Annexure No- 3

JORHAT MEDICAL COLLEGE, JORHAT

Form to be filled by the Principal Investigator (PI) for submission to Institutional Ethics Committee (IEC)
(for attachment to each copy of the proposal)

*Code No. of IEC:

* To be filled by IEC Member Secretary

Proposal Title:

To assess the correlation of symptom severity and functional limitation among patients with lumbar
spinal stenosis with neurogenic claudication : A Hospital based observational study.

Name, Designation &

Departmental Tel Nos. Email ID Signature
Qualifications
PRIYANKA KAKATI PH- 7005289500
MASTER OF PHYSIOTHERAPY,
PI 2ndSEMESTER,SSUHS, E-MAIL:
DEPARTMENT OF
PHYSIOTHERAPY(PM&R), JORHAT kakati.priyanka.physio@gmail.com
MEDICAL COLLEGE
Co-PI/ KANGKAN TALUKDAR PH- 9707734607
MASTER OF
Collaborators PHYSIOTHERAPY,LECTURER OF E-MAIL-
PHYSIOTHERAPY,SSUHS, JORHAT
MEDICAL COLLEGE, JORHAT
1. kangkan.physio@gmail.com

2. ARPANA SAIKIA PH- 8638384052

MASTER OF
PHYSIOTHERAPY,LECTURER OF E-MAIL-
PHYSIOTHERAPY,SSUHS, JORHAT
MEDICAL COLLEGE, JORHAT
arpanasaikia564@gmail.com

Please attach Curriculum Vitae of all Investigators (with subject specific publications limited to
previous 5 years). The investigators should sign their CV.
SPONSOR INFORMATION

1. Indian a) Government Central State Institutional

b) Private
2. Interna Government Private UN Agencies
tionl
3. Industr National Multinational
y
4. Contact address of sponsor

5. Budget
Study information
1. Type of study Epidemiological Basic Sciences Behavioral
Clinical Single Centre Multicentric
2. Status New Revised
of review
3. Clinical trials YES No

If YES,
Drug/Vaccines/Device/Herbal Remedies
I. Does the study involve use of
Drugs Devices Vaccines
Indian Systems of Medicines/ Alternate systems Any Other None
of Medicine
II. Is it approved and marketed
In India UK & Europe USA
Other Countries, Specify _____________________________
III. Does it involve a change in use, dosage, route of administration? Yes No
If yes, whether DCGI’s/Any other Regulatory Authority’s Permission is obtained? Yes No
If yes, copy of permission attached Yes No
IV. Is it an Investigational New Drug? Yes No
If yes
a. Investigator’s Brochure enclosed Yes No
b. Preclinical studies data available (If yes, provide summary) Yes No
c. Clinical studies data available (If yes, provide summary) Yes No
d. Clinical study is Phase I Phase II Phase III Phase IV NA
e. DCGI’s permission obtained Yes No
If yes, copy of letter enclosed Yes No
4. Brief description of the proposal-aim(s) and objectives, justification for study, methodology
describing the potential risks and benefits, outcome measures, statistical analysis and
whether it is of national significance with rationale (Attach sheet with maximum 500 words)
5. Subject selection
I. Number of subjects________________
II. Duration of (a) Study:___________ (b) Subject participation(month/years)________________
III. Will subjects from both sexes be recruited Yes No
IV. Inclusion/exclusion criteria given Yes No
V. Type of subjects Volunteers Patients
VI. Vulnerable subjects Yes No
(Tick the appropriate circle)

Pregnant Women Children Elderly

Fetus Illiterate Handicapped

Terminally ill Seriously ill Mentally Challenged

Economically & Any other

socially backward

VII. Special group subjects

(Tick the appropriate circle)

