PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India

Phone: +91-0422-4345818. Fax: +91-422-2594400

SOP 03-V 4 / ANX 02-V 4.2

Institutional Human Ethics Committee
E-mail: [email protected]

Study Protocol Submission Form (Other than Regulatory Trials)

(Two hard copies and one soft copy to be sent to the IHEC Secretariat)

1. IHEC PSG IMS&R Study Proposal No. (to

be assigned by IHEC Secretariat)
2. Title of the Study:

“COMPARING THE EFFECTIVENESS OF ISOTONIC CORE

STABILIZATION AND GLOBAL POSTURAL RE-EDUCATION ON PAIN,
FUNCTIONAL DISABILITY, AND RANGE OF MOTION IN SUBJECTS WITH
NON- SPECIFIC CHRONIC LOW BACK PAIN”.

3. Name, affiliation and qualifications of the research investigators

Role in the
Sl. Name of the Investigators Institution Department Qualifications (with
proposed
No. (starting with PI) al ID No. & Institution subject)
study*
MS.SRISUBHIKSHA.S 24MP009 PSG COP MPT A,B,C,D,E,F,I,
(i) (STUDENT) J,K,L,M,N,O,P
,Q,R,S
PROF.MAHESH.R 1602 PSG COP MPT( CARDIO- A,B,C,K,N,O,
(ii)
RESPIRATORY) Q
PROF.ASHRAF.Y 5919 PSG COP MPT A,B,C,D,E,I,J,
(iii ) ( ORTHOPEDICS) K,L,M,N,O,P,
Q,R,S
DR.DINAKAR RAI B.K 201652 PSGIMSR & MS C,G,H,I,J,K,L.
(iv) HOSPITALS (ORTHOPEDICS)

DR.RAMAMOORTHY.V 1167 PSGIMSR& MD,DNB(PMR) C,G,H,I,J,K,L.

(v)
HOSPITALS
* Roles and responsibilities of investigators: choose the appropriate codes (A to T) below and write
them against their name in the appropriate column above.
K. SAE evaluation and reporting
A. Concept L. Examination of patients on follow-up
B. Design M. Data collection and monitoring of data
C. Screening of patients N. Interpretation of data
D. Selection and recruitment of study participants O. Statistical analysis & Interpretation
E. Informed consent P. Maintaining patients file and master file of project
F. Selection & Recruitment of patients Q. Drafting final report
G. Laboratory investigations R. Submission of final report to funding agency and
H. Laboratory report interpretation IHEC
I. Treatment decision S. Publication
J. Patient evaluation T. Any other, please specify

4. Contact Information of the Principal Investigator (corresponding investigator)

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 PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India
Phone: +91-0422-4345818. Fax: +91-422-2594400

4a. Mobile Number 9361450491

4b. Department Phone Extension Number 044-4345871

E= I = Intramural Funding
5. Grouping: S = Self-funded
Extramural (PSG IMS&R funded)
Tick () all that are applicable Funding
6. If funded, contact Address of Sponsor: (non-PSG
IMS&R
NOT APPLICABLE funded)

7. Clinical Trials: Yes / Not Applicable

If Yes does the study involve use of :

Drug Devices Vaccine Alternate Any Other
ystem of (specify):
Medicine
i. Is it approved and marketed
India Other countries (specify):
in:
8. Please attach the description of the proposal including following details: (Please attach a separate
sheet)
 Introduction
 Review of literature
 Justification for study
 Aim(s) & objectives
 Study design
 Study population ATTACHED
 Sample size and its justification
 Inclusion / exclusion criteria
 Methodology (with flow-chart)
 Storage & disposal procedures of biological / hazardous material (if needed for your project)
 Potential risks & benefits
 Statistical analysis
 Itemized budget
 References
9. Duration of study 10 MONTHS
10. Consent :
10 (a) Written consent form should include the following details:
Understandable language (English & local)  Alternatives to participation 
Statement that study involves research  Confidentiality of records 
Consent for future use of biological material,
Sponsor of study, if applicable
if applicable
Purpose and procedures  Statement that consent is voluntary 
Risks & Discomforts  Right to withdraw 
Benefits  Contact information of PI and IHEC 
10(b) Who will
PI / Co-PI Research Staff Nurse / Counselor Other (Specify)
obtain the consent?

