MAULANA AZAD MEDICAL COLLEGEAnd

Associated Lok Nayak, Govind Ballabh Pant Hospital,Guru Nanak Eye Centre, New Delhi -110002

(Institutional Ethics Committee)F.2/IEC/MAMC/ll1 0 \"k':l..Dated: ,.;> \ ~ \ ~t>\\

To,

Dr N.GuptaDir. Prof. of MedicineMaulana Azad Medical college &Associate Lok Nayak Hospitali cw Delhi-Il 0002

Ref: B-LONG: 998HB I02: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, andEfficacy of Recombinant, Long-acting Coagulation Factor IX Fe fusion (rFJXFc) in the Prevention andTreatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B

Dear Dr. N.Gupta,

With reference to your Submission letter dated 25/04/11 the Institutional Ethics Committee reviewed anddiscussed your application for conduct of clinical trial on 02/05/20 II

The following documents were reviewed:

IS. sNo. I Document/Language Documen t Details/V crsions I

f '1':---+ PmiocOi"Amendment (along with 998HB 102 Protocol Amendment 3.0 dated 01 SeptemberI I Summary) 2010,

[ 2. . -!lrWestigator Brochure IB Version 3.0 dated 05 August 20 I0--

L---·-I-i 3. I Site Specific English Parent Patient Maul ana Azad Medical Col lege specific Patienti I Information (Parent consent) information sheet and ICF: Version 3. I dated 20 AprilI

i 20 II (Parent Consent)r

----- -3a Site Specific Hindi Parent Patient Maulana Azad Medical College specific Patient

Information (Parent consent) information sheet and ICF: Version 3.1 dated 20 April2011 (Parent Consent), translated from English to Hindi on20 April 20 II-Maulana Azad Medical College specific Patient3b Site Specific Parent Patient

Information, back translated from information sheet and ICF: Version 3.1 dated 20 AprilHindi to English (Parent consent) 2011 (Parent Consent), back translated from Hindi to

English on 20 April 20114. Site Specific English Patient Maul ana Azad Medical College specific patient

Information Sheet (Adult Consent) information sheet and ICF: Version 3.1 dated 20 April

- 201 I (Adult Consent)

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4a Site Specific Hindi Patient Information Maulana Azad Medical College specific patientSheet (Adult Consent) information sheet and lCF: Version 3.1 dated 20 April

2011 (Adult Consent), translated from English to Hindi on20 April 20 II

I 4b Site Specific Patient Information Maul ana Azad Medical College specific patientI Sheet, back translated from Hindi to information sheet and ICF: Version 3.1 dated 20 April

English (Adult Consent) 2011 (Adult Consent). back translated from Hindi toEnglish on 20 April 2011

5. Site Specific English Patient Assent Maulana Azad Medical College Specific Patient Assent:form Version 3.1 dated 20 April 2011

Sa Site Specific Hindi Patient Assent Maulana Azad Medical College Specific Patient Assent:form Version 3.1 dated 20 April 2011, translated from English to

Hindi on 20 April 20 I ISb Site Specific Patient Assent form, back MauJana Azad Medical College Specific Patient Assent:

translated from Hindi to English Version 3.1 dated 20 April 2011, back translated fromHindi to English on 20 April 2011

6. ePRO-LOG Subject Diaries in ePROLOG_SubjectGuideI02_en_fN_en_ZA_26 Oct 10English

6a ePRO-LOG Subject Diaries in Hindi ePROLOG_SubjectGuide I02_hi_fN_25JunlO in Hindi

7 . Subject Questionnaire - English Subject Questionnaire version dated 19 Jan 2010

. -7<1 Subject Questionnaire - Hindi Subject Questionnaire version dated 19 Jan 2010,

translated from English to Hindi on 31 March 2010

8. Patient Identification Card - English Patient Identification card version 1.0 Dated 05 Jaw20 10

8a Patient Identification Card - Hindi Patient Identification card version 1.0 Dated 05 Jan 2010,translated from Engl ish to Hindi on 30 March 2010

9. Information for the patient Information for the Patient, version 1.0 dated 15 Jan 2010

r- 9a Information for the patient in Hindi Information for the Patient, version 1.0 dated 15 Jan 2010,translated from English to Hindi on 22 Jun 2010

10. e-Diary Script (shell, Syn, Enrollment, e-Diary Script (shell, Syn, Enrollment, Training, Quiz,Training, Quiz, Injection log, Injection log, Reminders, Errors, Subject guide', version 05

