The following documents submitted for the above-mentioned clinical project were
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1 MEDICAL JehaI Date: 26'" Jul 2010 To Dr.Shrikant Wagh JCDC Pvt Ltd, Jehangir Hospital Premises Pune , Dear Dr. Wagh The Institutional Ethics Committee (Hirabai Cowaqi Jehangir Medical Research Institute And Jehangir Ethics Committee) reviewed and discussed your application to conduct the clinical trial Protocol A entitled "Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate- Naive Patients with Rheumatoid Arthritis" on 17m Jul 2010, at Conference Hall, JCDC between 11:30 to 13:00 The following documents submitted for the above-mentioned clinical project were reviewed 1. Protocol Amendment 1, Version dated 15 December Protocol Administrative Changes document dated 08 February Protocol Administrative Changes document dated 24 February Protocol Amendment 3, Version dated 05 May Protocol Administrative Changes document dated 02 June Molecular Profiling Supplement: Samples for Pfizer's Exploratory Research Biobank Version 10 November Part I-informed Consent Document Version 11 May 2010 in English and translations in Hindi, and 8. Part Ii-informed Consent Document- Consent for Additional Procedure: Donation of Samples to be Banked for Exploratory Research version 18 December 2009 in English and translations in Hindi, and 9. Exposure in Ulero Pregnant Partner Release of information Fomn Version 17 July 2006 (Customized for india on 26 Apnl 20t0) in English and translations in Hindi, and 10. Investigator's Brochure Version July 2009.lellan~ii- Ctillic;ll L)ciclol,lllcnr Cenlle L:thiur (:ornniilrce lellangir ih,ipitai I'I-clnicr.?2. SaiE~on Ilo;id. Pune --JI ICK)I Ph r)-2605~~1Y i;sl -- tol -2L)-Zhi15v3 19
2 MEDICA ~eha?gir 11. Erratum 1 (August 2009) to the investigator's Brochure of July Blank Case Report Form Version 01, dated 12 January EQ-SD Health Questionnaire in English and translations in Hindi. and 14. Facit-Fatigue scale (Vecsion 4) in English and translations in Hindi, and 15. Health Assessment Questionnaire (HAQ) Disability index in English and translations in Hindi. and 16. Medical Outcomes Study Sleep Scale (MOS) in English and translations in Hindi, and 17. Patient Assessment of Arthn'tis Pain Scale in English and translations in Hindi, and 18. Patient Global Assessment of Arthritis (VAS) Scale in English and translations in Hindi, and 19. Rheumatoid Arthritis Healthcare Resource Utilization Questionnaire in English and translations in Hindi, and 20. SF36v2 Health Survey in English and translations in Hindi, and 21. Work Limitations Questionnaire (WLQ) in English and translations in Hindi, and 22. Physician Assessment in English 23. Dosing Diary Version 1, dated 15 December 2009 in English and translations in Hindi, and 24. Insurance policy I compensation for serious adverse events occum'ng during the study participation las per agreement and informed Consent Document) 25. Copy of investigator Undertaking 26. Principal investigator's cunent CV 27. DCG(I) acknowledgement dated 31 March 2010 for Trial Application 28. Draft copy of Study Agreement 29. Patient ID Card for use to be given to the patients Jchaneir Clinicai Ds\;clopment Ccntre I:thics Committee Ichangil- Ilospi:al I'l clniscr;, 32, Sa~soon R~liid. Pllnc- 41L001 Ph Fnx--191?0-Zh05~)] 9
3 MEolcn leha?gir 1 ; In this study, patients will be given ID cards at the time of baseline visit after randomization (enclosed for your reference). This ID card has information such as patients name/contact details, identification as a study participant and serves as a reference to any other physician/consultant for them to itnow and contact the site and principal investigator. Besides this, there is no other study related information on this ID card. As per ICH-GCP guideline any document given to the patient may require EC approval. We have also been notified the DCGI approval letter We also approve the following: 1. Methods of patient accrual: ~ Patients visiting our hospitallinstitute OPD Refened patients from p~mary