GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC) Dr. Rajesh Swarnakar D.N.B. (Pulmonary Medicine) DTCD, FCCP (USA) Member Secretary Ph: (0712) 6632203 Prof. Dr.A.G.Shembekar M.D. (Pharmacology) Chairman (M) 9822578307 REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg, Dhantoli, Nagpur-440012(lndia) TEL: 0712-6632200, 6632240 FAX: 0712-2441046, 2461249 email: [email protected]MEMBERS: Dr. Jitendra Hazare MS,MCH (Paed Surgeon) (M)9822203622 Dr. Jayesh Timane MD, Physician (M) 9823584876 Dr. Vikrant Saoji MD (Dermatology) (M) 9822697892 - Mr.Hitesh Matte D.Pharm Pharmacist, (M) 9822561109 Adv. S.W. Maruskar LLS, Lawyer (M) 9370999234 Ms. Shilpa Agrawal MSc,Social Counselor (M)9890627404 Mr.Agnelo Pinto SA, Lay Person (M) 9373284869 Ref.No. GIEC/12/1222-01 Date: 01/Jan/2013 To, Dr. Jayashri Shembalkar . 20/1,Getwell Hospital and Research Institute Dr.Khare Marg, Dhantoli, Nagpur-440012 Ref Study No: GPL/CT/2012/00S/1I1 Study Title: "A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy,Safety and Tolerability of Fixed Dose Combination of Repaglinide / Metformin IR Tablet Compared with Metforrnin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone." Subject: Ethics Committee approval of study related documents for the referenced study. • Dear Dr.Shembalkar With ref. to your letter to us dated: 19/Nov/2012.The Getwell Institutional Ethics Committee reviewed the study documents for the clinical trial entitled "A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy,Safety and Tolerability of Fixed Dose . Combination of Repaglinide / Metformin IR Tablet Compared with Metformin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Page 1 of 4
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GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)
Dr. Rajesh SwarnakarD.N.B. (Pulmonary Medicine)DTCD, FCCP (USA)Member SecretaryPh: (0712) 6632203
Prof. Dr.A.G.ShembekarM.D. (Pharmacology)
Chairman(M) 9822578307
REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,
Study Title: "A Randomized, Double Blind, Comparative,Prospective, Multicentre, Parallel Study to assessEfficacy,Safety and Tolerability of Fixed Dose Combinationof Repaglinide / Metformin IR Tablet Compared withMetforrnin IR Tablet Monotherapy or Repaglinide TabletMonotherapy in Adult Patients with Type 2 DiabetesMellitus Inadequately Controlled on Metformin Alone."
Subject: Ethics Committee approval of study related
documents for the referenced study.
• Dear Dr.Shembalkar
With ref. to your letter to us dated: 19/Nov/2012.The GetwellInstitutional Ethics Committee reviewed the study documents
for the clinical trial entitled "A Randomized, Double Blind,Comparative, Prospective, Multicentre, Parallel Study toassess Efficacy,Safety and Tolerability of Fixed Dose
. Combination of Repaglinide / Metformin IR TabletCompared with Metformin IR Tablet Monotherapy orRepaglinide Tablet Monotherapy in Adult Patients with
Page 1 of 4
--GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)
Dr. Rajesh'SwarnakarO.N.B. (Pulmonary Medicine)OTCO, FCCP (USA)Member SecretaryPh: (0712)6632203
Prof. Dr.A.G.ShembekarM.D. (Pharmacology)
Chairman(M) 9822578307
REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,
Type 2 Diabetes Mellitus Inadequately Controlled onMetformin Alone."On 22/Dec/2012 at 5.00 pm.
The following documents were reviewed:
•
I. Protocol Version 2.0 dated 12/0ct/20l2.2. Patient Information Sheet and Informed Consent Formin English, Version 3.0 dated 17/0ct/2012, Customized forDr. Jayashri Shembalkar on 05/Nov/2012.3. Patient Information Sheet and Informed Consent Formin Hindi, Version 2.0 dated 29/0ct/20l2, Customized forDr. Jayashri Shembalkar on 05/Nov/2012.4: Patient Information Sheet and Informed Consent Formin Marathi, Version 2.0 dated 23/0ct/2012, Customizedfor Dr. Jayashri Shembalkar on 05/Nov/20l2.5. Patient Diary in English, Version 2.0 dated 12/octI2012.6. Patient Diary in Hindi, Version 2.0 dated l2/oct/20l2,Translated from English to Hindi on 30/oct/2012.7. Patient Diary in Marathi, Version 2.0 dated 12/0ct/2012,Translated from English to Marathi on 02/NovI2012.8. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, in English.9. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, Translated from English toHindi on 02/Nov/20l210. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, Translated from English toMarathi on 05/Nov/20l21]. Case Report Form Version 3.0 dated 05/Nov/2012with updated pages 7, 8, 9, 11, 15, 19 & 23.
12. Investigator's undertaking dated 01lOct/20l2.
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--GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)
Dr. Rajesh SwarnakarD.N.B. (Pulmonary Medicine)DTCD, FCCP (USA)Member SecretaryPh: (0712) 6632203
Prof. Dr.A.G.ShembekarM.D. (Pharmacology)
Chairman(M) 9822578307
REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,