Captives Institutionalized Employees

Students Nurses/Dependent Armed Forces

Any Other Staff

6. Privacy and confidentiality

Direct Identifiers

I. Study Involves
Identifiers/Coded
Completely Anonymised /Delinked
II. Confidential handling of data by staff Yes No
 7. Use of biological/hazardous materials
I. Use of fetal tissue or abortus. If yes provide details Yes No
II. Use of organs or body fluids. If yes provide details Yes No
III. Use of recombinant/gene therapy products If yes, has Department of Biotechnology (DBT) Yes No
approval for rDNA products been obtained?
Yes No
IV. Use of pre-existing/stored/left over samples
Yes No
V. Collection for banking/future research
VI. Use of ionizing radiation/radioisotopes If yes, has Bhabha Atomic Research Centre (BARC) Yes No
approval for Radioactive Isotopes been obtained?
Yes No
VII. Use of Infectious/biohazardous specimens
Yes No
VIII. Proper disposal of material
ix. Will any sample collected from the patients be sent abroad? Yes No
If yes, give details and address of collaborators

a. Sample will be sent abroad because (Tick appropriate circle)

Facility not available in India
Facility in India inaccessible
Facility available but not being accessed
If so, reasons ______________________________________________________________
b. Has necessary clearance been obtained Yes No
8. Consent *Written Oral Audio-Visual

i.Patient Information Sheet attached : (Tick the included elements) Yes No

Understandable language Alternatives to participation
Statement that study involves research Confidentiality of records
Sponsor of study Contact information
Purpose and procedures Statement that consent is voluntary
Risks & discomforts Right to withdraw
Benefits Consent for future use of material biological
Compensation for participation Benefits if any on future commercialization e.g.
Compensation for study related injury Genetic basis for drug development
Translation of information sheet in local
Language
ii. If healthy volunteers will be included, information sheet for them attached Yes No
iii. Consent form in English in local Languages
iv. Who will obtain consent? PI-Co-PI Nurse/ Counsellor
Research Staff Any Other
*If written consent is not obtained, give reasons:

9. Will any advertising be done for recruitment of Subjects? Yes No

(Posters, flyers, brochure, websites – if so attach a copy)
10. Risks & benefits
i. Is the risk reasonable compared to the anticipated benefits to
subjects/community/country? Yes No
ii. Is there physical/social/psychological risk/discomfort? Yes No
If yes, Minimal or no risk
More than minimum risk
High risk

iii. Is there benefit a) to the subject? Yes No

Direct Indirect
b) to the society Yes No
11. Data monitoring
i. Is there a data & safety monitoring committee/Board (DSMB)? Yes No
ii. Is there a plan for reporting of adverse events? Yes No
If yes, reporting will be done to
Sponsor IEC DSMB
iii. Is there a plan for interim analysis of data? ? Yes No
12. Is there compensation for injury?
If yes, by
Sponsor Investigator
Insurance Company Any Other
13. Do you have conflict of interest? Yes No
(Financial/Non financial)
If yes, specify ______________________________________________________________________
Check list for attached documents:
1. Project proposal-5 copies
2. Curriculum Vitae of all Investigators
3. Brief description of proposal/summary
4. Copy of the Protocol/Project and questionnaire (if any)
5. Investigator’s Brochure
6. Copy of Patient information sheet & Consent form in local languages
7. Copy of Advertisements/Information brochures
8. DCGI/DBT/BARC clearance if obtained
9. Copy of Insurance Policy
10. Copy of Clinical trial agreement
11. Copy of IEC proforma
12. Copy of PI undertaking
13. Copy of Case Report Form

Signature of PI

Signature of Head of the Department

 Annexure No-4

Jorhat Medical College, Jorhat

UNDERTAKING BY THE PRINCIPAL INVESTIGATOR

1. NAME AND CODE NUMBER OF THE PROJECT

To assess the correlation of symptom severity and functional limitation among patients with lumbar
spinal stenosis with neurogenic claudication : A Hospital based observational study.

