Protocol writing is a critical step in clinical research that involves developing a detailed plan or protocol for conducting a clinical trial. The protocol serves as a roadmap for the study, outlining the objectives, methodology, participant eligibility criteria, data collection procedures, and analysis plan. Here are key considerations when writing a protocol in clinical research: Study Objectives and Research Questions: Clearly define the primary and secondary objectives of the study. State the research questions or hypotheses that the study aims to answer. This sets the foundation for the study design and data analysis plan. Study Design: Describe the study design, such as randomized controlled trial (RCT), observational study, or non-inferiority trial. Specify the study phases (if applicable) and the allocation of study participants to different arms or groups. Justify the chosen design and explain how it aligns with the research objectives. Participant Selection and Eligibility Criteria: Define the inclusion and exclusion criteria for participant selection. These criteria should be specific and relevant to the study population. Consider factors such as age, gender, medical history, disease severity, and previous treatments. Interventions and Procedures: Describe the study interventions or treatments in detail. Specify the dosage, administration route, duration, and frequency of interventions. Document the study procedures, including data collection methods, laboratory tests, imaging techniques, and follow-up visits. Sample Size and Power Calculation: Provide a rationale for the sample size estimation. Explain the statistical power calculation, specifying the desired effect size, significance level, and power. Justify the selected values and ensure that the sample size is sufficient to detect the intended effect or difference. Data Collection and Management: Detail the data collection methods, including the use of case report forms (CRFs), electronic data capture (EDC) systems, or other data collection tools. Specify the variables to be collected, their measurement scales, and any scoring systems or questionnaires to be used. Describe the data management processes, data quality control procedures, and methods for ensuring data integrity. Statistical Analysis Plan: Outline the statistical analyses that will be performed on the collected data. Describe the primary and secondary endpoints, statistical tests, and methods for handling missing data and outliers. Specify any interim analyses, subgroup analyses, or sensitivity analyses that will be conducted. Ethical Considerations: Address ethical aspects, such as informed consent procedures, protection of participant confidentiality, and compliance with ethical guidelines and regulations. Discuss any potential risks and benefits to participants and how they will be mitigated. Outline the process for obtaining ethical approvals and reporting adverse events.

1. Welcome
PROTOCOL WRITING IN CLINICAL RESEARCH
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B.AISWARYA
PHARM.D

2. INDEX
 DEFINITION
 AIMS OF RESEARCH PROTOCOL
 PROTOCOL DEVELOPMENT TEAM
 BENEFITS OF PROTOCOL
 FACTORS CONSIDERED BEFORE WRITING PROTOCOL
 COMPONENTS OF RESEARCH PROTOCOL
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3. DEFINITION :
Clinical research is conducted according to a plan ( a PROTOCOL) A research protocol is a document that describes the
objective ,design ,methodology ,statistical considerations ,and organization of a clinical trail.
It also describes the eligibility of the participants ,the length of the study , the medications and related tests .the study plan
must be carefully designed to safeguard the health and safety of the participants ,as well to as answer specific research
questions
AIMS OF RESEARCH PROTOCOL:
 To raise the question to be researched and clarify its importance
 To collect existing knowledge and discuss the efforts of other researchers who have worked on the related questions
( LITERATURE REVIEW )
To formulate a hypothesis and objectives
To clarify ethical considerations
To suggest the methodology required for solving the question and achieving the objects
To discuss the requirements and limitations in achieving the objectives
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4. PROTOCOL DEVELOPMENT TEAM :
• Principal investigator
• Biostatician
• Medical monitor
• Research scientist
• Clinical research associate
• Medical writer
BENEFITS OF PROTOCOL :
• Allows the researcher to plan and review the project’s step
• Serves as a guide throughout the research
• Forces time and budget estimates
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5. FACTORS CONSIDERED BEFORE WRITING PROTOCOL ;
 What is the question (hypothesis ) ? what is 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 )
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Title of the study
Administrative details
Project summary
Introduction ,background(literature review)
Study objectives
Methods and materials
Data management and analysis plan
Project management
Strengths and limitations
Operational planning and budgeting
Reference system
Annexure
COMPONENTS OF THE PROTOCOL

7. TITLE OF THE STUDY :
Title of the study 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
It should carry maximum information about the topic in a few words
It is a good practice to keep a title with in 12-15 words
ADMINISTRATIVE DETAILS :
The following administrative details and a protocol content summary should follow the title page
Content page (list of relevant sections and subsections with corresponding page number )
Signature page signed by senior members of the research team and dated should confirm that
version concerned has been approved by them
Contact details for the research members listing protocol
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8. PROJECT SUMMARY :
• The summary should be distinctive, concise and should sum up all the essentials of the protocol
INTRODUCTION (BACKGROUND ) :
• The background to the project should be concise and refer to the subjects straight forwardly .In
writing the review, attention should be drawn to the positives ,negatives and limitation as of the
studies quoted
• Introduction should briefly answer the importance of the topic ,the purpose of the study and
benefits for the society from the study
• The definition should be clear so that reader can straight forwardly recognize real meaning of it .
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9. Aims should be logical ,coherent ,feasible ,concise, and realistic ,considering local
Conditions ,phrased to clearly meet the purpose of the study and related to what the specific
research is intended to accomplish
The objectives should be (SMART)
• S - Specific
• M- Measurable
• A- achievable
• R- relevant
• T- time based
They should be stated in action verbs that illustrates their purpose
i.e. to determine , to compare, to verify, to calculate, to reduce ,to describe etc
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STUDY OBJECTIVES (AIMS) :

10. METHODS AND MATERIALS :
It explains the study design, procedures and techniques used to achieve the proposed objectives
The methods and materials are divided into various subheadings
a) Study design
b) Study population (study subjects)
c) Sample size
d) Proposed intervention
e) Data collection methods ,instruments used
DATA MANGEMENT 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 with appropriate references should
be described
• Name of the 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
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11. PROJECT MANAGEMENT :
Proper time table for accomplishing each major step of the study should be defined
The personnel (Investigators ,assistants ,laboratory techniques etc) involved in the study or data collection should
be properly trained.
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
ETHICAL CONSIDERATIONS :
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
OPERATIONAL PLANNING AND BUDGETING (BUDGETING SUMMARY) :
Outline the budget requirement showing head wise expenditure for the study-manpower, transportation
instruments, laboratory tests , and cost of the drug, All costs including personnel, consumables ,equipments
supplies, funds for patients and data processing are included
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12. REFERENCE SYSTEM :
• Referencing is the regular method of recognizing information taken from other researcher’s work
• A proper citation will enable the readers to follow up any reference of interest .Plagiarism refers to
claiming and acquiring someone else ideas, an Action that is considered a criminal action.
• The two most commonly used citation systems in clinical writing are
• +Vancouver system
• +Harvard system
ANNEXURE :
• The following annexures are to be attached at the end of the protocol
• Informed consent form
• Letters from ethics committees
• Study questionnaire(copies of any questionnaires or draft questionnaires)
• Case record forms (CRFs)
• Budget details
• Curriculum vitae (CV) of the chief investigator and co-investigator and their role in the study
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13. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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