SRM MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE

SRM Nagar, Kattankulathur, Potheri- 603023.

CHECK LIST

SNO CHECKLIST QUESTIONS YES NO

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 α or β 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

Are the services of ancillary department needed?

If yes, is the necessary permission obtained?

Does the contribution of ancillary services satisfy / deserve authorship

criteria?

12 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)

13 REFERENCES

Are they >10?

Do they comply with Vancouver / Harvard style?

Is 50% of references <10 years?

14 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

15 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?

16 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?

17 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