2. NAME, DESIGNATION AND DEPARTMENT OF THE PRINCIPAL INVESTIGATOR

Priyanka Kakati, Master of Physiotherapy, second semester, SSUHS, Jorhat Medical

College, Department of Physiotherapy(PM&R), Jorhat Medical College & Hospital, Jorhat

3. OTHER MEMBERS OF THE RESEARCH TEAM

I. Kangkan Talukdar, Lecturer of Physiotherapy, SSUHS, Jorhat Medical College and

Hospital

II. Arpana Saikia, Lecturer of Physiotherapy, SSUHS, Jorhat Medical College and Hospital

4. NAME AND ADDRESS OF ANY OTHER MEDICAL COLLEGE, HOSPITAL OR INSTITUTION

WHERE PARTS OF THE STUDY WILL BE DONE.

None.

5. NUMBER OF ONGOING PROJECTS/CLINICAL TRIALS IN WHICH YOU ARE PI.

NIL.

1. I confirm that I will initiate the study only after obtaining all regulatory clearances.
2. I will not implement any deviation from the approved protocol without prior consent of the
sponsor nature and it will be intimated to the IEC at the earliest.
3. I confirm that the CO PI and other members of the study team have been informed about
their obligations and are qualified to meet them
4. I will personally supervise the study and ensure that requirements of obtaining informed
consent and other ethical requirements under ICMR and National Regulatory Guidelines are
adhered to.
5. I will maintain accurate and complete record of all cases in accordance with GCP provisions
and make them available for audit/inspection by IEC, Regulatory authorities, Sponsors or
their authorized representatives.
6. I will inform the IEC and the Sponsors of any unexpected or serious adverse event at the
earliest and definitely within seven days of its occurrence.
7. I will maintain confidentiality of the identity of all participating subjects and assure security
and confidentiality of study data.
8. I and my colleagues will comply with statutory obligations, requirements and guidelines
applicable to such clinical studies.
9. I will inform IEC of the date of starting the study within 2 weeks of initiation of the trial and
submit annual progress reports and final report to Member Secretary, IEC within 4 weeks of
the due date.

Signature of Principal Investigator

 Annexure No - 5

ONE PAGE CV
(For Investigators)

Last Name: KAKATI First Name: PRIYANKA Middle Initial

Date of Birth (dd/mm/yy): 01-01-2000 Sex: Female
Study Site Affiliation: JMCH, JORHAT

Professional Mailing Address Study Sited Address

(Include institution name) (Include institution name)

DEPARTMENT OF JORHAT MEDICAL COLLEGE AND

PHYSIOTHERAPY(PM&R), HOSPITAL, JORHAT, ASSAM
JMCH, JORHAT- 785001 785001

Telephone (Office): Mobile Number: 7005289500

Telephone (Residence): E-Mail: kakati.priyanka.physio@gmail.com

Academic Qualifications (Most current qualification first)

Degree/Certificate Year Institution, Country
COLLEGE OF
BACHELOR OF
2022 PHYSIOTHERAPY AND
PHYSIOTHERAPY
MEDICAL SCIENCES, INDIA

Current and Previous 4 Relevant Positions Including Academic Appointments

(Most current position first)
Month and Year Title Institution/Company, Country
DEPARTMENT OF
MASTER OF
PHYSIOTHERAPY, JORHAT
NOVEMBER 2024 PHYSIOTHERAPY
MEDICAL COLLEGE &
STUDENT
HOSPITAL, JORHAT, INDIA
Brief Summary of Relevant Clinical Research Experience:

Signature: Date:

(Signature Required)
 Annexure No - 5

ONE PAGE CV
(For Co-Investigator I)

Last Name: TALUKDAR First Name: KANGKAN Middle Initial

Date of Birth (dd/mm/yy): 25/05/1987 Sex: MALE
Study Site Affiliation: JMCH, JORHAT

Professional Mailing Address Study Sited Address

(Include institution name) (Include institution name)

DEPARTMENT OF PHYSIOTHERAPY(PM&R), JORHAT MEDICAL COLLEGE AND

JMCH, JORHAT- 785001 HOSPITAL, JORHAT, ASSAM
785001

Telephone (Office): Mobile Number: 9707734607

Telephone (Residence): E-Mail: kangkan.physio@gmail.com

Academic Qualifications (Most current qualification first)

