meenakshi mission hospital and research centre

MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE (Run by S.R. TRUST) Lake Area, Melur Road, Madurai - 625 107, Tamilnadu, India ETHICAL REVIEW BOARD Phone : (91 -452) 2588741 (10 lines) 4263000 (6 Lines) Fax : (91 -452) 2586353 E-mail : mmhrc@sancharnetin
Web : http://www.meenakshimission.org Date: 27-Aug-2011
To
Dr. Kirushna Kumar
Meenakshi Mission Hospital and Research Centre
Lake Area, Melur Road, Madurai
Tamil Nadu - 625107
Ref: Pr otocol NamelNo. : CANTARISK study (DIREG_C04823).
I
Study Title: A prospective, non interventional, cohort survey on VTE risk in patients receiving new
chemotherapy for cancer.
Sub: EC Approval for Study Documents
Dear Dr. Kirushna Kumar,
With reference to the above subject we write to inform you that the Ethical Review Board, in its meeting
started at 15.00 hrs and ended at 17.00 hrs on 25-Aug-2011, held at Meenakshi Mission Hospital & Research
Centre, Madurai, reviewed the documents mentioned in your submission letter dated 25-Jul-2011.
t.
Sr.Nb
Documents
1.
2.
Protocol
Case Report Form
Local Master Informed Consent
Form-English
Local Master Informed Consent
Form-Tamil
Local Master Informed Consent
Form-Back Translation Tamil to
English
Draft Clinical Trail Agreement
3.
4.
5.
6.
Version/Date
Protocol Version 5.0 dated: 12-April-2011
Final Version dated 02-March-2011
Version 1.1 dated - 07 -June- 2011
Version 1.1 dated - 07-June-2011 Translated to Hindi
dated 30-June-2011
Back Translated from Tamil to English dated 30-June­
2011
NA
The Ethical Review Board, Meenakshi Mission Hospital and Research centre, Madurai has conducted an
ethical review of the documents for the above referenced clinical study. The IEC reviewed the following
documents & grants its approval.
The following members attended the IEC meeting for the review of this clinical trial:
S No
1
2
Name of the member Role in the EC
Qualification
Dr. A.Velmurugan
Chairperson
Ph.D.{ N), M.Sc., (N)
Dr. V.N.Rajasekaran
Members
Ph.D.{ Hookwork/
Secretary,
Nutrition), M.D., DTM
Basic Medical
& H.
Scientist!
Affiliation [Designation/Title,
Name and Address (City, State)
of Affiliated Institute]
Professor in Nursing (Not
affiliated with MMHRC)
Medical Director, MMHRC,
Madurai, Tamil Nadu
MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE (Run by S.A. TRUST) Lake Area, Melur Road, Madurai - 625 107, Tamilnadu, India ETHICAL REVIEW BOARD Phone : (91 -452) 2588741 (10 Lines) 4263000 (6 Lines) Fax : (91-452) 2586353 E-mail : mmhrc@sancharneU n
Web : http ://www.meenakshimission.org Clinician
I
3
Dr. T.R.Murali,
Clinician
M.S., M.Ch., (Uro)
4
Dr. O.L.Sadasivam,
Clinician
M.S., (Surgery)
5
Dr. Bhuvaneswari
Clinician
M.D., D.G.O. (OaG)
6
Dr. K.Padmini
\
Basic Medical
M. D., (Microbiology)
Scientist
Social Worker M.A., M.Phil., M.B.A.,
/ Philosopher M.Sc., (Psy)
7 t
Ms. N.Chitra
8
Mr. P.T.Sundar
Lay person
9
Dr. N.Kirshnamurthy
Legal
MS., M.Ch., (Uro)
expertiClinici
M.B.A., B.G.L.
an
M.A.
Senior Consultant Urologist,
MMHRC, Madurai, Tamil Nadu
Consultant Surgeon, MMHRC,
Madurai, Tamil Nadu
Consultant Gynecologist,
MMHRC, Madurai Tamil Nadu
Microbiologist, MMHRC,
Madurai, Tamil Nadu
Counselor, MMHRC, Madurai,
Tamil Nadu
Executive Secretary to
Chairman, MMHRC, Madurai,
Tamil Nadu
Acedamic Director MMHRC,
Madurai, Tamil Nadu
We confirm that neither you nor your study team members participated in the deliberations of the Ethics
Committee a did not vote on the proposal for this study.
~,
Promplly report to the IEC:
• Any changes to or deviations to the protocol approved by the IEC that you may implement to eliminate
hazards to the trial subjects
• All serious adverse events
• New information that may affect adversely the safety of the subjects or the conduct of the trial
Please submit to the IEC the status report of the study after every 12 months interval.
The IEC is organized a operates according to the requirements of ICH-GCP a Indian Council of Medical
Research a Schedule Y.
Cordially yours,
Member secretary: _ _
- -,~
~,........,,~----
Date:
THE SECRETARY ETi-f; .#AL REV:EW BOARD Mea 1ai<shi Mission Hosplta' • Resea r _h Centra Lake Area, Melur
Road, MADURAI -625107, 2.- 7 -
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