-: INDEPENDENT ETHICS COMMITTEE, NAGPUR€¦ · Pharmacist, (M)9822941812 Adv. S.W. Maruskar LLB, Lawyer (M) 9370999234 Ms. Shilpa Agrawal MSc, Counselor (M) 9890627404 Mr. Rajendra

-:

INDEPENDENT ETHICS COMMITTEE,NAGPUR

PROF. DR. A.G. SHEMBEKARM.D. (Pharmacology)ChairmanPh. (0712)2454687

DR. PWARADKARMD, 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' Date: 7Jul 2010

Dr. R. SwarnakarD.N.B. (PulmonaryMedicine)Ph: (0712) 2226219

Dr. Mrs. S. ParanjapeMD, Physician(M) 9890445496

Dr. Jayesh TimaneMD, Physician(M) 9823584876

Dr. V. RidhorkarMCh, Urologist(M) 9373101536

Mrs. Liza FirdosiB.Pharm, MBA,Pharmacist,(M)9822941812

Adv. S.W. MaruskarLLB, Lawyer(M) 9370999234

Ms. Shilpa AgrawalMSc, Counselor(M) 9890627404

Mr. Rajendra JainCommunity 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 2.5IJg 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


DR. PWARADKARMD, PsychiatristMemberSecretary(M) 9373107196

REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTECIO Navjeevan Nursing Home, 2011,Dr. Khare Marg, Dhantoli,Nagpur- 440012, TEL: 0712-6632200,6632240FAX: 0712-2441046,2461249 emait [email protected]

MEMBER~'Sr. Documents Version Number and Version Date

Dr. R. Swarnakar No.

D.N.B. (PulmonaryMedicine) Version: India-English - Dr. RajeshPh: (0712) 2226219 3. Subject Informed Consent Swarnakar-Version 2 dated is" Apr 10

Form in English(site specific) Ref: India- English- Version 2 dated

Dr. Mrs. S. Paranjape os" Apr 10

MD, Physician Version: India- Hindi- Dr. Rajesh

(M) 9890445496 Swarnakar - Version 2 dated 16th Apr10Translation of the Subject Ref: India-English- Dr. Rajesh

Dr. Jayesh Timane 4. Informed Consent Form inHindi (Site Specific) Swarnakar - Version 2 dated 16th Apr

MD, Physician 10(M) 9823584876 Translated from English to Hindi on 22

Apr 10

Dr. V. RidhorkarI Back translation of the

Version: India-English Backtranslation-

MCh, UrologistDr.Rajesh Swaranakar-Version 2dated 16th Apr 10

(M) 93731015365. Subject Informed Consent Ref: India- Hindi - Dr.Rajesh

Form Hindi to English (Site Swaranakar - Version 2 dated 16thMrs. Liza Firdosi Specific) Apr 10

B.Pharm, MBA, Back translated from Hindi to English

Pharmacist, on 22 Apr 10Version: India- Marathi - Dr. Rajesh

(M)9822941812 Swarnakar - Version 2 dated 16th AprTranslation of the Subject 10 Reference: India-English- Dr.

Adv. S.W. Maruskar 6. Informed Consent Form in Rajesh Swarnakar - Version 2 datedLLB, Lawyer Marathi (Site Specific) 16th Apr 10

(M) 9370999234 Translated from English to Marathi on22 Apr 10

Ms. Shilpa AgrawalVersion: India-English Backtranslation-Dr. Rajesh Swaranakar-Version 2

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


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


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



REGD. OFFICE: GElWELL 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


D.N.B. (PulmonaryMedicine)

16. Patient trial identification card Back translated from Urdu to EnglishPh: (0712)2226219in Urdu(Back translation) on is" March 2010

Dr. Mrs. S. ParanjapeMD, Physician

Patient Reminder Card in(M) 9890445496 17. English Final Version dated 10 Feb 2010

Dr. Jayesh TimaneMD, Physician

Patient Reminder Card in Translated from English to Hindi on 01(M) 9823584876 18. Hindi March 2010

Dr. V. RidhorkarMCh, Urologist

Patient Reminder Card in Back translated from Hindi to English(M) 9373101536 19. Hindi (Back translation) on 01 March 2010

Mrs. Liza FirdosiB.Pharm, MBA,

Patient Reminder Card in Translated from English to Marathi onPharmacist, 20. Marathi 26 Feb 2010(M) 9822941812

Adv. S.W. MaruskarPatient Reminder Card in Back translated from Marathi to

LLB, Lawyer 21. Marathi(Back translation) English on 01 March 2010(M) 9370999234

Ms. Shilpa Agrawal Patient Reminder Card in Translated from English to Urdu onMSc, Counselor 22. Urdu re" March 2010(M)9890627404

Mr. Rajendra Jain Patient Reminder Card in Translated from Urdu to English onCommunity Rep. 23.

