GroupforResearchAdvancement inClinicalEthicsDr. Animesh Arya Centre for Chest Diseases, Allergy...
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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
Transcript of GroupforResearchAdvancement inClinicalEthicsDr. Animesh Arya Centre for Chest Diseases, Allergy...
Secretary General:Dr. S.K. DasManobal KlinikA·2, Rajouri GardenNew Delhi·l1 0027Tel; 09810537325E·mllii:[email protected] Dear Dr. Arya ,
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
Telefax: (011) 25172059 / 25934802 Email: [email protected]
05/07/2012
ToDr. Animesh AryaCentre 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 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]
Treasurer:Dr. R.K. Bhatia0·11/31, Janak Puri,New Delhi - 110058:rei: 28520968Ernail: [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
'. President:Dr. K. Satyanarayana
. Chief, Division of Publication &
InformationAnd Intellectual Property & RightsIndian Council of Medical ResearchV. Ramalingaswami Bhawan,Ansari Nagar, New·Delhi·ll 0029(INDIA)
SecretBry GenerBtDr. S.K. OasManoba! KlinikA·2, Rajouri GardenNew Delhi·l1 0027Tel: 09810537325E·mail:[email protected]
Vice - President:Or. Smita ~J.OeshpandeHead, Dept 0.1 Psychiatry,Dr. Ram Manohar lohia Hospital,Park Street, New Delhi - 110001Tel: 23404269, 23442122E:mail: [email protected] .
Treasurer.Dr. R.K. Bhatia'0·11131, Janak Puri,
New Delhi - 110058Tel: 28520968E·mail: [email protected]
Group for Research Advancement in Clinical EthicsRegd. Office Ii: Secretariat: Manobal Klinik, A-2., Rajouri Garden, New Delhi 11002.7
Telefax: (011) 251n059 / 25934802 Email: [email protected]
The Ethics Committee has reviewed and approved the following documents
received from you via your letter 6"' March 2012.
Sr. No ntle
L Amended Protocol (Version l;Dated: 05-Jan-12).
2. Investigator's Brochure (Edition 5; Dated:24-Jan-12)
3. ECRF Layout (Amendment 1; Dated: 04-Nov-ll)
4. SGRQQuestionnaires in:
· English & Hindi
5. BDI Questionnaires in:
· English & Hindi
6. TOI Questionnaires in:
· English & Hindi
7. Patient Cards AM3 in:
.' English & Hindi
8. Paper Diary in :
· English & Hindi
9. Vacation cards in:
· English & Hindi
10. Patient cards in:
· English & Hindi (Translated to Hindi on 03-Nov-20ll)11. eDiary Layout In:
· English & Hindi
12. DCGISubmission Letter dated 07-Dee-20ll
13. Insurance Certificate
14. Investigator's Undertaking
15. CV & MRC of Principal Investigator
16. Patient Information Sheet + Informed Consent Form in English CoreStudy (Version 1.1, dated 19-Jun-2012)
17. Patient Information Sheet + Informed Consent Form in Hindi Core Study
(Version 1.1, dated 19·Jun·2012; translated to Hindi on 26-Jun-2012)
Informed Consent Form Version 1 (English and Hindi) should not be used. Also, as
per the letter dated 12-Jun-2012, site is not participating in Pharmacogenetic
study; hence Pharmacogenetic ICFis not approved by the Ethics Committee. We
have also received the ICFversion 1.1 in English and Hindi on 5-Jul-2012. As therequired changes have been incorporated in the ICF& the same has been
approved by Ethics Committee.
Group for Research Advancement in Clinical EthicsRegd. Office ft Secretariat: Manobal Klinik, A-2, Rajouri Garden, New Delhi 110027
Telefax: (011) 25172059 /25934802 Email: [email protected]
President:Dr. K. Satyanarayana
, Chief, Division of Publication &InformationAnd-Intellectual Property & RightsIndian Council of Medical ResearchV, Hamabnqaswemi Bhawan,Ansari Nagar, New-Delhi-ll 0029(INDIA) I ,
Secretary General:Dr. S.K. DasManobal KlinikA·2, Rajouri GardenNew Delhi-l1 0027Tel: 09810537325E-mail:[email protected]
Vice - President:Dr. Smita N. DeshpandeHead, Dept. of Psychiatry,Dr. flam ~anohar Lohia Hospital.Park Str-eet. New Delhi - 110001Tel: 23404269, 23442122Ernail; [email protected]
Treasurer:Or. R.K. Bhatia0·11131,Janak Puri,New Delhi - 110058Tel: 28520968E-mail: [email protected]
Investigators and the members of the study team did not participate In
deliberations and voting of the said study riming the meetings.
The Ethics committee functions as per the requirements of the ICH-GCP and
their SOP's.
Please keep the Ethics Committee informed about any deviation / changes made
to the protocol and all Adverse Events that are both serious and unexpected or
any new information that may affect adversely the safety of the subjects
participating in trial. You are also obliged to 'inform the progress of the study
annually to the Ethics committee.
Name: --------------~-------Sign with Date:
Chairman, Ethics committee / Authorized Signatory, Ethics committee
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