Dr. Naveed Zafar Janjua
Chief Research Officer, PakMediNet
Although there are specific principles behind every research but every project or study is unique in its situation and requires special attention for its design and execution.
Quality of any research study depends on how well both design and execution phases of
the project are accomplished. There is a positive relation ship between the research
protocol and overall quality and acceptance of the resulting research study .
A research protocol is roadmap that guide and investigator from conceiving an idea to
publishing results. To be brief every study should be planned. An unplanned study
according one of my teachers is a fishing expedition.
Planning is done before the conduct. How ever before you plan to do some thing you must know what you want to do i.e., `idea`, a thought that can be your own or
generated in some one else mind.
This idea is transformed in to a research question that you want to answer.
Now before just jumping into planning look for the things other have done, i.e., literature
review. It is very important and essential component that tells you what other has
done and how they have done. If question conceived by you is already answered, there is no
need of doing this because it will not add any thing new to the existing literature.
Now the idea you have conceived should be phrased and formulated in the answerable
scientific research question. It should not be too big or ambiguous.
Methodology of any study is based on the way research question is posed and designed is
also guided by this.
When you have a good protocol, operational plan and budget to conduct study you can do
a good study.
It is excellent that protocol is reviewed by those who are expert in research
methodologies (Epidemiologist) and some person in the relevant field.
The components of a Research Protocol
- A descriptive title
- The name, titles, degrees, addresses and affiliations of the investigators and
- Introduction & Background
- Literature review
- Justification/ Rationale
- Study objective and /or research questions
- Study Methodology
- Study population and its recruitment
- Study design
- Study setting
- Study duration
- Sample size determination
- Sampling strategy
- Variable list
- Methods of data collection
- Data collection tools
- Plan of Analysis
- Ethical considerations & humane subject protection
- Quality control
- Expected benefits from the study
- Operational plan & budgeting
- Plan of dissemination of results
- Biographical information on investigator and institution
I will elaborate some of these things and for more detail can be found in Textbooks and
literature in journals.
Some Components are as follows:
It should be brief and explanatory. Better to include type of study and setting.
Like `A case-control study of risk factors of acute hepatitis B in Karachi`.
Introduction & Background
Relevant details about the problem. The pathophysiology of the disease, global burden,
similar settings and than local (if available)
A description about what other in this field in other countries and in your country has
done. Literature review should be in depth to identify potential cofounders and effect
modifiers and to determine the areas in which knowledge is needed.
It is very important. It should tell that why you want to do this study. Is there any
gap in the existing knowledge that you want to fill? The study has been conducted in other
setting and the finding can be different in your setting (but this is not a good
Study objective and /or research questions
It should identify the immediate purpose of study and be very clear. Objective always
start with `to` (word of accomplishment)
Like `To identify the risk factors of acute hepatitis B in Karachi`
It should include the detail description of methods with reasoning.
Important designs are:
- Randomized controlled clinical trial
- Cohort Study
- Case Control Study
- Cross-sectional Study
- Case series
- Case reports
Details of the designs can be found in any epidemiologic text
Just naming of the design is not sufficient. It should include the details what you
want to do, how you are going to recruit subject, how going to follow etc.
Study population and its recruitment
Description of study population. Inclusion and exclusion criteria (Exclusion
criteria apply after those who are included in study).
Description of the setting whether it is a community or a hospital. In case of
hospital what are the important characteristic of this/these hospital which type of
patient visit this what is its catchment area, how big it is and what diagnostic and
treatment facilities it have. Is it a special centre for some specific disease.
If you are mentioning the field work duration specify it
Sample size determination
How and according to what assumptions sample size is calculated. It is very
important to detect what you intend to do with adequate power.
How sampling will be done; whether is random (type of random sampling) or
convenient sampling. How cases and controls will be identified.
What variables you want to measure.
Methods of data collection
What method you are going to apply as records, questionnaire and in person
interview, mailed questionnaire etc What test you are applying and what is reason for
applying this test. Specificity & sensitivity of the test, if some new test is to be
Plan of Analysis
How you are going to analyze your data. For what you are looking for and which
statistical method will apply.
Whether you run descriptive analysis or go for hypothesis testing and may be
It is better to get help from biostatistician for sample size and data analysis.
Ethical considerations & humane subject protection
This is very important consideration. Now every study should be subjected to ethical
review by Institutional review Board.
Ethical consideration include:
Obligations to study subjects
Protection of their interest. Complete information regarding risk benefit for
participating in any research study is complete right of every subject; no concealment.
Maintaining confidentiality of information obtained from subjects.
Consent form guidelines.
Obligation to society
Avoiding conflict of interest, partiality; communicating finding; data sharing etc.
Obligation to funders or employers
Specifying obligations in contract how research be conducted and it will involve
ethical, technical, administrative or legal responsibilities.
Obligations to colleagues
Promoting and preserving public confidence in epidemiologic research while not over
and under estimating the epidemiologic methods. Disseminating the study findings.
How quality control checks will be introduced and maintained.
Some of the key points are.
- Training of data collector
- Field testing and pilot sties.
- Field editing and final editing
- Data entry mistakes checking etc.
Expected benefits from the study
Who will and how benefit from the study
Operational plan & budgeting
Detail time line and budget for the study
Plan of dissemination of results
How the findings will be shared with others.
By some presentations, publishing results in journal etc.
References should be quoted in Vancouver style.
- Ott MG. Importance of the study protocol in epidemiologic research. J
Occ Med 1991; 33(12): 136-39.
- The Chemical Manufacturers Associationís Epidemiology Task Group. Guidelines for
good epidemiology practices for occupational and environmental epidemiologic research J
Occ Med 1991; 33(12): 1221-29
- Tomenson JA and Paddle GM. Better quality studies through review of protocols J Occ Med
1991; 33(12): 1241-43. .
- Fowkes FGR, Fulton PM. Critical appraisal of published research: introductory
guidelines. BMJ 1991; 302:1136-40.
- International Committee of Medical Journals Editors. Uniform requirements for
manuscripts submitted to biomedical journals. N Eng J Med 1997; 336(4): 309-16.
- Avan BI, White F. Why a research study need a design? JPMA 200;151:197
- World Health Organization. Preparing a Research Project Proposal. Geneva
- Jan W Kuzma. Basic Statistics for Health Sciences. 2nd edition. Mayfield
Publishing Company, Mountain View California 1992.
- Hennekens CH & Buring JE. Epidemiology in Medicine. 1st edition. Little
brown Company USA 1987.
- Friedman LM, Furberg CD, DeMets DL. Fundamental of Clinical Trials. 3rd
Edition. Springer 1998.
- World Health Organization. Operational Guidelines for Ethical Committee that Review
Biomedical Research. WHO Geneva 2000. TDR/PRD/ETHICS/2000.1