protocol writing in clinical research

CLINICAL RESEARCH
ASSIGNMENT ON
PROTOCOL WRITING IN CLINICAL
RESEARCH
SUBMITTED BY
PAVITHRA .V
V-PHARMD

PROTOCOL WRITING IN CLINICAL RESEARCH
DEFINITION:
‘A research protocol is the document that contains a set of rules and
outlines the study plan for a clinical research project. The study plan
must be carefully designed to safeguard the health and safety of the
participants, as well to as answer specific research questions.’
FLOW OF STUDY:

AIMS OF RESEARCH PROTOCOL:
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 have worked on the related questions (Literature
review).
3) To formulate a hypothesis and objectives.
4) To clarify ethical considerations.
5) To suggest the methodology required for solving the question and
achieving the objectives.
6) To discuss the requirements and limitations in achieving the
objectives.
BENEFITS OF PROTOCOL:
 Allows the researcher to plan and review the project’s steps.
 Serves as a guide throughout the research.
 Forces time and budget estimates.
FACTORS CONSIDERED BEFORE WRITING PROTOCOL:
 What is the question? (Hypothesis) What is it to be
investigated?
 Why is the study important? (Significance)
 Where and when it will take place?
 What is the methodology? (Procedures and methods to be
used).
 How are you going to do it? (Research design)

 Proposed time table and budget.
 Resources required (technical, scientific, and financial).
COMPONENTS OF RESEARCH PROTOCOL:
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/or questions. Statement of the problem.
7) Methodology: Study design, study population and methods of
recruitment, variables list, sample size, methods of data
collection, data collection tools, plan of analysis (analysis of
data)
8) Project management: Work plan (Timeline - proposed
schedule)
9) Strengths and limitations of the study
10) Issues for ethical review and approvals
Protocol writing allows the researcher to review and
critically evaluate the published literature on the interested topic,
plan and review the project steps and serves as a guide throughout

the investigation. The proposal is an inevitable document that
enables the researcher to monitor the progress of the project.
1) TITLE OF THE STUDY:
Title of proposal should be accurate, short, concise, and
identify
What is the study about,
Who are the targets,
Where is the setting of the study and
When it is launched, if applicable-
CHARECTERISTICS:
It should make the main objective clear, convey the main
purpose of the research and mention the target population.
Carry maximum information about the topic in a few words;
it is a good practice to keep the title to within 12-15 words.
It should convey the idea about the area of research and what
methods are going to be used in a compact, relevant, accurate,
attractive, easy to understand, and informative way.
2) ADMINISTRATIVE DETAILS:
The following administrative details and a protocol content
summary should follow the title page:

 Contents page list of relevant sections and sub-sections with
corresponding page number.
 Signature page is signed by senior members of the research team and
dated to confirm that the version concerned has been approved by
them.
 Contact details for the research team members listing postal, e-mail
addresses and telephone numbers.
3) PROJECT SUMMARY:
The summary should be distinctive, concise and should sum up all
the essentials of the protocol.
4) INTRODUCTION (BACKGROUND):
The background to the project should be concise and refer to
the subject straight forwardly. In writing the review, attention
should be drawn to the positives, negatives and limitations of
the studies quoted .
CHARECTERISTICS:
Introduction is concluded by explaining how the present study
will benefit the community.
The literature review should logically lead to the statement of
the aims of the proposed project and end with the aims and
objectives of the study.
The review should include the most recent publications in the
field and the topic of the research is selected only after
completing the literature review and finding some gaps in it.

