Artemis Medicare Services Limited - Clinical Trials Registry

Date: 17th Feb.2010
To,
Dr. Anil Dhall,
Director & Head of Cardiology,
Artemis Health Institute,
Sector-51, Gurgaon-122001,
Haryana
Subject: Approval Letter.
Dear Dr. Dhall,
This is to inform you that the ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEW
BOARD in its meeting held on os" Feb. 2010 at 15:00 at conference room, 2nd floor, Artemis Health
institute reviewed, discussed and unanimously agreed to approve the conduct of clinical trial entitled
"Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure.
A randomised double-blind placebo-controlled international multi centre study."
The following documents were reviewed.
Main Study
1. Investigator's Brochure, version 11, dated 30 January 2009
2. Main study Protocol CL3-16257-083, dated 18 June 2009
3. Main study Protocol Signature Page (copy)
4. Main study Patient Information and Consent Document, dated 18 June 2009, English version
5. Main study Patient Information and Consent Document, (translated from English to Hindi)
dated 27 July 2009, Hindi version + translation certificate.
6. Main study Patient Information and Consent Document (back translation Hindi to English),
dated 27 July 2009 + translation certificate
7. Patient Cards, dated 24 June 2009, English version
8. Patient Cards, (translated from English to Hindi) dated 25th July 2009, Hindi version +
translation certificate
9. Patient Cards (back translated Hindi to English) dated 25th July 2009, English version +
translation certificate
10. Signed and dated curriculum vitae (CV) of Principal Investigator (Dr. Ani! Dhall)
II. QOL Protocol Signature Page (copy)
12. QoL questionnaires(Hindi) + ENGLISH
13. Protocol for QoL study, Final version, dated 30 June 2009
14. Patient Information and Consent document for QoL Study, English Version, dated so" June
2009
15. Patient Information and Consent document for QoL Study, Hindi version, dated 11th August,
2009 + translation certificate
16. Patient Information and Consent document for QoL Study, English Version, (back translated
Hindi to English) dated 11th August 2009+ translation certificate
17. QoL Assistance note dated 9th October 2009
18. QoL Assistance note dated 9th October 2009 (translated from English to Hindi)+ Validation
Certificate
19. QoL Assistance note dated 9th October 2009 (back translated from Hindi to English)+
Validation Certificate
20. QoL help note dated 9th October 2009
21. QoL help note dated 9th October 2009 (translated from English to Hindi) + Validation
Certificate
22. QoL help note dated 9th October 2009 (back translated from Hindi to English) + Validation
Certificate
23. Certificate ofInsurance
Page 1 oE2
I
Artemis Medicare Services Limited
Artemis Health Institute. Sector 51. Gurgaon 122 00 I Haryana
Ph.: +91-124-6767999 Fax: +91-124-6767701 Emergency: +91-124-6767000
www.artemishospital.in
Registered Office: 414/ I. 4U,Floor. DDA Commercial Complex. District Centre. Janak Purl, New Delhi - I 10 058
24. DCGI submission acknowledgment Letter
25.
26.
27.
28.
29.
30.
Draft Investigator Study Agreement
Note on patient recruitment procedure
eCRF Version 1.4 dated 1911112009
Investigator's Undertaking Form as per Appendix VII of Schedule Y
Investigator list in India dated 18th September 09
DCGI approval letter dated 03rd Feb.2010.
The following members attended the IRB meeting for the review of this clinical study. This
satisfies the quorum necessary for such meetings of this IRB
S.No
Name ofthe Member
Gender
1
Mr. T.C.A.
Rangachari
Male
Designation
member
Chairperson
2
Dr. R.K.Mani
Male
Vice-Chairperson
3
Dr. Deepak Govil
Male
IRB-Secretary
4.
Dr. Reshma Basu
Female
Member
5.
Mr. Pramod Kohli
Male
Legal Advisor
6
Mr. Dinesh Bhasin
Male
Lay person
7.
Dr. Namita Jaggi
Female
Scientist
8.
Ms. Kristen
Female
NGO representative
9
Mr. Himanshu Baweja
Male
Pharmacologist
We confirm that you did not participate in the deliberations
not vote on the proposal for this study.
of the
of the IRB for this study and did
We approve the protocol amendment to be executed in its presented form.
The ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD expects to be
informed about the progress of the study, any SAEs occurring in the course of the study, any
changes in the protocol and patient information/informed consent, protocol deviations, requests
annual study reports and asks to be provided a copy ofthe [mal report.
The ARTEMIS HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD functions in
accordance with ICH and GCP guidelines and those laid down in the Ethical Guidelines for
Biomedical Research on Human Subjects by Indian Council of Medical Research New Delhi.
, ~f
Member Secretary, AHS- IRB
Artemis Health Institute, Gurgoan.
I
Artemis Medicare Ser1i~Iei1!1ited
Artemis Health Institute. Sector 51. Gurgaon 122 00 I Haryana
Ph. : +91-124-6767999 Fax: +91-124-676770 I Emergency: +91-124-6767000
www.artemishospital.in
Registered Office: 414/ 1,4'" Floor, DDA Commercial Complex, District Centre, Janak Puri, New Delhi - I 10 058