-- Reminders, Errors, Subject guide) Oct 20 lOin EnglishlOa e-Diary Script (shell, Syn, Enrollment, e-Diary Script (shell, Syn, Enrollment, Training, Quiz,

Training, Quiz, injection log, Injection log, Reminders, Errors, Subject guide, version 05Reminders, Errors, Subject guide) Oct 2010, translated from English to Hindi on 11 October

201011. Haerno-Qol, for Childrens and © Haemo-Qol, Children III - English/UK - Version of 18

Adolescents in English Jul08

12. Haerno-Qol, for Adults in English © Haem-A-QoL Adults - Engl ish/UK - Version of 18 J ul08

13. Insurance Certificate India Specific HDFC ERGO - SER Clinical TrialsInsurance Policy, val id from 25 Feb 2011 - 24 Feb 2012

-

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--14. Import license Import license no. T-7177/10 dated 27 Aug 10

14a Import license amendment Import license amendment dated 30 Sep 2010

15. ExportNOC Export NOC dated 27 Aug 2010

16. DCGI Approval for Amendment 2 DCGI Approval dated 27 Aug 20 I0

17. DCGI Approval for Amendment 3 DCG I Approval dated 16 Mar 20 II

18. DCGI approval for additions of the site DCGI approval dated 06 April for additions ofthe site

19. Current Curriculum Vitae ofDr. Naresh Gupta

20. Investigator Undertaking by Signed on 19 Jan 2011Dr. Naresh Gupta

21. Draft CTA

22. Financial Disclosure of the Financial Disclosure of Dr. Naresh Gupta (PI) signed on 20Investigators Apr 2011.

Financial Disclosure of Dr.Ashok Mittal (Co-I) signed on20 Apr 2011

At the· Institutional Ethics Committee Meeting held on 02/05111 the above mentioned documentswere examined & discussed. The clarifications submitted by you on 08/09/1 I have been accepted and thecommittee has decided to approve the documents and the conduct of the trial in the presented form.

The clinicians in the quorum have experience of treating patients in Paediatric group also. The opinion forthe study has been given by them considering all ethical and clinical issues related to Paediatric group.

The Institutional Ethics Committee has working procedures in compliance with ICH-GCP Guidelines,

Schedule Y guidelines and ICMR Guidelines,

Promptly report to this Ethics committee in case of:-

I. Any deviation or change to the protocol approved by this ethics committee that you may

implement to eliminate immediate hazards to subjects

II. All serious adverse events

III. New information that may affect adversely the safety of the subjects or the conduct of the trial.

IV. It is understood that the study is being conducted under your direction at Maulana Azad MedicalCollege & Associated Lok ayak Hospital ,Govind Ballabh Pant Hospital and, Guru Nanak EyeCentre, Bahadur Shah Zafar Marg, New Delhi - 02.

v. It is also to inform you that the financial transactions of the drug trials and non-governmentsponsored studies will be routed through MAMC society for promotion of Medical Research only

Vi. A report of the study should be sent to the Ethics Committee annually

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..

The following members of the Ethics Committee were present at the meeting held on 2nd May 2011 at2:00 PM in the MAMCOS conference room, 3rd floor Room no. 309, Maulana Azad Medical College,ew Delhi-l 10002

Name of the Member Designation & Affiliation

I. Dr. A.S.Bais2. Dr. M.M.Mehndiratta

Chairperson, Ex- Principal, LHMCMember Secretary, Dir.Professor, Department of Neurology, GBPH

Members:-

3. Mr. S.N.Sinha,4. Mr. R.K. Prabhakar5. Mr. L.D. Kashyap6. Dr. N.P. Singh7. Dr. Daljit Singh8. Dr. Sabita Mishra

Member Press Council of India, ( Media representative)Legal AdvisorSocial Worker, Community Medicine ,MAMCDir. Professor Department of Medici ne & Member, LNHProfessor, Department ofNeurosurgery& Member, GBPHProfessor, Department of Anatomy, MAMC

Or. V.K.Gupta ,Prof. ofP&SM, Dean's representative authorised signatory for Clinical trial agreement

lhis is to confirm that only members who are independent of the Investigator and the Sponsor of the trialhave votecl/ provided opinion on the trial.

Yours,

4)/(Dr. M.M.Mehndiratta)Member SecretaryInstitutional Ethics Committee

Date:

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