10 (c) If consent is not applicable to your research project / study,

please submit a waiver of consent application form and confidentiality statement to IHEC

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 PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India
Phone: +91-0422-4345818. Fax: +91-422-2594400

11.Conflict of Interest
(i) Do you have conflict of interest?
(financial/nonfinancial) Yes  No
(ii) If Yes, specify :
12. Storage and archival of study documents
Specify the period and site of storage of study documents:
3 YEARS , PSG COLLEGE OF PHYSIOTHERAPY

13. Dissemination of study result

Peer-reviewed scientific journals 
Conference presentation 
Proposal plan for reporting and Internal report 
dissemination of study results Submission to regulatory authorities 
Access to raw data and right to publish freely by all the
(Tick [] all that are applicable) investigators in study or by independent steering committee
on behalf of all investigators
Other ………………..

14. Permission to collect data from departments (attach permission letters in separate sheet).
Write below the names of departments and institutions from where samples are to be collected.
It is the responsibility of the PI to obtain permission from each and every department of PSG IMS&R
involved in data collection (and heads of departments as well as institutions, if samples are collected and/or
diagnostic or imaging services are used from the respective departments / institutions) by furnishing all
necessary information (including purpose, sample size, cost involved, etc., to the heads of the departments
concerned).

ATTACHED

15. Permission to carry out the study elsewhere (outside PSG IMS&R): Yes / No / NA
If study will be conducted fully or partially outside the PSG IMS&R, please describe the need,
permission from institution(s), health centre(s), local government/administrative bodies, etc.
Attach permission letters obtained already, if any.

NOT APPLICABLE

16. Checklist of documents to be submitted with the Study Protocol Submission Form
Item Description Yes No NA
1. Covering Letter 

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 PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India
Phone: +91-0422-4345818. Fax: +91-422-2594400

2. Brief description of proposal (Study Protocol) 

3. Informed Consent form (in English) 

4. Informed Consent form (in all relevant regional


languages)
5. Waiver of consent 
6. Confidentiality agreement signed by ALL

investigators
7. Copy of questionnaire (in English) 
8. Copy of questionnaire, translated version (in all

relevant regional languages)
9. Copy of Case Report Form (In English) 
10. Copy of Case Report Form, translated version (in

all relevant regional languages)
11. Copy of Data collection tool (In English) 

12. Copy of Data collection tool, translated version (in


all relevant regional languages)

13 Advertisements or recruitment documents, if any 

14. Permission letter(s) from heads of departments other

than that of the PI, if study involves data collection / uses

diagnostic and/or imaging services from those
departments of PSG IMS&R

15. Memorandum of Understanding

16. Clinical Trial Agreement

17. Authorship Agreement 

18. DCGI Approval

19. CTRI Number

20. CV of ALL Investigators (including Guide) 

21. Other (specify):



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 PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India
Phone: +91-0422-4345818. Fax: +91-422-2594400

17. Signature of PI
Undertaking:
I hereby agree to abide by the ethical principles set out in relevant guidelines.
I hereby declare that contents of the soft and hard copies of this document submitted to the IHEC are the
same.

Name: MS. SRISUBHIKSHA .S

Designation, Department & Name of the Institution: MPT I YEAR ( STUDENT)

PSG COLLEGE OF PHYSIOTHERAPY
COIMBATORE.

Date: Signature of PI

17.a. Signature of co-investigators

S No. Name Designation Institution Signature
i. PROF. MAHESH .R PRINCIPAL PSG COP

ii. PROF.ASHRAF.Y PROFESSOR PSG COP

iii. DR. DINAKAR RAI B.K HOD DEPARTMENT PSGIMSR &

OF ORTHOPEDICS HOSPITALS

iv. DR .RAMAMOORTHY.V HOD DEPARTMENT PSGIMSR &

OF PMR HOSPITALS

18. Name and Signature of the Research Guide

I have reviewed this project proposal and consent to guide this project.

Name of the Guide: PROF.ASHRAF.Y

Designation, Department & Name of the Institution: MPT ( ORTHOPEDICS),

PROFESSOR,
PSG COLLEGE OF PHYSIOTHERAPY,
COIMBATORE.

Date: Signature of the Guide

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 PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore 641 004, India
Phone: +91-0422-4345818. Fax: +91-422-2594400

19. Forwarded by the Head of PI’s Department

I am forwarding the above project submitted by SRISUBHIKSHA.S Principal Investigator from my

Department. I endorse the project and have ‘no objection’ for submission for consideration by the
IHEC, PSG IMS&R.
I concur with the participants / investigators included in the study.

The department has adequate facilities to carry out this study.

The investigators are permitted to use the facilities available in this department to carry
out the study.

Name of the Head of the Department: PROF.MAHESH.R

PRINCIPAL
PSG COLLEGE OF PHYSIOTHERAPY
COIMBATORE.

Signature of the Head of the Department with date:

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