independent ethics committee, · pdf filedr.rajesh swarnakar d.n.b. (pulmonary medicine)...

INDEPENDENT ETHICS COMMITTEE, NAGPUR

Prof.Dr. A.G. ShembekarMD. (Pharmacology)Chairman(M) 9822578307

Dr. Rajesh SwarnakarD.N.B. (Pulmonary Medicine)Member SecretaryPh:(0712)2226219

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:

Dr. Praveer WaradkarMD,Psychiatrist(M) 9373107196

Dr. Jayesh TimaneMD, Physician(M) 9823584876

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

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

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

Ms. Shilpa AgrawalMSc, Counselor(M) 9890627404

Mr. Agnelo PintoB A, Lay Person(M) 9373284869

Ref.No. IEC/12/0331-02 Date: 02/Apr/2012

To,

Dr. Rajesh Swamakar

Getwell Hospital, 2011,

Kbare Marg, Dhantoli,

Nagpur- 440015 (India)

Ref Study No: D5896C00027

Study Title: "A 26 week, randomized, double-blind, parallel-group, active controlled, multi centre, multinational safety studyevaluating the risk of serious asthma-related events duringtreatment with Symbicort®, a fixed combination of inhaledcorticosteroid (ICS) (budesonide) and a long acting B2-agonist(LABA) (formoterol) as compared to treatment with ICS(budesonide) alone in adult and adolescent (~12 years of age)patients with Asthma."

Subject: Ethics Committee approval of study related documentsfor the referenced study.

Dear Dr.swamakar

With ref. to your letter to us dated 02/Mar/2012. The IndependentEthics Committee, Nagpur reviewed the study documents for theclinical trial entitled "A 26 week, randomized, double-blind,parallel-group, active controlled,multicentre, multinational safetystudy evaluating the risk of serious asthma-related events duringtreatment with Symbicort®, a fixed combination of inhaledcorticosteroid (ICS) (budesonide) and a long acting B2-agonist(LAB A) (formoterol) as compared to treatment with ICS

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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]

Mr. Agnelo PintoB A, Lay Person(M)9373284869

(budesonide) alone in adult and adolescent (?:12 years of age)patients with Asthma.' On 311Mar/2012 at 6.00 pm.MEMBERS:


The following documents were reviewed:


1. Clinical Study Protocol• Clinical Study Protocol, Edition Number 1, Dated 16 September2011• Clinical Study Protocol Administrative Change 1, Dated 28October 2011• Clinical Study Protocol Amendment 1, Dated 22 December 2011• Clinical Study Protocol Administrative Change 2, Dated 25 January20122. Investigators Brochure Symbicort pMDI, Edition No. 11,Dated 31 August 20113. Investigational Medicinal Product Dossier (IMPD)Symbicort pMDIIBudesonide pMDI Edition I. Dated 22September 20114. Adult Study Patient Information and Consent Form for useGlobally (except in the US)Master Version Number 2 Master Version Date 9 December 2011India Version Number 2 India Version Date 10 January 2012-

• English

• English to Hindi translated on 31 January 2012

• Engli sh to Marathi translated on 31 January 2012

• English to Urdu translated on 02 February 2012





• Hindi to English back translated on 31 January 2012• Marathi to English back translated on 31 January 2012• Urdu to English back translated on 02 February 2012.

5. Genetic Research Addendum to Informed Consent Formfor use Globally (except in the US) -Master Version Number 2 Master Version Date 9 December 2011India Version Number 2 India Version Date 10 January 2012

• English


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• English to Marathi translated on 23 January 2012

• English to Urdu translated on 23 January 2012• Hindi to English back translated on 23 January 2012• Marathi to English back translated on 23 January 2012• Urdu to English back translated on 23 January 2012

MEMBERS:

Dr. Praveer WaradkarMD,Psychiatrist(M)9373107196


•


6. Paediatric Study Patient Information and Consent Form foruse Globally (except in the US) -Master Version Number 2 Master Version Date 9 December 2011India Version Number 2 India Version Date 10 January 2012

• English



• English to Urdu translated on 28 January 2012• Hindi to English back translated on 28 January 2012• Marathi to English back translated on 30 January 2012• Urdu to English back translated on 28 January 20127. Paediatric Genetic Study Subject Assent Form-Master Version Number 2 Master Version Date: 9 December 2011India Version Number 2 India Version Date: 10 January 2012

• English



• English to Urdu translated on 17 January 2012




• Hindi to Engl ish back translated on 17 January 2012• Marathi to English back translated on 17 January 2012• Urdu to English back translated on 17 January 2012

8. Paediatric Genetic Research Addendum to InformedConsent Form for use Globally (except in the US) -Master Version Number 2 Master Version Date 9 December 2011India Version Number 2 India Version Date 10 January 2012• English

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Dr. Rajesh Swarnakar. D.N.B. (Pulmonary Medicine)Member SecretaryPh:(0712)2226219

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. Praveer WaradkarMO,Psychiatrist(M)9373107196

• English to Hindi translated on 23 January 2012• English to Marathi translated on 23 January 2012• English to Urdu translated on 23 January 2012• Hindi to English back translated on 23 January 2012• Marathi to English back translated on 23 January 2012• Urdu to English back translated on 23 January 2012Dr. Jayesh Timane

