This document provides an overview of protocol writing for clinical research. It defines a research protocol as outlining the study plan to safely answer research questions while protecting participants. The summary outlines key components of a protocol including objectives, methodology, and management plans. A protocol allows researchers to plan, review steps, and guide the investigation. Developing a protocol requires considering factors like the research question, importance, methods, and resources needed before writing each required component.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
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.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
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.
measurement of GFR and creatinine clearence-- design of dosage for hepatic patients -- therapeutic drug monitoring and clinical pharmacokinetics fifth pharm D notes
Genetic polymorphism in drug transport and drug targets.pavithra vinayak
Genetic polymorphism in drug transport and targets.--pharmacogenetics
DRUG TRANSPORTER
Two types of transporter :
•ATP binding Cassette (ABC) – Found in ABCB, ABCD and ABCG family. Associated with multidrug resistance (MDR) of tumor cells causing treatment failure in cancer.
•Solute Carrier (SLC) – Transport varieties of solute include both charged or uncharged
P-glycoprotein
• ATP binding cassette subfamily B member- 1 (ABCB 1)
• Multidrug resistance protein 1 (MDR1)
• Transport various molecules, including xenobiotic, across cell membrane
• Extensively distributed and expressed throughout the body
Mechanism of Pglycoprotein
Substrate bind to P-gp form the inner leaflet of the membrane
ATP binds at the inner side of the protein
ATP is hydrolyzed to produce ADP and energy
Clinical pharmacokinetics and its application--
1)definition
2) APPLICATIONS OF CLINICAL PHARMACOKINETICS
Design of dosage regimens:
a) Nomograms and Tabulations in designing dosage regimen,
b) Conversion from intravenous to oral dosing,
c) Determination of dose and dosing intervals,
d) Drug dosing in the elderly and pediatrics and obese patients.
Pharmacokinetics of Drug Interaction:
a) Pharmacokinetic drug interactions
b) Inhibition and Induction of Drug metabolism
c) Inhibition of Biliary Excretion.
Therapeutic Drug monitoring:
a) Introduction
b) Individualization of drug dosage regimen (Variability – Genetic, Age and Weight, disease, Interacting drugs).
c) Indications for TDM. Protocol for TDM.
d) Pharmacokinetic/Pharmacodynamic Correlation in drug therapy.
e) TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations
Dosage adjustment in Renal and Hepatic Disease.
a. Renal impairment
b. Pharmacokinetic considerations
c. General approach for dosage adjustment in renal disease.
d. Measurement of Glomerular Filtration rate and creatinine clearance.
e. Dosage adjustment for uremic patients.
f. Extracorporeal removal of drugs.
g. Effect of Hepatic disease on pharmacokinetics.
Population Pharmacokinetics.
a) Introduction to Bayesian Theory.
b) Adaptive method or Dosing with feedback.
c) Analysis of Population pharmacokinetic Data
Therapeutic drug monitoring for immunosuppressive agents ( organ transplants)pavithra vinayak
Therapeutic drug monitoring for immunosuppressive agents ( organ transplants)
1)CALCINEURIN INHIBITORS
i. CYCLOSPORIN/ CYCLOSPORINE
ii. SIROLIMUS
iii. TACROLIMUS
iv. EVAROLIMUS
2) ANTIPROLIFERATIVE/ANTIMETABOLIC AGENTS,
i. MYCOPHENOLATE
ii. AZATHIOPRINE
3) BIOLOGICS (ANTIBODIES)
i. MUROMONAB-CD3 (OKT3)
ii. BASILIXIMAB
iii. DACLIZUMAB
iv. ALEMTUZUMAB
v. ANTITHYMOCYTE GLOBULIN
4)GLUCOCORTICOIDS,
clinical pharmacokinetics and therapeutic drug monitoring ----- fifth pharm D notes
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
Nomograms and tabulations in design of dosage regimens pavithra vinayak
Nomograms and tabulations in the design of dosage regimens --- NOMOGRAM IN UREMIC PATIENTS: NOMOGRAM FOR RELATIONSHIP BETWEEN CREATININE CLEARANCE AND ELIMINATION RATE CONSTANT FOR FOUR DRUGS clinical pharmacokinetics and therapeutic drug monitoring ---fifth PharmD notes
adaptive methods are doing with feedback in population pharmacokinetics---- clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
Bayesian theory in population pharmacokinetics--
1) INTRODUCTION TO BAYESIAN THEORY
2)BAYESIAN PROBABILITY TO DOSING OF DRUGS
3)APPLICATIONS AND USES OF BAYESIAN THEORY IN APPLIED PHARMACOKINETICS:
therapeutic drug monitoring and clinical pharmacokinetics-fifth pharm d notes
depression ,symptoms, mechanism of depression ,classification of antidepressants , tri cyclic anti depressants and its pharmacological actions ,acute poisoning and treatment
introduction ,classification of cholinergic receptor ,and its function ,anti cholinergic agents -atropine and its pharmacology ,semi synthetic and synthetic atropine substitutes
principle action of drugs,types of angina classification of drugs ,nitrates,calcium channel blockers pharmacological actions ,combination therapy and its sid effects
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
2. 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:
3. 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)
4. 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
5. 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:
6. 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.
7. 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.
8. 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.
9. 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 .
10. 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
11. 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
12. 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.
13. 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):
14. 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.
15. 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.
16. 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