SRM MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE

SRM Nagar, Kattankulathur, Potheri- 603023.

CHECK LIST
SNO CHECKLIST QUESTIONS
YES
1
FORMAT
Title with complete details of principal investigator & co investigators
Covering letter with approval of HOD & Dean
Statistician approval
A4 double space Times new Roman font of size 12
2
TITLE
Is it meaningful?
Does it reflect study nature & Purpose?
Is it inconclusive or unbiased?
Is the type of study stated explicitly?
3
STUDY JUSTIFICATION
What this study intends / Expected to add to our knowledge?
4
HYPOTHESIS
Is it clearly stated?
Logic of Hypothesis
Is it testable?
5
AIMS & OBJECTIVES
Are they been stated clearly?
Are they coherent with title & study design?
6
REVIEW OF LITERATURE
Is the deficiency of existing knowledge stated?
7
STUDY DESIGN, VARIABLES & PARAMETERS (To be
checked by statistician)
Is the setting defined?
Is the study duration clearly stated?
Is the study type stated clearly?
Are the study variables listed & defined?
Are the study parameters listed & defined?
How are the variables controlled?
8
SAMPLE SIZE (To be checked by statistician)
Is it decided following statistical principles?
Was it calculated with power of the study?
Is the sample size & study power sufficient to address the hypothesis?
9
STATISTICAL METHODS (To be checked by statistician)
Are statistical methods clearly stated for each type of parameters /
variables?
Is the P value defined?
Have they stated the reason for accepting or error?
Is the software to be used is mentioned?
10
FUNDING
Source of funding ( Self/ Govt./Pharma companies etc)
If funded my commercial companies who owns & controls the data?
11
ANCILLARY SERVICES

NO

12

13

14

15

16

17

Are the services of ancillary department needed?

If yes, is the necessary permission obtained?
Does the contribution of ancillary services satisfy / deserve authorship
criteria?
DATA COLLECTION
Names of people involved in data collection
Are they pre-trained to collect data?
Do they receive any remuneration? ( esp. for extra mural projects)
REFERENCES
Are they >10?
Do they comply with Vancouver / Harvard style?
Is 50% of references <10 years?
CONFLICTS OF INTEREST
Does the study involve any products manufactured distributed / sold
by finding body / company
Has the researcher / guide / co-guide benefited by any means by the
manufacturer/seller of product tested
Are the study subjects shared by another ongoing study if so,
justification to include them in this study
INTERVENTION
If it is an interventional study has the nature of intervention
described?
List of potential / actual harm arising out of the intervention
Are the steps to be taken for reducing harmful effects mentioned?
Is there any compensation for adverse effects?
PRODUCT USED IN THE STUDY
Is it already in use?
If yes, is the purpose same as that of the study?
If no, are any animal studies available?
How the product is differently used in the study than it is currently
used in clinical setting?
Is the product side effects already studied?
Is there an advisory against the product by FDI / DCI?
ETHICS
Does this study require ethical clearance?
Has the consent form in English / vernacular language included?
If study involves subjects <18 years of age, is child ascent form
included?
If it means lab animals, is clearance obtained from lab veterinarian?

Signature of the Principal investigator/ Guide

Signature of the statistician