Malabar CancerCentre ANX1-VER1/SOP03/VER1

RESEARCH PROJECT PROTOCOL FORM

Institutional Review Board (IRB)
Malabar Cancer Centre (MCC), Thalassery - 670103, India.

(A) GROUPING OF RESEARCH PROJECT

Project No.
(For Office Use Only)

Project Title

1
Name of the Principal 2
Investigator (PI)
3

Please complete the questionnaire for submitting the research proposal for IRB- MCC
Study Group
(Please fill up the applicable Yes(Y)/No(N) neatly)

Group Detail Yes/ No

Controlled Trials
01. A1 a Is this a Randomized Controlled trial?
02 A1 b Is this a Non-Randomized Controlled trial?
03 A1 c
Is this a controlled trial that seeks new indication for establishing
drug, process or a procedure?
Uncontrolled Trials
Is this a prospective trial testing new intervention, drug, or device
04 A2 a
on patients?
Is this a prospective trial designed to test new (unproven)
05 A2 b indication for established drug, process, procedure or device on
patients?
Is this a pilot trial on new intervention, drug, and device on
06 A2 c
patients?

07 A3 a Is this a Multi-centre trial?

Is this trial involves transfer of patients’ data to another site
08 A3 b (including industry)?

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Is this trial involves transfer of patients’ blood, serum, DNA, tissue
09 A3 c
to another site?

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10 A4 a Are you seeking Intramural funding?

Does this trial use additional resources of MCC beyond the usual
11 A4 b work-up (e.g., Molecular profiling, MRI or any other non- routine
part of work-up)

Are you submitting application for extra-mural grant for this trial?
12 A5 a
Is this trial partly or wholly supported by grants from sponsored
13 A5 b
industry?
Is this a phase IV/ marketing trial undertaken on behalf of the
14 A5 c
industry?

Are you seeking modifications in the IRB-MCC approvedtrial?

15 A6

Are patient going to bear the cost of experimental intervention or

16 A7 a drug therapy?

Does patient has to undergo additional blood sample collection,

17 A7 b biopsy, endoscopy, procedure etc.?

Whether the patient has to bear the cost of complications arising

18 A7 c from experimental treatment?

For the trial purpose, does the patient has to spend Rs. 5000/- or
more above the usual expenses (for any reason such as drug
19 A7 d
therapy, additional investigation, prolonged stay or repeated
travel)?

Will the trial be undertaken in the community?

20 A8 a
Will the trial involve screening?
21 A8 b

Does this trial involve conducting Genomics or Proteomics studies

22 A9 on patients’ specimens?

Will this trial involve development of a device, drug or test lead to

23 A10 profits or patent?

Is this a prospective follow-up study (documentation of parameters

24 B1 only) of patients being offered standard treatment at MCC?

Is this a phase II-IV trial restricted to standard intervention/

25 B2 treatments?

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Is this a feasibility study for introduction of new treatment,

recently shown in major international studies, to be beneficial /
26 B3
superior and need to be started at MCC?

Is this a retrospective or prospective analysis of charts and audit of

B4 procedures / tests / treatments?
27
Is this a retrospective or prospective review of pathology specimen
(may involve some additional staining techniques)?
28 B5

Is this a retrospective or prospective review of radiology reports

29 B6 and their clinical correlation?

Is this a retrospective or prospective review of laboratory reports

30 B7 and their clinical correlation?

Procedure / demonstration at workshops etc.

Are you demonstrating an experimental procedure which is ‘not
31 B8 established standards of care’ at a workshop or a public meeting?

Are you performing a procedure in workshop at MCC by non-

32 B9 MCC staff member? (Please check other requirements also)

NameofPI(s) Signature withDate

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Project Submission Form for review by IRB, MCC

(B) PROJECT FACTSHEET

1. Study/Project Number(to be filled

up by IRB Office, MCC)

2. Project Title

3. Date of receipt by IRB, MCC

4. Keywords for Title (2 to 4 options)

1
5. Principal Investigator(s) 2
3
4
6. Number of ongoing study the PI is Zero
involved (as PI only)
7. Full address & Contact details of
PI
(provide e-mail ID & contact no.
along with complete mailing address
in CAPITAL LETTERS)

8. Co-Investigator(s) 1
2
3
4
5
6
7
9. Name of the Study Site

10. Agency or Sponsor or Funding

resource

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11. Total estimated Budget (in Rs.)

12. Duration of the project (in months)
13. Total number of patients to be
accrued in study (including MCC, if
multi-institutional study)

14. Expected Date/Month of starting

the project
15. Will biological products be sent out
of the country? (Yes/No)
If yes, attached the copy of regulatory
clearance obtained [DCGI/ ICMR
/Health Ministry Screening Committee
(HMSC)]

16. Any Conflict of interest, (Yes/No)

If Yes Please specify

------------------------------------------------------
Signature of PI Date (dd/mm/yyyy)

InvestigatorsDeclaration:

1. This research project (including collection of blood or tissues samples for research) will not be
started until the final approval of the IRB has beenobtained.
2. We agree to undertake research proposal involving human subjects in accordance with the ICH-
GCP and ICMR ethical guidelines, 2006. We will not modify the research protocol, consent, etc
without prior approval by theIRB.
3. The investigators agree to obtain a properly informed and understood consent for all trial subjects
before their inclusion in the trial in the informed consent form that is approved by the IRB.
Participants will receive an ‘information sheet’ which will detail the project design in simple
understandable layperson’slanguage.
4. The investigators agree to report within a week all serious adverse events (SAE) associated with the
trial in the SAE form to the IRB. In the event of a death of the trial subject, the Secretary, IRB and
DSMSC, will be informed within 24hours.
5. The investigators agree to submit periodic 6 monthly progress report of the trial in the appropriate
form. A final report will be submitted at the end of thetrial.
6. Full details on funding and a proposed budget are included with the trial proposal. The proposed
budget is presented on the specific budget sheet of thisform.
7. We understand that the IRB is concerned about transparent financial transactions during the trial.
A report on how the trial funds were utilized will be presented to the Academic Council of MCC
along with the final project report at the end of thetrial.