Degree/Certificate Year Institution, Country
PhD SCHOLAR(PURSUING) 2021 SSUHS,INDIA
MASTER OF
2012 RGUHS, INDIA
PHYSIOTHERAPY, MPT
BACHELOR OF
2010 RGUHS, INDIA
PHYSIOTHERAPY, BPT
Current and Previous 4 Relevant Positions Including Academic Appointments
(Most current position first)
Month and Year Title Institution/Company, Country
LECTURER OF JORHAT MEDICAL COLLEGE,
JAN’2023- TILL DATE
PHYSIOTHERAPY, SSUHS INDIA
ASSISTANT PROFESSOR OF
AUGUST 2015- DEC’ 2022 RIPT GROUP, INDIA
PHYSIOTHERPY
Brief Summary of Relevant Clinical Research Experience:
AS GUIDE FOR THESIS- PREVALENCE OF RESPIRATORY IMPAIRMENT IN PATIENT WITH
CEREBRO VASCULAR ACCIDENT -A CROSS SECTIONAL STUDY AT TERTIARY CARE
CENTRE,JORHAT, STUDY DURATION -1ST FEB'2024 TO 30TH JULY'2024 FOR 6 MONTHS
AS GUIDE FOR THESIS- A STUDY ON THE EFFICACY OF MUSCLE ENERGY TECHNIQUE IN
FACIAL NERVE PARALYSIS-A CROSS SECTIONAL ANALYTICAL STUDY, STUDY DURATION
- 5TH FEB'2024 TO 1ST AUG'2024 FOR 6 MONTHS

Signature: Date:

(Signature Required)
 Annexure No - 5

ONE PAGE CV
(For Co-Investigator II)

Last Name: SAIKIA First Name: ARPANA Middle Initial

Date of Birth (dd/mm/yy): 23/08/1994 Sex: FEMALE
Study Site Affiliation: JMCH, JORHAT

Professional Mailing Address Study Sited Address

(Include institution name) (Include institution name)

DEPARTMENT OF PHYSIOTHERAPY(PM&R), JORHAT MEDICAL COLLEGE AND

JMCH, JORHAT- 785001 HOSPITAL, JORHAT, ASSAM
785001

Telephone (Office): Mobile Number: 8638384052

Telephone (Residence): E-Mail: arpanasaikia564@gmail.com

Academic Qualifications (Most current qualification first)
Degree/Certificate Year Institution, Country
MASTER OF ASIAN INSTITUTE OF PUBLIC
2022
PHYSIOTHERAPY, MPT HEALTH, INDIA
BACHELOR OF DOWN TOWN UNIVERSITY,
2019
PHYSIOTHERAPY, BPT INDIA
Current and Previous 4 Relevant Positions Including Academic Appointments
(Most current position first)
Month and Year Title Institution/Company, Country
LECTURER OF JORHAT MEDICAL COLLEGE,
MAR’2025 - TILL DATE
PHYSIOTHERAPY, SSUHS INDIA
ASSISTANT PROFESSOR OF NEPNI College of Allied Health
DEC’ 2022- MAR’2025
PHYSIOTHERPY Sciences, INDIA
Brief Summary of Relevant Clinical Research Experience:

Signature: Date:

(Signature Required)
 Annexure No - 7

JORHAT MEDICAL COLLEGE, JORHAT

INTIMATION OF START OF STUDY

1. Project/Trial Code Number

2. Title of the drug/multicentric trial

3. Principal Investigator (Name &

Department)

4. Sponsor

5. Contract Research Organization (CRO) if

any

6. Date of sanction by IEC

7. Date of start

(Signature of Principal Investigator)

Date _________________________
 Annexure No- 8

JORHAT MEDICAL COLLEGE, JORHAT

PROGRESS REPORT (ANNUAL)/FINAL REPORT

1. Project/Trial Code Number

2. Title of the drug/multicentric trial
3. Principal Investigator (Name & Department)
4. Sponsor
5. Contract Research Organization (CRO) if
any
6. Date of sanction by IEC
7. Date of start
8. Objectives of the study
9. Progress report as per objectives (attach
separate sheet)
10. Serious Adverse Events if any with details (in
summary form)
11. Protocol deviation if any with
reasons/justifications
12. Report/publications/conference presentation
13. Awards/recognition

