RTIICS ETHICS COMMITTEE 124, Muiilndapur, KOLKATA-99

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RTIICS ETHICS COMMITTEE 124, Muiilndapur, KOLKATA-99

RTIICS ETHICS COMMITTEE RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES 124, MUIilNDAPUR, KOLKATA-99. CHAIRPERSON MEMBERS: Dr. E.Rupert Mrs. S.Y.Dastur Dr. S.K.Tripathi Dr. Joydip Mukhopadhyay Dr.(Col)Tapas Ray Dr. Debika Chatterjee Dr. RS.Joshi SECRETARY Mrs. A. Johri Mr. Binod Khaitan Mr.S.B.Chakraborty Mr.IC Chandramohan Ref: RTIICS-EC-A/007f201 I Date :l2thAug2011. To, Dr. Debdatta Bhattacharya, Consultant Interuentional Caidiologist, Rabindranath Tagore International Institute of Cardiac Sciences, l2d Mukundapur, E.M Bypass Kolkata 700 (D9. $ub: IEC Decision on Review of the documents submitted. Title- a "A Prospedive, Single Blinded, Multi-centreo Randomized Trial to Comnare the fAXUS Element Coronary Stent System against the IIENCE Prime Coronaly Stent System in the treatment of Diabetic Patient PopulatiOn irn India. (TU)(EDO)." Study Site : Rabindranath Tagore lntemational tnstitute of Sciences, 124, Mukundaput E.M Bypass Kolkata 700 099 i Page I of2 Dear Dr. D.Bhattacharya . (DthAug20l1., In its meeting held on the members of IEC had reviewed and discussed the documents submitted for approval for the clinical study entitled : lf Prospective, Single Blinded, Multi-oentre, Randomized Trial to Compare the IAXUS Element Coronary Stent System against the XIENCI Prime Coronary Stent Systern in the treatment of Diabetic Patient PopulatiOn in India. (TUXEDO).' l) The following documents were reviewed : l. Protocol Version 02 Date l6Dec20l0. 2. Direction for use for Taxus Element Coronarv Stent Svstem 3. Diroction for use for XIENCE prime Coronary Stent dystem 4. India Site Specific lCF, English-version 2.0Date23May2}lt. 5. Draft Final CTA 6. CRF-version 01 datetSMay2}ll. 7. Revised Final Insurance Certificate & List of Sitei insured. 8. Principal Investigator CV&MRC. 9. Investigator Undertaking. l0- DCGI Submissioh letter. I l. DCGI Approval Letter. l2.EC Query Response Letter by Sponsor. 13. Protocol Clarification Form -version L0 Date 25Julv20l l. iD The Committee should be informed: a. about the progress of the study every six months b' any Serious Adverse Events occurring in the course of the study within l4 calendar days oftheir occturence c. any changes in the protocol and patient information/i4formed consent documents, prior to their implementation. liiil Approval is granted to the above mentioned documents, to be conducted in the present forin and the investigator is requested to periodically update and inform the Ethics Committee about the compliance of ethical issues. (iv) Final report of the study sball have to be submitted to the IEC in all cases. even when the study is abandoned for any neason. (v) The following members of the Committee were present: l. Mr.S.B.Chakraborty Member Secretary 2. Dr. S.K.Tripathi Medical Scientist (Pharmacologist) 3. Dr. E.Rupert Member - Clinician 4. Dr.(Col) Tapas Ray Member - Clinician 5. Dr. Debika Member- Clinician Member-Social Assistance Provider Chairperson IEC Page2 ofZ.

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