10- C..5P-'J>T) · 2012-02-28 · Dr. Jatin Kothari P. D. Hinduja National Hospital and Medical Research Center, Veer Savarkar Marg, Mahim, Mumbai - 400016. India. Study Title: A

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~P. D. Hinduja National Hospital & Medical Research Centr~.JA

(Established and managed by the National Health & Education Society)Reg No. F-452 (BOM) : [under the Bombay Public Trust Act]

CLINICAL RESEARCH ETHICS COMMITTEE (CREC)

APPROVAL LETTER

17th June 2010

To,

Dr. Jatin KothariP. D. Hinduja National Hospital and

Medical Research Center,Veer Savarkar Marg,Mahim,Mumbai - 400016. India.

Study Title: A Phase III, Randomized, Comparative, Open-label Study ofIntravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions orRepeated Bolus Injections in Comparison with Oral Iron Sulphate in Subjects withNon-Dialysis Dependent Chronic Kidney Disease and with Renal-Related Anaemia.

Protocol Iden ifier: P-Monofer- CKD-02

Subject: Ethics Committee Approval for the study conduct

Reference: EC query letter dated 15 February 2010

EC response letter

Dear Dr. Kothari,

The Clinical Research & Ethics Committee has reviewed and discussed yourapplication to conduct the clinical study on 5th February 2010 at P. D. HindujaNational Hospital and Medical Research Centre, Mumbai

Address: her Savarkar Marg, Mahim, Mumbai - 400016Telephone. +91 ~p2445 2222/24451515/24449199 EXT 7195/7196

Direcfi +91 222444 7622 Fax: +91 222444 7490E-mail: [email protected][email protected]

,

P. D. Hinduja National Hospital & Medical Research cent~J4 ~!~~~(Established and managed by the National Health & Education Society)

Reg No. F-452 (BOM) : [under the Bombay Public Trust Act]

S. No. Documents Version No. / DateI

Protocol (with signature page) with

1 Cambridge-Hopkins Restless Leg Document Version: 2.0Syndrome Questionnaire (English) Dated 01 December 2009

Cambridge-Hopkins Restless LegI

2 Syndrome Questionnaire - Hindi,NA

\

Marathi, Gujarati

3aQuality of life Questionnaire - Linear

NAAnalogue Self Assessment (English)

Quality of life Questionnaire - Linear3b Analogue Self Assessment ( Hindi, NA

Marathi, Gujarati )I

Date: 16 Dec 2009

4 Insurance CertificatePolicy Number: OG-l0-1113-3396Validity: 01 Jan 2010 to 31 Oct

\2011

I5 DCGI submission letter Date 14 Dec 2009

6

Investigator Undertaking dated 12 November 2009

Investigator Brochure Document Version: 4.0Dated 26 November 2009

7 Draft Clinical Trial Agreement

8

The following documents have been reviewed and approved:

Address: Veer Savarkar Marg, Mahim, Mumbai - 400016Telephone: +912224452222/24451515/24449199 EXT: 719517196

oired +91 222444 7622 Fax: +91 222444 7490E-mail: [email protected][email protected]

II

P. D. Hinduja National Hospital & Medical Research cent~1J)(;"A~t:~~(Established and managed by the National Health & Education Society)

Reg No. F-452 (BOM) : [under the Bombay Public Trust Act]

9

10

l1a

l1b

llc

l1d

Site Specific Informed Consent Form (SSICF) in Hindi forward and backwar j

Translations

Global ICF 09 November 2009, Version-l

India ICF 15 November 2009, Version-1

Site Specific Final (English to Hindi) ICF 17 November 2009, Version-1

Principal Investigator CV & MRC dated 12 November 2009

Ethics Committee Cheque dated 29th December 2009 for Rs. 20,000/-

Site Specific Informed Consent Form (SSICF) in English:

Global ICF 09 November 2009, Version-1


Site Specific ICF 16 November 2009, Version-1

Site Specific Informed Consent Form (SSICF) in Hindi forward and backwarc

Translations



Site Specific Final (Hindi to English) rCF 19 November 2009, Version-1

Site Specific Informed Consent Form (SSICF) in Hindi forward and backward

Translations


India rCF 15 November 2009, Version-1

Site Specific Final Hindi ICF 23 November 2009, Version-1

Address: Veer Savarkar Marg, Mahim, Mumbai - 400016Telephone: +91 2224452222/24451515/24449199 EXT. 719517196

Diredt: +91 222444 7622 Fax: +91 2224447490E-mail: [email protected][email protected]

~P. D. Hinduja National Hospital & Medical Research Centr~"4

(Established and managed by the National Health & Education Society)Reg No. F-452 (80M) : [under the Bombay Public Trust Act]