Date:
(Signature of Principal Investigator)

(Signature of Head of the Department)

 Annexure No -9

Jorhat Medical College, Jorhat

GUIDELINES FOR PATIENT INFORMATION SHEET

1. Study Title

To assess the correlation of symptom severity and functional limitation among patients with lumbar spinal
stenosis with neurogenic claudication : A Hospital based observational study.

2. Invitation Paragraph

You are invited to take part in our study, “To assess the correlation of symptom severity and functional
limitation among patients with lumbar spinal stenosis with neurogenic claudication : A Hospital based
observational study”, conducted at Jorhat Medical College & Hospital, Jorhat..
Before you decide, you can talk to anyone you feel comfortable with regarding the research. If you have
any questions or doubt about the study, or if you would like more information, please don’t hesitate to
reach out to us. Take your time to consider whether or not you wish to take part in the study.

3. What is the purpose of the study?

To understand the relationship of associated functional limitation and symptomatology of lumbar spinal
stenosis with neurogenic claudication.

4. Why have I been chosen?

You have been chosen for this study because you meet the specific criteria and characteristics that are
relevant to our research objectives.

5. Do I have to take part?

Participation in this study is entirely voluntary. You are under no obligation to take part, and your decision
to participate or not will be entirely respected. We encourage you to carefully consider whether you wish
to be involved in the study.
6. What will happen to me if I take part?

If you decide to participate in this study, you can expect a thorough assessment of symptom severity and
functional limitation. Your data will be collected and kept confidential to contribute to our understanding
of correlation of symptom severity and functional limitation with neurogenic claudication in non-operative
patients with lumbar spinal stenosis.

7. What do I have to do?

Your role in this study will primarily involve participating in comprehensive assessment of
symptomatology and functional limitation.

8. What is the drug or procedure that is being tested?

Not applicable.

9. What are the alternatives for diagnosis or treatment?

NIL.

10. What are the side effects of taking part?

There are no side effects of taking part in this study.

11. What are the possible disadvantages and risks of taking part?

There are no possible disadvantage or risks in any way during the study.

12. What are the possible benefits of taking part?

The benefits of taking part in this study will be performance enhancement. .

13. What if new information becomes available?

If additional information becomes available during the course of study, the research participants will be
informed about it.

14. What happens when the research/trial study stops?

If the treatment will not be available after the research/trial finishes this should be explained to the patient.
You should also explain to them what treatment will be available instead. Occasionally the company
sponsoring the research/trial may stop it. If this is the case the reasons should be explained to the patient.

15. What if something goes wrong?

Since there are no associated risks, there is no possibility of anything going wrong during your
participation.

.
16. Will my taking part in this study be kept confidential?

Yes.

17. What will happen to the results of the research/trial study?

The research process will undergo analysis, and if deemed necessary, the study will be published while
ensuring the complete confidentiality and anonymity of all participants with no personal identities
disclosed.

18. Who is organizing and funding the research/trial?

Self.

19. Who has reviewed the study?

The Institutional Ethical committee, Jorhat Medical College & Hospital has reviewed and approved the
study.

20. Contact for further information

Name of PI: Priyanka Kakati

Student of Master of Physiotherapy
Department of Physiotherapy (PM&R)
Jorhat Medical College, Jorhat
Ph- 7005289500
.

Signature of PI

Date
 Annexure No - 10

JORHAT MEDICAL COLLEGE, JORHAT

INFORMED CONSENT FORM

 Study Title: To assess the correlation of symptom severity and functional

limitation among patients with lumbar spinal stenosis with
neurogenic claudication : A Hospital based observational study
 Study Number:
 Subject’s Full Name:
 Date of Birth:  Age:
 Address:
 Study Title:
 Study Number:
 Subject’s Full Name:

1. I confirm that I have read and understood the information sheet dated_________ for the above study and
have had the opportunity to ask questions.