health care centrelprivate practitioners through verbal communication and discussion 2 patient travelrelmbursement: Patients coming to site from the same city or from nearby towns/places: based on actual cost incurred while travelling by their usual mode of transport but not exceeding _ pervisit. Patients coming to site from distant cities/towns/places: based on actual cost incurred while travelling by their usual mode of transport but not exceeding per visit. In case a higher amount is required to be paid to a patient as an exception, the same will be notified to Ethics Committee with justification. The Ethics Committee acknowledges that the following central laboratories will be used for all protocol specined investigations in the study- Name and address of the central laboratory where the specimens will be sent from site forprotocol specific laboratory investlgetlons: Covance Central Laboratory Services f International Business Park #05-12A/8 The Synergy Singapore Name and address of the facility where Covance will be sending the DNA, and Molecular Profiling specimens for exploratory research (DNA and MP samples will 6e sent to Covance in Singapore from she and then to Pflzw for analysis): Diane Johnson do King Heights DNA and Biofluids CoE Pfizer Global Research and Kings Heights Technology Center, 23 Kings Highway Groton, CT Name and address of facility where the PK samples will be sent (PK Samples will be sent to Covance In Singapore from site and then to BASI for analysis): sasi (sioanalyticai Systems, inc), Jcha~lEir Clioical I)cvclopmeet Cenbe Etbics C.ommitter Tshangir Hospital I'I emiscz, 32; Sassoon Iload. Pune - J Fh ( IR Fax-t91-?0-2h059)IP
4 MEDICA H leh.a?gir 2701 Kent Avenue, West Lafayette, IN Name and address of facility where hands and feet radiographs will be sent for Joint Structure Preservation end point assessment: Synare Hamburg PlizerA Team Luebecker Strasse Hamburg. Germany The following local laboraories will be used for the study- Jehangir Hospital Laboratory Jehangir Hospital Pune Hirabai Cowasll Jehangir Medical Research Institute Laboratory Old Building Basement, Jehangir hospital, Pune Department of Radiology Jehangir Hospital, 32,Sassoon Road, Pune The members who attended the meeting held on 17n Jul 2010, at Conference Hall, JCDC between 11:30 to 13:00 hrs where your proposal was discussed are as follows:.ichangir Ciillical L)evclopmcur Cenb~ I'tbicr Conimittei' Tehangirlloepiral PI Emiscs, 32. Sassoon Road. Pune ~ Ph. - f R %aa i 4
5 HEDICA RES EARC Jeha?gir PRIMARY AFFILIATION WITH SCIENTIFIC OR INSTITUTION (S) HIGHEST DEGREES NONSCIENTIFIC (YESINO; IF YES, MEMBER NAME EARNED SEX SPECIALTY WHICH S M.B.B.SID.AI Dr. Pratibha F Scientific No Consultant Dr. Mrs. Uma P. Divate F Scientific Yes Business man Mr. Framroze Garda B. Com, M.B.A M Non- Scientific Yes Mr. C.Y. Joshi B. B.A M Non- Scientific No Nutrionist, M.Sc -Statistics, Dr. Mrs.Shashi Phd- Statistics F Scientific Yes Social Worker, Mrs. Vn'nda Pusalkar M.S.W F Non- Scientific Yes Mrs. Stella Mendes M.A, L.L.B F Non- Scientific No Dr. Simi Mehra M.B.B.S.I PGDHA F Scientific Yes We approve the trial to be conducted in its presented form. Hirabai Cowasji Jehangir Medical Research Institute And Jehangir Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient Information/informed consent and asks to be provided a copy of the final report. We con(im, that Dr Mrs. U. P. Divate did not vote on the proposal for this study. We hereby confirm that Hirabai Cowasii Jehangir Medical Research Institute And Jehangir Ethics Committee is organized and operates as per GCP and applicable. regulations. Yours Sincerely, Signature Name ~J~g~7 ao,a. : Dr. Mrs. U.P Divate Member Secretary Hirabai Cowasji Jehsngir Medical Research Institute And Jehangir Ethics Committee iiilili):li (:?ii\iii:i li liilllpit ~l~tlii-ui ilc\~i;i~ii iii: liiliii.\ iii ~cha i~ir I)evsiopmt~nr Ccr:trL I:tl~ics Commi(iec Ichangir Hozpilal Prcmiser. 32, Sassooo Road. Pune Ph.- t ~,05')j 1X Fax- i Zh05g31')
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