Site Specific Informed Consent Form (SSICF) in Marathi forward and

backward Translations

11e Global IeF 09 November 2009/ Version-1

India rcr 15 November 2009/ Version-1

Site Specific Final (English to Marathi) ICF 17 November 2009/ Version-1

1lf Global rcr 09 November 2009/ Version-1

Site Specific Informed Consent Form (SSICF) in Marathi forward and

backward Translations

India rCF 15 November 2009/ Version-1

Site Specific Final (Marathi to English) IeF 19 November 2009/ Version-1

11g

Site Specific Informed Consent Form (SSICF) in Marathi forward andbackward Translations

Global CF 09 November 2009/ Version-1

India _CF 15 November 2009/ Version-1

Site Specific Final Marathi ICF 23 November 2009/ Version-1

11h Global ICF 09 November 2009/ Version-1

India ICF 15 November 2009/ Version-1

Site Specific Informed Consent Form (SSICF) in Gujarati forward andbackward Translations

Site Specific Final (English to Gujarati) ICF 17 November 2009/ Version-1

11i GI bal rCF 09 November 2009/ Version-1

India rCF 15 November 2009/ Version-1

Site Specific Informed Consent Form (SSICF) in Gujarati forward andbackward Translations

Site Specific Final (Gujarati to English) ICF 19 November 2009/ Version-l

Aodress: Veer Savarkar Marg, Mahim, Mumbai - 400016Telephone: +91 2224452222/24451515/24449199 EXT: 7195/7196

Dired +91 222444 7622 Fax: +91 2224447490E-mail: [email protected][email protected]

P. D. Hinduja National Hospital & Medical Research cent~J.:---;:~~


Site Specific Informed Consent Form (SSICF) in Gujarati forward andbackwar Translations

llj Global _CF 09 November 2009, Version-l

India ICF 15 November 2009, Version-l .

Site Specific Final Gujarati ICF 23 November 2009, Version-l

The following members of the ethics committee were present at the meeting held on

5th February 2010at P. D. Hinduja National Hospital and Medical Research Centre,

Mumbai.

Name Designation/Title Affiliation

Dr. Atul Garud In chair No

Dr. V. R. Joshi (Member Secretary) Yes

Dr. Urmila Thatte Member No

Dr. A. Almeida Member Yes

Dr. V. Deshmane Member Yes

Dr. S. Morekar Member Yes

Dr. S. Iyer Medico-legal Consultant Yes

Mrs. Mona Patel Lay person No

Mrs. H. Joseph Social Scientist No

Mrs. S. Jaywant Member Yes

Dr. Nirupa Borges * Member No

* Invitee Member

Address: her Savarkar Marg, Mahim, Mumbai - 400016Telephone. +912224452222/24451515/24449199 EXT: 7195/7196

Direct! +91 2224447622 Fax: +91 2224447490E-mail: [email protected]/[email protected]

1iP. D. Hinduja National Hospital & Medical Research Cent~J.-~...-_"""


Kindly note that as per Ethics Committee suggestion CREC received following

8a English 16 February 2010, Version - 02

Forward translation ( 17 February 2010, Version - 02)

Backward translation (18 February 2010, Version - 02)8b Hindi Final (19 February 2010, Version - 02)

Forward translation ( 17 February 2010, Version - 02)

Backward translation (18 February 2010, Version - 02)8c I Marathi Final (19 February 2010, Version - 02)

II I

IForward translation ( 17 February 2010, Version - 02)

./Backward translation (18 February 2010, Version - 02)

8d

I

Gujarati Final (19 February 2010, Version - 02)

I

modified documents on 3 March 2010 & approved

CREC also notified following documents.

• DCGI approval letter dated 15 June 10

• E-CRF-Final version 1.0 dated 16 March 10

We approve the study to be conducted in its present form at P.D.Hinduja National

Hospital and Medical Research Centre, Mumbai with Dr. Jatin Kothari as the

Principal Investigator.

Address:feer Savarkar Marg , Mahim , Mumbai - 400016Telephone: +91 224452222/24451515/24449199 EXT. 7195/7196

Diree.' +91 222444 7622 Fax: +91 222444 [email protected]/[email protected]

P. D. Hinduja National Hospital & Medical Research centl~,J.~~""'-::-..N


This is to confirm that neithe Dr. Jatin Kothari (PI) nor any other study staff

participating in this study was involved in the Clinical Research & Ethics

Committee decision making including voting procedures, while granting the

permission this study.

The Project is approved in its presented form. The approval is valid untilone year fro_ the date of this letter of approval. for renewal/extensionof the study you are requested to submit a written application along withthe submission of annual status report).

Followin oi t m s • e noted:

1. Ethics committee (EC) should be informed of the yearly progress in the formof annual report of the study {annual report format as given in IRB/CREC SOP or it can be obtained from Researchdepartment.

2. EC has approved recruitment of 10 number of patients on this study.

3. It is essential that all patients included in research studies should have an H.H. No. They could, if necessary be registered as Free OPD patients.

