SYNOPSIS PROFORMA

Submitted By:

Supervisor:

King Edward Medical University

Lahore – Pakistan
Title of Research Project:

Synopsis Submitted For: Discipline:

MD / MS / MDS Ph. D
M. Phil Research Grant
Name Of The Applicant: D.O.B:

Nationality: NIC #:

Address:

Phone #: Email:

Qualifications (list all; with date of graduation):

Qualification Year Institution

Practical Experience (list all; with dates of employment):

Name of Parent Institution (if on Deputation):

Name of Academic Supervisor / Principal Investigator: Signature: Date:

Name of Co Supervisor / Co-Principal Investigator Signature: Date:

Name of Chairman/ Head of Department Signature: Date:

Name of Principal/ Dean Signature: Date:

Convener, Institutional Review Board Signature: Date:

PROF. DR. SAQIB SAEED

Chairman (Advanced Studies & Research Board) Signature: Date:

Approved Not Approved

Vice Chancellor, KEMU

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. )

NOTE: You must include the reference from institutions own journal (ANNALS of KEMU).
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 King Edward Medical University (to be call
KEMU here after) for which authorization is being granted by the Institutional Review Board
( to be called IRB here after) of KEMU 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 KEMU.
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 prior approval for research project (synopsis) has been obtained from the Institutional
Review Board/ Ethical Committee of my parent institution.
5. That appropriate recognition and acknowledgement shall be given to KEMU 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 KEMU.
6. The aforementioned acknowledgement/recognition shall be mutually decided between the
principal investigator (myself) and the in charge of the unit concerned at KEMU, under
intimation to the IRB of KEMU.

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, KEMU 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.____________________
 Proforma for Evaluation of Research Synopsis
Board of Studies
NOTE: (It should be filled in by All Members of BOS individually)
Title:_________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

A. Must fulfill all of the following.

Sr.No. Essential Criterion No Yes

1. According to prescribed format 
2. Principal Investigator and Co investigator mentioned 
3. Consent form given 
4. Proforma for data collection given 
5. Follow up proforma given 
6. Non-compliance with previous research protocol 
7. Repitition of Study 

B. Kindly evaluate this research proposal and grade the research proposal against
each item. Must get at least 1 in all sections to qualify. Please check the
appropriate box.

Sr. No. Criterion Grading

1. Novelty of research idea 0 1 2 3 4 5
2. Potential for capacity building (Skills) 0 1 2 3 4 5
3. Multidisciplinary 0 1 2 3 4 5
Contribution of research topic
4. 0 1 2 3 4 5
towards public benefit
Contribution of research topic
5. 0 1 2 3 4 5
towards medical knowledge

Total Score 25 Score Obtain

Name:____________________________ Signature: __________________________

 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)
 Investigator’s Brochure and Available Safety
Information for Patient
(Please devise patient information in urdu detailing the complications, if any, and
benefits of the device/ devices and comparison with conventional technique)

 Investigator’s Curriculum Vitae detailing qualification

 Sanctity of Data form - Affidavit duly filled in and signed
 Detailed Visit Forms
(Please make Seperate Proformas for every visit. Keeping in Mind Inclusion and
Exclusion Criteria)
 Minutes of Board Of Studies / Approval of BOS
 Proforma for Evaluation of Research Synopsis filled in individually by members
of the Board of Study
 Soft Copy of Synopsis alongwith soft copy of articles of all
references submit in Research Center on CD.