Urdu ( Back translation) is" March 20-1-0(M) 9823176485

24. Reminder card Instructions in Final Version dated 10 Feb 2010English

INDEPENDENT ETHICS COlYfMITTEE,NAGPUR

PROF. DR. A.G. SHEMBEKARM.D (Pharmacology)ChairmanPh. (0712)2454687


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


D.N.B. (PulmonaryMedicine)

Reminder card Instructions in Translated from English to Hindi on 01Ph: (0712)2226219 25. Hindi March 2010

Dr. Mrs. S. ParanjapeMD, Physician

Reminder card Instructions in Translated from Hindi to English on 01(M) 9890445496 26.Hindi ( Back translation) March 2010

Dr. Jayesh TimaneM0, Physician

Reminder card Instructions in Translated from English to Marathi on(M) 9823584876 27. Marathi 26 Feb 2010

Dr. V. Ridhorkar-MCh, Urologist

Reminder card Instructions in Translated from English to Marathi on(M) 9373101536 28. Marathi( Back translation) 26 Feb 2010

Mrs. Liza FirdosiB.Pharm, MBA,

Reminder card Instructions in Translated from English to Urdu on 26Pharmacist, 29.(M) 9822941812

Urdu Feb 2010

Adv. S.W. MaruskarReminder card Instructions in Translated from English to Urdu on 02

LLB, Lawyer 30. Urdu( Back translation ) Mar 2010(M) 9370999234

Ms. Shilpa Agrawal Blank Case report form(AIi is" Feb 2010MSc, Counselor 31. visits)(M) 9890627404

Mr. Rajendra Jain Blank Case report form(AII 16thFeb2010Community Rep. 32. visits sub)(M) 9823176485

33. Investigator's Undertaking Dated: 2ih Feb 2010

INDEPENDENT ETHICS COM~IITTEE(NAGPUR



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]

REGD. OFFICE:

MEMBERS.

Dr. R. SwamakarD.N.B. (PulmonaryMedicine)Ph: (0712) 2226219


Dr. Jayesh TimaneMO, Physician(M) 9823584876





Mr. Rajendra JainCommunity Rep.(M)9823176485

Sr.No.

34.

35.

36.

37.

38.

39.

II

, Version Number and Version DateDocuments

At the "Independent Ethics Committee, Nagpur "meeting held on 19Jun 2010

at 6.00 pm at C/o Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli,

Nagpur-440012, the above mentioned documents were examined, reviewed and

discussed.

Acknowledgement ofsubmission letter to regulatoryauthorities (DCGI)

9-Mar-10

Curriculum Vitae(CV) ofPrincipal investigator Dated: zs" Jan 2010

Insurance Certificate Dated:06th April 2010

TriaI205.452:lmportantinformation

N.A.

Blank electronic Case reportform - eCRFs(AIi visits)

Version 1.0 dated 12th March 2010

Blank electronic Case reportform - eCRFs (All visits.sub)

Version 1.0 dated 12'h March 2010

The members who attended the meeting at which your study proposal was

discussed are as follows:

INDEPENDENT ETHICS COMMITTEE,NAG PUR



REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTEc/o Navjeevan Nursing Home, 20/1, Dr. Khare Marg, Dhantoli,Nagpur- 440012, TEL: 0712-6632200, 6632240FAX: 0712-2441046,2461249 email: [email protected]

MEMBERS:

Dr. R. SwarnakarD.N.B. (PulmonaryMedicine)Ph: (0712) 2226219


Dr. Jayesh TimaneMD, Physician(M) 9823584876




Ms. Shilpa AgrawalMSc, Counselor(M)9890627404

Mr. Rajendra JainCommunity Rep.(M)9823176485

s-, Name of the Role in the EC Qualification Affiliationno, member

1. Dr. A.G. Chairperson(Medical MD, NoShembekar Scientist) PharmacologyDr.Praveer

2. Waradkar Secretary MD, Psychiatrist No

Mrs. Lisa B. Pharm, MBA,3.. Firdosy Member Pharmacist No

4. Dr Mrs S Clinician MD, Physician YesParanjapeAdv. S.W.

5. Maruskar Legal expert LLB, Lawyer No

Social worker/Social scientist!

Mrs. Shilpa Representative of

6. Agrawal non - governmental MSc, Counselor Novoluntary agency/Philosopher/Ethicist! Theoloqian/Similar person

Mr. Rajendra7. Jain Lay person Mcom No

We approve the trial to be conducted in its presented form. The approval is valid

for entire period of the study. The approval is valid only after the regulatory

approval fram the Drugs Controller General of lndia has been obtained.

We hereby confirm that neither you nor any of your study team members have

participated in the voting/ decision making procedure of the committee. The

members of the committee who have participated in the votingt d.ecision making

Dr. A.G. ShembekarMD.(Pharmacology)ChairmanPh: (0712)2454687

INDEPENDENT ETHICS CO~1MITTEEtNAGPUR

Dr. Praveer WaradkarMO, Psychiatrist

Member Secretary(M) 9373107196

REGD. OFFICE: GETWELL HOSPITAL & RESEARCH INSTITUTECIO Navjeevan Nursing Home, 20/1, Or. Khare Marg, Ohantoti,

Nagpur - 440012, TEL: 0712-6632200,6632240FAX: 0712-2441046,2461249 email: [email protected]

ME - RS:procedure of the committee do not have any conflict of interest in the referenced

Dr. Rajesh Swarnakar study.D.N.B. (Pulmonary Medicine)Ph: (0712) 2226219

Dr. Jayesh TimaneMD, Physician(M)9823584876



Mrs. Liza FirdosiB.Pharm, MBA,Pharmacist,(M) 9822941812



Mr. Rajendra JainCommunity Rep.(M) 9823176485

The Independent Ethics Committee, Nagpur expects to be informed about:

1. The progress of the study annually.

2. Any SAE occurring in the course of the study.

3. Any changes in the protocol and patient information/informed consent.

Also you are requested to provide a copy of the final report.

This Ethics Committee is organized and operates according to Good Clinical

Practice and Schedule Y requirements.

Yours sincerely,

r.Praveer Waradkar

ember Secretary,ndependent Ethics Committee, Nagpur

Member SecretaryIndependent Ethics Clmmitter.

NAGPUR