OR I have been explained the nature of the study by the Investigator and had the opportunity to ask
questions.

2. I understand that my participation in the study is voluntary and that I am free to withdraw at any time,
without giving any reason and without my medical care or legal rights being affected.

3. I understand that the sponsor of the clinical trial/project, others working on the Sponsor’s behalf, the
Ethics Committee and the regulatory authorities will not need my permission to look at my health records
both in respect of the current study and any further research that may be conducted in relation to it, even if
I withdraw from the trial. However, I understand that my Identity will not be revealed in any information
released to third parties or published.

4. I agree not to restrict the use of any data or results that arise from this study provided such a use is only for
scientific purpose(s)

5. I agree to take part in the above study

 Signature (or Thumb impression) of

the Subject/Legally Date:
 Acceptable Representative:
 Signatory’s Name Date:
 Signature of the Investigator Date:
 Study Investigator’s Name Date:
 Signature of the Witness Date:
 Name of the Witness
 Annexure No – 11

Jorhat Medical College, Jorhat

SECRECY UNDERTAKING BY MEMBER OF INSTITUTIONAL ETHICS

COMMITTEE

 Name:
 Designation:
 Address:

I understand that as a Member of the Institutional Ethics Committee I may receive documents containing
confidential or privileged information about patients, volunteers or commercial products.

I agree not to disclose or discuss such information or minutes of the meeting with persons not entitled to
have them. I also agree either to return all documents marked CONFIDENTIAL/PRIVILEGED to
Member Secretary or destroy them after perusal.

Signature Date
 PROFORMA

DEMOGRAPHIC DETAILS

Name:

Age:

Sex:

Dominance :

Time period since onset of Neurogenic claudication:

Occupation:

Address:

HISTORY

Present history:

Past history:

Surgical history:

Examination

Investigation

Diagnostic interpretation according to CT scan or MRI

Background variables:

 Score of Swiss spinal stenosis questionnaire

 Score of Oswestry disbality index

SIGNATURE OF THE INVESTIGATOR:

DATE:
 BRIEF DESCRIPTION OF THE STUDY PROPOSAL

Name: Priyanka Kakati

Designation: Master of Physiotherapy, 2nd semester

Affiliation: Srimanta Sankaradeva University of Health Sciences, Guwahati, Assam

Study Title To assess the correlation of symptom severity and functional

limitation among patients with lumbar spinal stenosis with neurogenic
claudication : A Hospital based observational study.

Purpose To evaluate the correlation of symptom severity and functional

limitation among non-operative patients with LSS with neurogenic
claudication.
Aim & Objectives Aim :
To evaluate the correlation of symptom severity and functional limitation in
non-operative patients with Lumbar Spinal Stenosis.

Objectives:
1. To determine the prevalence of symptom severity in non-operative
patients diagnosed with Lumbar Spinal Stenosis with neurogenic
claudication
2. To evaluate the extent of functional limitation in this population.
3. To analyse the relationship between symptom severity and functional
impairment in this population.

Hypothesis Alternative Hypothesis:

There is a significant relationship between symptom severity and functional
limitation with neurogenic claudication in non-operative individuals with
Lumbar Spinal Stenosis.

Null Hypothesis:
There is no significant relationship between symptom severity and
functional limitation with neurogenic claudication in non-operative
individuals with Lumbar Spinal Stenosis.

Methodology The study will involve 80 participants from Neurosurgery and PMR
department of Jorhat Medical Collage And Hospital, Jorhat. On the
day of evaluation, subjects will be assessed for symptom severity and
 functional limitation with swiss spinal stenosis questionnaire and
Oswestry disability index,respectively The response will be obtained
and analysed using SPSS software.

Analysis Data will be analysed by using SPSS software

Outcome measures swiss spinal stenosis questionnaire and Oswestry disability index.

SIGNATURE OF CO-INVESTIGATOR SIGNATURE OF PRINCIPAL INVESTIGATOR