4. Outside patients must be registered at Hinduja Hospital (free OPD) Moneyfrom incidental expenses, can be used for this purpose

5. Hinduja Hospital research patient files (MRD files) must have RED label toidentify them as research patients.

6. If the company has sponsored the project, all the cheque should be drawn inthe name of "National Health and Education Society".

7. In case of sponsored projects it is essential that the sponsors pay advance intime.

8. The usual procedures for utilization of funds sanctioned for the project shouldbe followed and patients covered by the study, if any, should not be chargedfor relevant items/investigations (related to the study).

9. All requests for investigations advised to the patients covered by the studyshould be accompanied by a vo cher request form (format available withresearch department). You should get the voucher request form signed andapproved in advance by Director Research. Please note this is essential andNo voucher will be generated without the producing duly approved voucher

Address.· Veer Savarkar !VIarg, Mahim , Mumbai - 400016Telephone. +91 2f 2445 2222/24451515/2444 9199 EXT 7195/7196

Direct +91 222444 7622 Fax: +91 222444 [email protected][email protected]

P. D. Hinduja National Hospital & Medical Research Centl~;-..,.....~AV"4


request form at the reception counter. Only those investigations, which arepertinent to the project and mentioned in your research proforma should beasked for.

10. Kindly ensure that every consultation/ investigation voucher generated forresearch patie ts must contain project code number. This project number isinserted by the receptionist (in remark column) before generating voucher.This is essential for accounts.

11. If a research fellow / technician is to be appointed on the research project,please firs process the approved application of the candidate through theresearch department which will then be forwarded to the HR department. Theconcerned person will/can start working on the project only after'Appointment Order' is issued.

12. If yo have a Research Fellow assigned to your project, he/she should punchthe -D card daily. If he/she wishes to proceed on leave an application for thismust e submitte by him/her to this office duly signed by the PI.

13. At the end of the study all documents are to be handed over to researchsociety. These will be retained for as per the regulations.

14. As required by ICH-GCP & ICMR guidelines for good clinical practice. ClinicalTrial Monitor designated by research department will periodically visit thetrial/study sites with prior intimation to you to review the projects

15. In case of PI's retirement/ leaving the institute, study responsibility should betransferre to the Co-investigator after obtaining clearance from EC.

16. The CREC functions in accordance with the ICH-GCP/ICMR/Schedule Yguidelines.

17. In case of any new information or an SAE, which could affect the study, itmust be informed to EC, The PI should report SAEs to EC within 7 days of theoccurrence of the SAE. If the SAE is 'Death', the EC (IRB/ CREC) Secretariatshould receive the SAE reporting form within 24 hours of the occurrence.

18. (Please keep the SAE reporting form with you. This is available with researchdepartment)

19. In the event(s) of any protocol amendments, EC must be informed and onlyafter approval the amendment(s) then can be implemented. Amendmentsshoul be highlighted in c ear terms as follows:

Address: Veer Savarkar Marg, Mahim, Mumbai - 400016Telephone: +91 2224452222/2445 1515/2444 9199 EXT: 7195/7196

Direct" +91 222444 7622 Fax: +91 222444 7490E-mail: [email protected]/[email protected]

P. D. Hinduja National Hospital & Medical Research centr~.JA


a. The exact alteration/amendment should be specified and indicatedwere the amen ment occurred in the original project. (Page no.Clause no. etc.)

b. Alteration in the budgetary status should be clearly indicated and therevised budget form should be submitted

c. If the amendments require a change in the consent form, the copy ofrevised Consent Form should be submitted to Ethics Committee forapproval.

d. If there are any amendments in the study design, these must beincorporated in the protocol, and other study documents. These.evised documents should be submitted for approval to the EC.

e. Approval of amendment changes must be obtained prior toimplemen .atlon of changes. Without including all the above points, theamen ment is unlikely to be approved by the Ethics committee.

f. Any deviatiori/vlolatlon/waiver in the protocol must be informed to theEC i the reportlnq form (available with the research department).

All the above instructions/ procedure should be followed strictly without exception.

Please feel free to contact the undersigned if you have any queries concerning theproject.

This approval for the study will be valid after the notification of the followingdocuments t t e Ethics Committee:

• The signed Clinical Trial Agreement for the Study

Thanking You,

Yours Sincerely,Dr. V.R. JoshiMember SecretaryNational Health & Education SocietyClinical Research & Ethics CommitteeP.O. Hinduja National Hospital& Medical Research Centre,Veer Savarkar Marg, Mahlm,Mumbai ~ 400 016.

~

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Dr. :-- .. Joshi

Member Secretary

Address: Veer Savarkar Marg, Mahim, Mumbai - 400016Telephone: +91 2224452222/2445 1515/2444 9199 EXT: 7195/7196

Direct +91 2224447622 Fax: +91 2224447490E-mail.·[email protected]/[email protected]