SYNOPSIS
Submitted By:
Supervisor:
Dr. Ghulam Mujtaba Nasir
Assistant Professor – Community Medicine
Nishtar Medical University
Multan – Pakistan
TITLE: (Start From New Page)
( Title Should reflect the objectives of the study. It must be written after the whole synopsis has
been written so that it is a true representative of the plan i.e. the synopsis )
INTRODUCTION: (Start From New Page)
( Introduction should contain brief background of the selected topic. It must identify the
importance of study. Its relevance and applicability of results. It must clearly state the purpose
of the study. It should not exceed 500 words. )
OBJECTIVES: (Start From New Page)
( Objectives are statements of mentions. They inform the reader clearly what the researcher
plans to do in his/her work. They must identify the variables involved in research.
Objective should start with an action verb and be sufficiently specific, measurable, achievable,
relevant and time bound (SMART). )
OPERATIONAL DEFINITION: (Start From New Page)
( It is definition of a term specifically telling how it will be measured e.g.:
I. Morbidity: this encompass a number of aspects viz. prolonged hospital stay, severe
pain, immediate complications, long term sequelae.
A researcher must define how a vague term will be measured.
II. Efficacy: These can be measured:
i. Time taken in relief of symptoms which may be pain, fever, cough, heartburn
etc.
ii. Taking into account number of side effects.
iii. Time taken for complete recovery
Student is requirement to specify how he/she will measure efficacy. )
HYPOTHESIS: (Start From New Page)
(A hypothesis is a statement showing expected relation between 2 variables. A hypothesis is
needed in the following study designs:
i. All interventional studies
ii. Cohort
iii. Case Control
iv. Comparative Cross Sectional )
MATERIAL AND METHODS: (Start From New Page)
( STUDY DESIGN: Mention the name of the appropriate study design.
SETTING: Name and place where the research work is to be conducted.
DURATION OF STUDY: How long will the study take with dates?
SAMPLE SIZE: How many patients will be included. If there are groups, how many
per group?
SAMPLING TECHNIQUE: Type of sampling technique employed.
SAMPLE SELECTION:
Inclusion Criteria: On what basis will patients be inducted in the study.
Exclusion Criteria: On what basis will patients be excluded from the study.
DATA COLLECTION PROCEDURE: A detailed account of how the researcher will
perform research; how he/she will measure the variable.
It includes: Identification of the study variables
Methods For Collection of Data
Data Collection Tools (Proforma/Questionnaire)
DATA ANALYSIS PRODECURE: Relevant details naming software to be used, which
descriptive statistics and which test of significance if and when required, specifying
variables where it will be applied. )
OUTCOME & UTILIZATION: (Start From New Page)
( Describe in which way the expected results of your study can be useful in designing
and delivery of health care system: )
SCHEDULE/PHASING: (Start From New Page)
( In order to achieve the desired objectives of the study, divide your work plan into
different phases in a tabular form. )
REFERENCES: (Start From New Page)
( In Vancouver style
Examples:
JOURNAL
Haas AN, de Castro GD, Moreno T, Susin C, Albandar JM, Oppermann RV, et al. Azithromycin
as a adjunctive treatment of aggressive periodontitis: 12-months randomized clinical trial. J Clin
Periodontol. 2008 Aug; 35(8):696-704.
BOOK
Mason J. Concepts in dental public health. Philadelphia: Lippincott Williams & Wilkins; 2005. )
DATA COLLECTION INSTRUMENT: (Start From New Page)
(The researcher must attach, as an annex, the proforma or questionnaire with the
help of which he/she intends to collect data. The proforma/questionnaire must
match the objectives and must not contain irrelevant sections like inclusion and
exclusion criteria etc. Add sample scheduled visit proforma. )
Sanctity of data - Affidavit
I,Mr/Ms_________________________________________________S/o_________________________
Student of___________________________________________________________________________
working in _____________________________
Under Supervisorship of __________________________________
Hereby undertake to abide by the following rules
1. That the data collected during my attachment at Nishtar Medical University (to be call
NMU here after) for which authorization is being granted by the Institutional Review
Board ( to be called IRB here after) of NMU for which I have submitted my synopsis
titled__________________________________________________________________________
______________________________________________ shall be used exclusively for the
purpose of “not for profit” research and will not use for any other purpose what so ever.
Any financial gain or patent originating from this research shall be equally shared with
NMU.
2. The data collected shall be strictly limited to the parameters defined in my synopsis titled
______________________________________________________________________________
_____________________________________________
3. That the identity of patients (cases) shall not be revealed.
4. That appropriate recognition and acknowledgement shall be given to NMU in the
publication of the paper/papers or any other medium of communication what so ever, if it
utilizes the data/ graphs/tables/pictures collected from the aforementioned research,
furthermore, in any subsequent publication or any other medium of communication what
so ever, if it utilizes the above mentioned data/graphs/tables/pictures with proper
acknowledgement (as mentioned below) and with prior intimation and authorization of IRB
of NMU.
5. The aforementioned acknowledgement/recognition shall be mutually decided between the
principal investigator (myself) and the in charge of the unit concerned at NMU, under
intimation to the IRB of NMU.
I have read all the clauses of the above written agreement and hereby agree to be legally bound to
this agreement in letter and spirit. I also understand that if I am in breach of this contract; I shall
lose the right to the data/publication/graphs/tables collected/published (stored in any form
physical/electronic) thereof. In addition, NMU will reserve the right to initiate proceedings against
me at any/all for a deemed appropriate. Research Supervisor (as shown below) shall stand witness
and guarantor of this agreement and would be equally liable in case of breech of agreement.
Signature (Principal Investigator) Signature of Supervisor
NIC No.____________________ NIC No.____________________
List of Required Documents For Approval of
Institutional Review Board
Informed Consent Form in English and Urdu
Subject Recruitment Procedure
(e.g OPD, Indoor, Advetisement)
Copy of Synopsis
