Secretary General: Dr. S.K. Das Manobal Klinik A·2, Rajouri Garden New Delhi·l1 0027 Tel; 09810537325 E·mllii:[email protected]Dear Dr. Arya , President: Dr. K. Satyanarayana Chief, Division of 'Publication & Information And Intellectual Property & Rights lndian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, New·Delhi·l10029 (INDIA) Group for Research Advancement in Clinical Ethics Regd, Office ft Secretariat: Manobal Klinik, A-2, Rajouri Garden, New Delhi 110027 Telefax: (011) 25172059 / 25934802 Email: [email protected]05/07/2012 To Dr. Animesh Arya Centre for Chest Diseases, Allergy & sleep Disorder, 8-3/17 Paschim Vihar , Near Jwala Heri Market, New Delhi-110063, . India Subject: Ethics Committee Approval for the conduct of the study As Per Protocol CNV A237 A2309, titled "A 26-week treatment multi-center, randomized, doubleblind, parallel-group, placebo and active controlled (open label) study to assess the efficacy, safety and tolerability ofNV A237(50 p.g o.d.) in patients with chronic obstructive pulmonary disease (COPD)" Study code: Protocol No. CNV A237 A2309 Vice - President: The Ethics committee meeting was held on is" May 2012. Following Members Dr. Smita N. Deshpande were present during this meeting: Head, Dept. of Psychiatry, '. Dr. Ram Manohar lohia Hospital, Park Street, New Delhi -110001 Tel: 23404269, 23442122 Ernail; [email protected]Treasurer: Dr. R.K. Bhatia 0·11/31, Janak Puri, New Delhi - 110058 :rei: 28520968 Ernail: [email protected]Sr. , <Name Qualifications & Affiliation Gender No· . (Professnn, Doctor,La)¥Y<¢,:r., .(Male( --, Social Worker, etc. ..) Female) " - 1. Dr. K. Satyanarayan (Chairman) PHD (Administrative & Male either issues) 2. Dr. Smita N. Deshpande(Vice President) MD (Clinical & Research) Female 3. Dr. S.K. Das (Secretary General) PHD (Clinical & Research) Male 4. Mr. R.K. Bhatia (Treasurer) M.Sc (Vital Statistics) Male 5. Dr. Rajesh Nagpal (Member) MD (Clinical & Research) Male 6. Dr. V. Sreenivas (Member) PHD (Biostatistics) Male 7. Mr. Ezekiel Issac Malekar (Member) LLB (Law & human rights) Male 8. Dr. I.M. Khungar (Member) MD (Hematology) Male 9. Dr. N.N. Mishra (Member) PHD (Genetic Psychiatry) Male 10. Dr. Triptish Bhatia (Member) PHD Female 11. Mr. Sumit ·Phatela (Member) LLB (Legal Opinion) Male After satisfactory explanation made by Principal Investigator before all members present in EC Meeting and due submission of required papers and also after further discussion with Chairman with regard to shifting of Biological Material which they are not using as committed, We are pleased to give approval of the study. Page 1 of3
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GroupforResearchAdvancement inClinicalEthicsDr. Animesh Arya Centre for Chest Diseases, Allergy &sleep Disorder, 8-3/17 Paschim Vihar , Near Jwala Heri Market, New Delhi-110063,. India
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President:Dr. K. SatyanarayanaChief, Division of 'Publication &InformationAnd Intellectual Property & Rightslndian Council of Medical ResearchV. Ramalingaswami Bhawan,Ansari Nagar, New·Delhi·l10029(INDIA)
Group for Research Advancement in Clinical EthicsRegd, Office ft Secretariat: Manobal Klinik, A-2, Rajouri Garden, New Delhi 110027
Subject: Ethics Committee Approval for the conduct of the study As PerProtocol CNV A237 A2309, titled "A 26-week treatment multi-center,randomized, doubleblind, parallel-group, placebo and active controlled (openlabel) study to assess the efficacy, safety and tolerability ofNV A237(50 p.go.d.) in patients with chronic obstructive pulmonary disease (COPD)"
Study code: Protocol No. CNV A237 A2309
Vice - President: The Ethics committee meeting was held on is" May 2012. Following Members
Dr. Smita N. Deshpande were present during this meeting:Head, Dept. of Psychiatry,
'. Dr. Ram Manohar lohia Hospital,Park Street, New Delhi -110001Tel: 23404269, 23442122Ernail; [email protected]
, Chief, Division of Publication &InformationAnd-Intellectual Property & RightsIndian Council of Medical ResearchV, Hamabnqaswemi Bhawan,Ansari Nagar, New-Delhi-ll 0029(INDIA) I ,