Introduction should briefly answer the importance of the topic,
the gaps/lacunae in the literature, the purpose of the study and
benefits for the society, from the study.
The research question should be described precisely and
concisely. It is going to be the basis of designing the project.
The definition of the problem should be clear so that a reader
can straight forwardly recognize the real meaning of it.
5) STUDY OBJECTIVES (AIMS):
Aims should be logical and coherent, feasible, concise,
realistic, considering local conditions, phrased to clearly
meet the purpose of the study and related to what the
specific research is intended to accomplish.
For example, to evaluate knowledge level regarding dental
caries in primary school children in KSA (this is not detailed).
The following should be added: Causes, treatment, preventive
measures, etc.
The objectives should be
(SMART objective): Specific,
Measurable,
Achievable,
Relevant and
Time based
Specific Aims:
Specific aims one by 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 to inaccurate and poorly
defined results.
They should be stated in action verbs that illustrate their purpose:
i.e., “to determine, to compare, to verify, to calculate, to
reduce, to describe, etc.”
Secondary Objectives (Optional): These are referred to as ancillary
and minor objectives that could be studied during the course of the
study.
The formulation of objectives helps to focus the study and to avoid
the collection of any unnecessary data and hence organize the
study in clear and distinct stages.
Hypothesis: It is a statement based on sound scientific theory that
recognizes the predicted correlation between two or additional
assessable variables. It is always developed in response to the
purpose statement or to answer the research questions posed.
TYPES OF HYPOTHESIS STATEMENTS:
Null hypothesis:
A null hypothesis is a statement that there is no actual
relationship between variables (H0 or HN)
H0 states the contradictory of what the researchers expect. The
final conclusion of the investigators will either keep or reject
It does not essentially mean that H0 is accurate when not
rejecting it as there might not be an adequate proof against it.

 Alternative hypothesis:
An alternative hypothesis is a statement that suggests a
potential outcome that the researcher may expect (H1 or HA).
This hypothesis is derived from previous studies where an
evident difference between the groups to be compared is
present. It is recognized only when a null hypothesis is
rejected.
Such hypotheses of no difference will be challenged by
researchers and the result of the statistical testing gives the
probability that the hypothesis of no difference is true or false .
Example:
Research question: Is there a difference in fluoride release
between the Compomer and Glass- ionomer cement?
Null Hypothesis: There is no difference in fluoride release
between the Compomer and Glass- ionomer cement.
Alternate Hypothesis: There is a difference in fluoride release
between the Compomer and Glass-ionomer cement.
6) METHODS AND MATERIALS:
It explains the study design and procedures and techniques
used to achieve the proposed objectives.
It defines the variables and demonstrates in detail how the
variables will be measured.
It details the proposed methodology for data gathering and
processing.
Methodology composes an important part of the protocol. It
assures that the hypothesis will be confirmed or rejected. It
also refers to a thorough strategy to attain the objectives .

The methods and materials are divided into various subheadings:
a) Study design (cross-sectional, case-control, intervention study,
RCT, etc.):
A study design is in fact the researcher’s general plan to acquire
the answer (s) to the hypothesis being tested. Here, strategies will
be applied to develop balanced, correct, objective and meaningful
information .
Purpose Study Design
To determine 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 prognosis of a disease * Cohort study
To determine efficacy/effectiveness of
a new treatment
* Clinical trials
* Community intervention
To evaluate community programs * Evaluation

b) Study population (Study subjects):
It describes in detail about the study subjects, all aspects of the
selection procedure and sample size calculation.
Proper definition of eligibility, inclusion, exclusion and
discontinuation criteria of the study subjects should be stated.
Allocation of subjects to study arms should be explained and
described in details bearing in mind the concealment and
randomization process .
c) Sample size:
Sample size calculation is recommended for economical and
ethical reasons . The calculation of the sample size must be
explained including the power of the sample.
The sampling technique should be mentioned, e.g.,
randomization that will be used in order to obtain a
representative sample for your target population.
Each step involved in the recruitment of the study subjects
should be described according to the selection criteria (inclusion
and exclusion criteria).
“Informed consent” should be mentioned (Permission granted in
full knowledge of the possible consequences).
d) Proposed intervention:
Full description of proposed intervention should be given.
 When using drugs, both scientific and brand name should
be mentioned followed by the name of the manufacturing
company, city, and country. Drug route, dosage, frequency of

