-: INDEPENDENT ETHICS COMMITTEE, NAGPUR PROF. DR. A.G. SHEMBEKAR M.D. (Pharmacology) Chairman Ph. (0712)2454687 DR. PWARADKAR MD, Psychiatrist Member Secretary (M) 9373107196 REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTE CIO Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli, Nagpur- 440012, TEL: 0712-6632200, 6632240 FAX: 0712-2441046,2461249 email: [email protected]MEMBERS' Date: 7Jul 2010 Dr. R. Swarnakar D.N.B. (Pulmonary Medicine) Ph: (0712) 2226219 Dr. Mrs. S. Paranjape MD, Physician (M) 9890445496 Dr. Jayesh Timane MD, Physician (M) 9823584876 Dr. V. Ridhorkar MCh, Urologist (M) 9373101536 Mrs. Liza Firdosi B.Pharm, MBA, Pharmacist, (M)9822941812 Adv. S.W. Maruskar LLB, Lawyer (M) 9370999234 Ms. Shilpa Agrawal MSc, Counselor (M) 9890627404 Mr. Rajendra Jain Community Rep. (M) 9823176485 Ref No: IEC/10/0619-1 To, Dr.Rajesh Swarnakar Getwell Hospital, 20/1, Khare Marg, Dhantoli, Nagpur- 440015 Subject: Ethics Committee approval for the conduct of the referenced study. Reference: Study Code: 205.452 Study Title: "A randomised, active controlled, double blind, double dummy, parallel group, design,multi-centre, trial to compare, the efficacy and safety of 2.5 IJg and 5 IJg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 IJg delivered by the HandiHaler®". Dear Dr. Swarnakar, We have received from you the following documents: Your letter dated 12 May 2010, with regards to the proposal of carrying out the referenced study at Getwell Hospital and Research Institute, Nagpur. Sr. Documents Version Number and Version Date No. 1. Study protocol Final Protocol dated 17th Feb 2010 044 - 053 Investigator's Brochure or 2. package insert or safety data \Lersion 17 and 05 Feb 2010 044 - 053
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INDEPENDENT ETHICS COMMITTEE,NAGPUR
PROF. DR. A.G. SHEMBEKARM.D. (Pharmacology)ChairmanPh. (0712)2454687
DR. PWARADKARMD, PsychiatristMember Secretary(M) 9373107196
Subject: Ethics Committee approval for the conduct of the referenced study.
Reference: Study Code: 205.452
Study Title: "A randomised, active controlled, double blind, double dummy,parallel group, design,multi-centre, trial to compare, the efficacy and safety of 2.5IJg and 5 IJg Tiotropium Inhalation Solution delivered by the Respimat® Inhalerwith Tiotropium inhalation capsules 18 IJgdelivered by the HandiHaler®".
Dear Dr. Swarnakar,
We have received from you the following documents:
Your letter dated 12 May 2010, with regards to the proposal of carrying out the
referenced study at Getwell Hospital and Research Institute, Nagpur.
Sr. Documents Version Number and Version DateNo.
1. Study protocol Final Protocol dated 17thFeb 2010044 - 053
Investigator's Brochure or2. package insert or safety data \Lersion 17 and 05 Feb 2010
044 - 053
INDEPENDENT ETl!tCS COMMITTEE,NAGPL"R
PROF. DR. A.G. SHEMBEKARM.D. (Pharmacology)ChairmanPh. (0712)2454687
DR. PWARADKARMD, PsychiatristMemberSecretary(M) 9373107196
MSc, Counselor Back translation of the dated 16th Apr 10(M)9890627404 7. Subject Informed Consent Reference: India- Marathi - Dr. Rajesh
Form Marathi to English (Site Swaranakar - Version 2 dated 16th
Mr. Rajendra Jain Specific) Apr 10
Community Rep. Back translated from Marathi toEnqlish on 22 Apr 10
(M) 9823176485 Version: India- Urdu- Dr. RajeshSwarnakar - Version 2 dated 16th Apr
Translation of the Subject 108. Informed Consent Form in Ref: India-English- Dr. Rajesh
Urdu (Site Specific) Swarnakar - Version 2 dated 16th Apr10Translated from Enqlish to Urdu on 22
INDEPENDENT ETHICS COMMITTEE,NAGPUR
PROF. DR. A.G. SHEMBEKARM.D. (Pharmacology)ChairmanPh. (0712)2454687
DR. P WARADKARMD, PsychiatristMember Secretary(M) 9373107196
REGD. OFFICE: GETWEll HOSPITAL & RESEARCH INSTITUTECIO Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli,Nagpur- 440012, TEL 0712-6632200,6632240FAX: 0712-2441046,2461249 email: [email protected]
MEMBERS:Sr. Documents Version Number and Version Date
Dr. R. Swarnakar No.
D.N.B. (PulmonaryMedicine) Apr 10
Ph: (0712)2226219
Dr. Mrs. S. Paranjape Version: India-English Backtranslation-M0, Physician Dr. Rajesh Swaranakar-Version 2(M) 9890445496 Back translation of the dated 16th Apr 10
9.Subject Informed Consent Ref: India- Urdu - Dr. Rajesh
Dr. Jayesh Timane Form Urdu to English (Site Swaranakar -' Version 2 dated 16th
M0, Physician Specific) Apr10
(M) 9823584876 Back translated from Urdu to Englishon 22 Apr 10
Dr. V. RidhorkarI Patient trial identification card
MCh, Urologist 10. Final Version dated 11thFeb 2010in English
(M) 9373101536
Mrs. Liza Firdosi Patient trial identification card Hindi Translation version is" MarB.Pharm, MBA, 11. in Hindi 2010Pharmacist,(M)9822941812
Adv. S.W. Maruskar 12.Patient trial identification card Back translated from Hindi to Englishin Hindi(Back translation) on is" Mar 2010
LLB, Lawyer(M) 9370999234
Ms. Shilpa Agrawal 13.Patient trial identification card Marathi Translation version is" Marin Marathi 2010
MSc, Counselor(M)9890627404
Mr. Rajendra Jain 14.Patient trial identification card Back translated from Marathi toin Marathi(Back translation) English on is" March 2010
Community Rep.(M)9823176485
15.Patient trial identification card Marathi Translation version is" Marin Urdu 2010
L DEPENDENT ETHICS COMMITTEE,NAGPUR
PROF. DR. A.G. SHEMBEKARM.D. (Pharmacology)ChairmanPh. (0712)2454687
DR. PWARADKARMD, PsychiatristMember Secretary(M) 9373107196