Dr. A.G. Shembekar MD.(Pharmacology) Chairman Ph: (0712)2454687 INDEPENDENT ETHICS COMMITTEE, NAGPUR Dr. Praveer Waradkar MO, Psychiatrist Member Secretary (M) 9373107196 REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTE c/o Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli, Nagpur - 440012, TEL: 0712-6632200, 6632240 FAX.: 0712-2441046, 2461249 email: [email protected]MEMBERS: Date: 24th July 2010 Dr. Rajesh Swarnakar D.N.B. (Pulmonary Medicine) Ph: (0712) 2226219 Dr. Jayesh Timane MO, Physician (M) 9823584876 Dr. Mrs. S. Paranjape MO, Physician (M) 9890445496 Dr. V. Ridhorkar MCh, Urologist (M) 9373101536 Mrs. Liza Firdosy 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/10/0724-1 To Dr. Rajesh Swarnakar, Getwell Hospital and Research Institute, 20/1, Dr. Khare Marg, Dhantoli, Nagpur - 440012. Subject: Ethics Committee Submission for the conduct of the study As Per Protocol CQV A149A2304, titled "A 52-week treatment, multi-center, randomized, double-blind, parallel-group.active controlled study to evaluate the effect ofQVA149 (110/50llg o.d.) vs NVA237 (50llg o.d.) and open-label tiotropium (181lg o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD)" Study code: Protocol No. CQVA149A2304 Dear Dr. Rajesh Swamakar, The Ethics committee meeting was held on date 24th July 2010. Following Members were present during this meeting: 1. Dr. A.G Shembekar M (Chairperson) 2. Dr. Praveer Waradkar M.D Psychiatrist, No (Member M Secretary) 3. Mrs. Liza Firdosy B.Pharm., M.B.A, No (Member) F 4. Dr. Mrs Shilpa M.D Physician ,Yes (Member) F Paranjape 5. Dr. Jayesh Timane M.D Physician ,Yes (Member) M 6. Adv. S.W. Maruskar L.L.B, No ( Lawyer) M 7. Shilpa Agrawal M.Sc, No (Social Worker) F 8. MI'. Rajendra Jain M.Com, No (Lay Person) M
Transcript
Dr. A.G. ShembekarMD. (Pharmacology)ChairmanPh: (0712)2454687
INDEPENDENT ETHICS COMMITTEE,NAGPUR
Dr. Praveer WaradkarMO, PsychiatristMember Secretary(M) 9373107196
REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTEc/o Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli,
Ref No. IEC/10/0724-1ToDr. Rajesh Swarnakar,Getwell Hospital and Research Institute,20/1, Dr. Khare Marg, Dhantoli,Nagpur - 440012.
Subject: Ethics Committee Submission for the conduct of the study As PerProtocol CQV A149A2304, titled "A 52-week treatment, multi-center,randomized, double-blind, parallel-group.active controlled study to evaluatethe effect ofQVA149 (110/50llg o.d.) vs NVA237 (50llg o.d.) and open-labeltiotropium (181lg o.d.) on COPD exacerbations in patients with severe to verysevere chronic obstructive pulmonary disease (COPD)"
Study code: Protocol No. CQVA149A2304
Dear Dr. Rajesh Swamakar,
The Ethics committee meeting was held on date 24th July 2010. Following
Members were present during this meeting:
1. Dr. A.G Shembekar M
(Chairperson)
2. Dr. Praveer Waradkar M.D Psychiatrist, No (Member M
Secretary)
3. Mrs. Liza Firdosy B.Pharm., M.B.A, No (Member) F
4. Dr. Mrs Shilpa M.D Physician ,Yes (Member) F
Paranjape
5. Dr. Jayesh Timane M.D Physician ,Yes (Member) M
6. Adv. S.W. Maruskar L.L.B, No ( Lawyer) M
7. Shilpa Agrawal M.Sc, No (Social Worker) F
8. MI'. Rajendra Jain M.Com, No (Lay Person) M
Dr. A.G. ShembekarMD. (Pharmacology)ChairmanPh: (0712)2454687
INDEPENDENT ETHICS COMMITTEE,NAGPUR
Dr. Praveer WaradkarMO, PsychiatristMember Secretary(M) 9373107196
MD, Physician 5.13 Investigator Notification- Circulatory collapse and Amnesia,(M)9890445496 PHHY2010DEI9288 dated 01 April, 2010
Dr. V. Ridhorkar 5.14 Investigator Notification- Cardiomyopathy, VentricularMCh, Urologist hypokinesia, and Supraventricular tachycardia, PHH020 1OUS04700(M) 9373101536 dated 01 April, 2010
10 St. George's Respiratory Questionnaire:MEMBERS:10.1 English
Dr. Rajesh Swarnakar10.2 HindiD.N.B. (Pulmonary Medicine)
Ph: (0712)2226219 10.3 Urdu
Dr. Jayesh Timane 10.4 Marathi
MO, Physician 11 Paper Patient Diary :(M) 9823584876
11.1 English dated 28-Mar-2007
Dr. Mrs. S. Paranjape 11.2 Hindi dated 28-Mar-2007MO, Physician 11.3 Urdu dated 28-Mar-2007(M) 9890445496
11.4 Marathi dated 28-Mar-2007Dr. V. Ridhorkar Investigator's Undertaking, CV and Medical RegistrationMCh, Urologist 12 Certificate from the Principal Investigator.(M) 9373101536
13Insurance Certificate dated 04 June 2010
Mrs. Liza FirdosyInvestigators and the members of the study teamB.Pharm, MBA, did not participate m
Pharmacist, deliberations and voting of the said study during the meetings.(M) 9822941812
The Ethics committee functions as per the requirements of the ICH-GCP andAdv. S.W. Maruskar their SOP's.LLB, Lawyer
Please keep the Ethics Committee informed about any deviation / changes(M) 9370999234
Ms. Shilpa Agrawalmade to the protocol and all Adverse Events that are both serious and
MSc, Counselor unexpected or any new information that may affect adversely the safety of the
(M) 9890627404 subjects participating in trial. You are also obliged to inform the progress of the
Mr. Rajendra Jain study annually to the Ethics committee.Community Rep.(M) 9823176485