MO, Physician(M)9823584876 9. Pediatric Study Subject Assent Form

Master Version Number 1Master Version Date: 16 September 2011India Version Number 2 India Version Date: 10 January 2012• English• English to Hindi translated on 18 January 2012• English to Marathi translated on 18 January 2012• English to Urdu translated on 18 January 2012• Hindi to English back translated on 18 January 2012• Marathi to English back translated on 18 January 2012• Urdu to English back translated on rs January 2012

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



10. Supplement to Adult Study Subject Information andConsent FormMaster Supplement Version Number 1 Master Supplement VersionDate 11 January 2012India Supplement Version Number 1 India Version Date 23 January2012• English• English to Hindi translated on 02 February 2012• English toMarathi translated on 10 February 2012• English to Urdu translated on 09 February 2012• Hindi to English back translated on 02 February 2012• Marathi to English back translated on 10 February 2012• Urdu to English back translated on 09 February 2012



11. Supplement to Pediatric Study Subject Assent FormMaster Supplement Version Number 1Master Version Date:l l January 2012India Version Number 1 India Version Date: 23 January 2012• English• English to Hindi translated on 10 February 2012• English to Marathi translated on 10 February 2012

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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]


• English to Urdu translated on 13 February 2012• Hindi to English back translated on 10 February 2012• Marathi to English back translated on 10 February 2012• Urdu to English back translated on 13 February 2012

MEMBERS:

Dr. Praveer WaradkarMD, Psychiatrist(M)9373107196



12. Supplement to Paediatric Study Subject Information andConsent FormMaster Supplement Version Number 1 Master Supplement VersionDate 11 January 2012India Supplement Version Number 1 India Version Date 23 January2012• English• English to Hindi translated on 02 February 2012• English to Marathi translated on 10 February 2012• English to Urdu translated on 09 February 2012• Hindi to English back translated on 02 February 2012• Marathi to English back translated on 13 February 2012• Urdu to English back translated on 09 February 2012



13. LABA Asthma Control Questionnaire:


• English Version for India Question 1 to 6,January 2007, Modifiedversion date August 2011• Hindi Version Question 1 to 6, December 2002, Modified versiondate August 2011• Marathi Version, Question 1 to 6, January 2007, Modified versiondate August 2011• Urdu Version for India Question 1 to 6, 2011, Modified versiondate June 2011

14. LABA pMDI Instructions: Rev. SEP 2011• English• English to Hindi translated on 25 November 2011• English to Marathi translated on 25 November 2011• English to Urdu translated on 25 November 201115. LABA Study Participation Card, Version 1, July 2011,India Version 1.0 dated 23 November 2011

• English

• English to Hindi translated on 06 December 2011

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• English to Marathi translated on 06 December 011


MEMBERS:


,.• English to Urdu translated on 06 December 2011


16. LABA ePRO Ethic Prompt List

• English

• English to Hindi

• English to Marathi

• English to Urdu



17. LABA Patient Pamphlet

• English Version 1

• English to Hindi dated 03 November 2011 Fina

• English to Marathi 03 November 2011 Final

• English to Urdu 07 November 2011 Final18. eCRF19. DCGI Submission Acknowledgement Letter20. Principal Investigator's Letter ofUnderta~ing (AppendixVII) I

21. Curriculum Vitae for Principal Investigatlrs22. Insurance Certificate23. Clinical Study Agreement Draft24. Translation and Back Translation Certificates25. GCP certificate of PI I

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


The following members of the Ethics Committee were present atthe meeting held on 31/Mar/2012 at 6.00 pm at C/o NavjeevanNursing Home, 2011, Dr. Khare marg, Dhantoii, Nagpur 4400l2.Thequorum met as per ICH-GCP and schedule Y.

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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]


Name M I Qualification Designa Sl Affiliation Contact NoF tion NS to the

InstituteDr.A.G M Pharmacologist Chairman S No 9822578307Shembekar

*Dr.Praveer M M D,psychiatrist Member s No 9373107196Waradkar Secretary

Dr.Mrs.S. F Physician Member S Yes 9890445496Paranjape

Adv.S.W. M LLB, Lawyer Member NS No 9370999234Maruskar

Ms.Shilpa F M.Sc(Human Member NS No 9890627404Agarwal Development),

Social Worker &Counselor

Mr. Agnelo M B.A, Lay person Member NS No 9373284869Pinto

MEMBERS:

Dr. Praveer WaradkarMD,Psychiatrist(M)9373107196

Dr. Jayesh TimaneMO, Physician(M) 9823584876

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




We approve the trial to be conducted in its presented form. Wehereby confirm that neither you nor any of your study team members

have participated in the voting/ decision making procedure ofthecommittee. The members ofthe committee who have participated in

the voting decision making procedure of the committee do not have

any conflict of interest in the referenced study. The independent

ethics committee, Nagpur is ICH-GCP and Schedule Ycompliant.

The Independent Ethics Committee, Nagpur expects to be informed

about:

1.The progress of the study yearly.

2. Any SAEoccurring in the course ofthe study.

3. Any changes in the protocol and patient information/informedconsent.

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

MEMBERS:

Dr. Praveer WaradkarMD, Psychiatrist(M)9373107196


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

*Note: - For this EC meeting, Dr.Praveer Waradkar acted asmember secretary instead of Dr. Rajesh Swamakar. Dr RajeshSwamakar was not a part of decision making process.


Yours Sincerely,

~\~ -,~ '1.~'1'2-·

DrAG.Shembekar

Chairm8i'ilIndependent Ethics Committee \

NAGPUR

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

Chairman

Independent Ethics Committee,Nagpur


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