIL ID OF THE CORRESPONDING AUTHOR:

Dr. Salah Sakka,
Al-farabi Dental College, Riyadh-11691, Kingdom of Saudi Arabia. Date of Submission: May 15, 2016
E-mail: [email protected] Date of Peer Review: Jul 02, 2016
Date of Acceptance: Aug 20, 2016
Financial OR OTHER COMPETING INTERESTS: None. Date of Publishing: Nov 01, 2016

Journal of Clinical and Diagnostic Research. 2016 Nov, Vol-10(11): ZE10-ZE13 13