~ ~ Narayana Hrudayalaya Medical Ethics Committee Narayana Hrudayalaya Hospitals Caring with Compassion CHAIRMAN & LEGAL EXPERT Dr. S.Y. Joga Rao To, Dr Sanjay Mehrotra, Sr.Consultant cardiologist, Narayana Hrudayalaya Hospitals, No. 258/ A, Bommasandra Industrial Area, Anekal Taluk, Bangalore-560 099, India Dr. Lloyd Vincent (Academician) Ref: "UMPIRE - Use of a Multidrug fill !n Reducing card i ovascu lar~ vents". Protocol Number: 241849. EudraCT Number: 2009-016278-34. Product: Red Heart Pill. Sponsor: Imperial College London. Dr. George Cherian (Academician) Dr. P.S. Jairaj (Academician) Dr. Ashley D'cruz (Pediatric Surgeon) Dr. K.V. Nataraj (Basic Medical Scientist Pharmacologist) Sub: Ethics Committee approval for the conduct toclinical trial "UMPIRE -1!se of a Multidrug fill !n Reducing cardiovascular ~vents". Protocol Number: 241849. Rev. K. Vasudevan (Theologian) Dr. Muralidhar K. (Academician) With reference to your submission letter dated "4 oct 2010 "we wish to inform youthat the "Narayana Hrudayalaya Medical Ethics committee" reviewed and discussed your application to conduct theclinical trial entitled "UMPIRE - 1!se of a Multidrug fill!n Reducing cardiovascular ~vents" on "3 Nov 2010" Dr. Srikrishna (Academician) Dr. Murali Mohan (Academician) Dr. Anuradha B.S. (Women & Child care) Mr. Anil Shankar (General Public) Mrs. Geeta MK (Medical Social Worker) l.UMPIRE Study Protocol Version 2, dated 21 April 2010 2.Summary of changes to UMPIRE study protocol Version 1.1 dated 28 Jan 2010 to Version 2 dated 21 April 2010 3.Participant information sheet with informed consent Form: Version 2, dated 11 May 2010 (English, Hindi and Kannada) 4.Summary of changes to participant information sheet with informed consent form version 1 dated 10 Dee 2009 to Version 2 dated 11 May 2010 S.Translation certificate Dated 20 May 2010 6.DCGI approval for the conduct of UMPIRE study Dated 03 May 2010 7.Product liability Insurance # 258/A, Bommasandra Industrial Area, Anekal (Taluk), Bangalore - 560 099. Tel.: 080-27835000 to 18 (Extn.: 2124) Fax: 080-27832648 Mob: +91-95350 12356
3
Embed
Narayana Hrudayalaya Narayana Hrudayalaya …...Narayana Hrudayalaya Medical Ethics Committee Narayana Hrudayalaya Hospitals Caring withCompassion CHAIRMAN & LEGAL EXPERT Dr. S.Y.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
~
~
Narayana HrudayalayaMedical Ethics Committee
NarayanaHrudayalayaHospitals
Caring with Compassion
CHAIRMAN &LEGAL EXPERT
Dr. S.Y. Joga Rao
To,Dr Sanjay Mehrotra,Sr.Consultant cardiologist,Narayana Hrudayalaya Hospitals,No. 258/ A, Bommasandra Industrial Area, Anekal Taluk,Bangalore-560 099, India
Dr. Lloyd Vincent(Academician)
Ref: "UMPIRE - Use of a Multidrug fill !n Reducingcard iovascu lar~ vents".Protocol Number: 241849. EudraCT Number: 2009-016278-34.Product: Red Heart Pill. Sponsor: Imperial College London.
Dr. George Cherian(Academician)
Dr. P.S. Jairaj(Academician)
Dr. Ashley D'cruz(Pediatric Surgeon)
Dr. K.V. Nataraj(Basic Medical Scientist
Pharmacologist)
Sub: Ethics Committee approval for the conduct to clinical trial"UMPIRE - 1!se of a Multidrug fill !n Reducing cardiovascular~vents". Protocol Number: 241849.
Rev. K. Vasudevan(Theologian)
Dr. Muralidhar K.(Academician)
With reference to your submission letter dated "4 oct 2010 "wewish to inform you that the "Narayana Hrudayalaya MedicalEthics committee" reviewed and discussed your application toconduct the clinical trial entitled "UMPIRE - 1!se of a Multidrugfill!n Reducing cardiovascular ~vents" on "3 Nov 2010"
Dr. Srikrishna(Academician)
Dr. Murali Mohan(Academician)
Dr. Anuradha B.S.(Women & Child care)
Mr. Anil Shankar(General Public)
Mrs. Geeta MK(Medical Social Worker)
l.UMPIRE Study ProtocolVersion 2, dated 21 April 20102.Summary of changes to UMPIRE study protocolVersion 1.1 dated 28 Jan 2010 to Version 2 dated 21 April20103.Participant information sheet with informed consentForm: Version 2, dated 11 May 2010 (English, Hindi and
Kannada)4.Summary of changes to participant information sheetwith informed consent form version 1 dated 10 Dee 2009to Version 2 dated 11 May 2010S.Translation certificateDated 20 May 20106.DCGI approval for the conduct of UMPIRE studyDated 03 May 20107.Product liability Insurance
III Narayana=¥= HrudayalayaIII HospitalsCaring with Compassion
CHAIRMAN &LEGAL EXPERT
Dr. S.v. Joga Rao
We approve the trial to be conducted"Narayana Hrudayalaya Hospital"
The Institutional Reveiw Board / Independent Ethics Committeeexpects to be informed about the progress of the study, any SAEoccurring in the course of the study, any changes in the protocol andpatient information / informed consent and asks to be provided a copyof the final report.
Dr. Lloyd Vincent(Academician)
The EC is organized & operates according to the requirements of ICH-GCr, Indian Council of Medical Research guidelines & Schedule Y.