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8. The investigators agree to transfer 15% of the total budget to MCC as service charges. This will
not apply to intramural projects, those projects cosponsored by MCC/MOHFW-DHR and
ICMR/CSIR-CDRI/ DBT /DST/WHO/BARC/UGC fundedprojects.
9. The investigators agree that the grant money will be spent in accordance with the budget
proposal only. The funds will not used for any other purposes without prior approval from the IRB.
Thirty percent of the surplus grant if left over at the end of the study will be credited to MCC. The
remaining 70% of the surplus grant money may be used by the investigators for conducting
intramural research, improving teaching facilities in the department, providing financial assistance
to investigators for conferences, etc after obtaining permission from the MCCauthority.
10. For all research proposals that are sponsored by a pharmaceutical or biomedical company, we the
investigators will ensure that the Sponsor Company will underwrite all expenses such that neither
the hospital nor the study participants are made to spend while participating in the trial. The
investigators will also ensure that in the event of complications arising directly due to the trial
orlitigation,thecostofmanagementorlegalfeeswillbebornebytheSponsorCompanytotally.
11. The investigators state that they do not stand to gain financially from the commercial sponsor and
donothaveconflictofinterestinthedrugorproductbywayofconsultations,shareholding,etc.
12. The investigators will ensure that personnel performing this study are qualified, appropriately
trained and will adhere to the provisions of the Institutional Ethics Committee (IEC). MCC,
approvedprotocol.
13. All data collected during the research project, including those supported by commercial sponsors
(e.g. pharmaceutical company), will remain the property of Malabar CancerCentre.
14. The salaries to staff employed for the research project will be as shown in the budget sheet and
at par with the prevailing MCC salaryscales.
15. The case records (source documents) will be made available to members of the SRC of IRB any
time for random verification and monitoring. The case records (source documents) will be
preserved in the premises of MCC for at least 5 years after the last approval of application or
publication.
16. The investigators promise to ensure that there is no falsification of data when compared to the
source documents. We agree to clarify any doubts or discrepancies that may arise during the
data monitoringevaluation.
17. All the findings and conclusions of the proposed project such as review of case records, analysis of
forms of treatment, investigations, etc will be first presented to the staff members of MCC before
they are released or presented elsewhere. The investigators will submit a copy of the abstract to the
SRC and IRB well in advance of any proposed presentation at national or international conferences
orseminars.
18. The investigators will not issue any press release before the data and conclusions have been peer-
reviewed by the MCC staff or published in a peer-reviewedjournal.
19. All serious injuries arising from the trial will be the responsibility of the Investigators. The
investigators agree to ensure that the sponsors undertake a product liability insurance to cover
any expenses for injury or compensation arising from the studytreatment.
20. The investigators will constantly inform the IRB about amendments in the study protocol, data
collection forms, informed consent forms, budget expenses, salaries, other trial documents, etc.
as and when they occur. No major changes in the treatment arms or the study protocol or
randomization technique will be carried out without prior permission of theIRB.
21. The investigators realize that the IRB is particular that all aspects of the study are in accordance
with the ICH-GCP and ICMR ethical guidelines, 2006. The investigators will comply with all
policies and guidelines of the MCC and affiliating/collaborating institutions where this study will be
conducted, as well as with all applicable laws regarding theresearch.

We the investigators of the proposed trial have read all the statements listed above and
agree to observe / undertake these IRB requirements while conducting our proposed
project/trial

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We understand that serious protocol violations and/or non-compliance during the trial by
the investigators may result in withdrawal of project approval byIRB

Study team undertaking with duties & delegation*:

Investigator Name Status (PI/Co- Role & Conflict of Signature with date
PI,CI etc.) Responsibility Interest
** (Yes/No)
If yes, please
specify as an
attachment
1

10

Please provide details (an one page CV) of Co-PIs , CIs, Clinical Research Coordinator, Research Nurse,
Phlebotomist, other stuffs related to the study. Use separate sheets for each individual.

** Choose from the following list:

A. Concept J. Examination of patients onfollow-up
B. Design K. Data collection and monitoring ofdata
C. Screening of patients L. Interpretation ofdata
D. Selection & Recruitment and consenting ofpatients M. Statistical analysis &Interpretation
E. Laboratoryinvestigations N. Maintaining patients file and master file of
F. Laboratory reportinterpretation project
G. Treatmentdecision O. Drafting finalreport
H. Patientevaluation P. Publication
I. AE and SAE management, evaluation andreporting Z. Any other, please specify

Note: Investigators may clarify any of the points in this undertaking with the IRB office of MCC.

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To
The Member Secretary
Institutional Ethics Committee
Institutional Review Board, Malabar Cancer Centre

Project Title:

Name of PI:
1

Conflict of Interest:
(Please tick in the appropriate box)

I hereby declare that I have no conflict of interest in my project.

I have following conflict ofinterest:

Signature of PI

Date

Consent of Head of the PI’s Department

Date: (dd/mm/yyyy)…………………

IhavereviewedtheaboveprojectsubmittedbyPrincipalInvestigator,
……………………………………………………………………from myDepartment/Institution.

I endorse the project and have ‘no objection’ for submission for consideration by Institutional Review Board.
I concur with the participants / investigators included in the study. Signature & date :
Name:
Department:

OFFICE SEAL

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