administration, and total duration of treatment with the drug
should be mentioned.
 When using apparatus its name should be given followed
by the name of the manufacturer, city and country.
 Involved personnel should precisely define:
 Who will be responsible for the interventions?
 What activities each personnel will perform and with what
frequency and intensity?
e) Data collection methods, instruments used:
Data collection tools are:
 Retrospective data (medical records)
 Questionnaires
 Interviews (Structured, Semi-Structured)
 Laboratory test (literature or personal knowledge should be
referenced, if established test, or description should be
provided in details, if not established)
 Clinical examinations
 Description of instruments, tools used for data collection, as
well as the methods used to test the validity and reliability of
the instrument should be provided .
7) DATA MANAGEMENT AND ANALYSIS PLAN:
 This section should be written following statistical advice from
a statistician.

 The analysis plan and which statistical tests will be used to
check the significance to the research question/hypothesis with
appropriate references should be described.
 Names of variables that will be used in the analyses and the
name of statistical analysis that will be performed to assess the
outcome should be listed .
 If computer programs are to be applied, it is important to
mention the software used and its version.
8) PROJECT MANAGEMENT:
 Proper time table for accomplishing each major step of the
study should be defined.
 Assigning time frame to each step in the trial will be helpful in
organizing the structure of the research trial.
 The personnel (investigators, assistants, laboratory technicians
etc.) involved in the study or data collection should be
properly trained.
9) STRENGTHS AND LIMITATIONS:
It is important to mention the strengths or limitations of the
study,
i.e., what study can achieve or cannot achieve is important, so as
to prevent wasteful allocation of resources.
10) Ethical Considerations (Issues for Ethical Review and
Approvals):

It should indicate whether the procedures to be followed are in
accord with the Declaration of Helsinki. In any case, study should
not start unless approval from ethics committee is received [26].
The following points should be explained:
 The benefits and risks for the subjects involved. The physical,
social and psychological implications of the research.
 Details of the information to be given to the study patients
including alternative treatments/approaches.
 Information should be provided on the free informed consent of the
participants. Information form should contain: Justification for
research, outline of study, risks, confidentiality, and voluntary
participation should be told patients about the freedom to withdraw
from the study whenever they wish to. Confidentiality indicates
how the personal information obtained from the patient will be
kept secret (Data safety).
10) OPERATIONAL PLANNING AND BUDGETING
(BUDGET SUMMARY):
Outline the budget requirement showing head wise
expenditure for the study-manpower, transportation,
instruments, laboratory tests, and cost of the drug.
Budget estimate is to be attached in the annexure. All costs
including personnel, consumables, equipment, supplies,
communication, and funds for patients and data processing are
all included in the budget.

11) REFERENCE SYSTEM:
o Referencing is the regular method of recognizing
information taken from other researchers’ work.
o A proper citation will enable the readers to follow-up any
reference of interest. Plagiarism refers to claiming and
acquiring someone else’s ideas, an action that is considered a
criminal action.
o The two most commonly used citation systems in clinical
writing are the
+ Vancouver system
+Harvard system.
13) ANNEXURE:
The following annexes are to be attached at the end of the protocol:
i.Informed consent form.
ii.Letters from ethics committees.
iii.Study questionnaire (copies of any questionnaires or draft
questionnaires).
iv.Case Record Forms (CRFs).
v.Budget details.
vi.Curriculum Vitae (CV) of the chief investigator and co-
investigator and their role in the study. It will ensure that the role
of each investigator is well defined.

REFERENCES:
1)NCBI- journal o clinical and diagnostic research JCDR- guidelines
for writing a protocol
2)ICH- guidelines for protocol
3) Bowling A. Research methods in health: Investigating health and
health services research. 4th ed. Maidenhead, England: Open
University Press; 2002.
4) O’Brien K, Wright J. How to write a protocol. J
Orthod. 2002;29(1):58–61

protocol writing in clinical research

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