INSTITUTIONAL ETHICS COMMITTEE B. J. MEDICAL COLLEGE & SASSO ON GENERAL HOSPITALS, PUNE 1 REPORT OF INSTITUTIONAL ETHICS COMMITTEE Ref.No.: BJMCIIEC/Pharmac/ND121 0166-68 Date: 23-12-2010 (Always quote this reference number & date in correspondence) To. Dr.D. K. Damle Principle Investigator Department of Skin & V. D B.J. Medical College, Pune. Reference: ND 1210 166-68 I The INSTITUTIONAL ETHICS COMMITTEE B. J. ME6ICAL COLLEGE & SASSOON GENERAL HOSPITALS, PUl'rE 411 001 reviewed and discussed your research proposal entitled "A Randomized, Double-Blind, Multi-country, Multi-center, Vehicle-Controlled Study to Compare the Safety and Efficacy of Calcitriol Ointment 3 rncg/g (Paddock Laboratories,lnc.) vs. Vectical" Ointment 3 mcg/g (Galderma Laboratories, L.P.) in Treatment of Chronic Stable Mild to Moderate Plaque Psoriasis " on 23 rd December, 2010 The following documents were reviewed: (a) Protocol Id: PAD-2010-01 Dated: 02-12-2010 (b) Case Record form(Version 2.0), Informed Consent Form (English,Hindi,Marathi; Version 1.5), Subject diary (Version 1.3) (c) Investigator's Brochure: Calcitriol(Version 1.0) Package insert (d) Insurance policy: Raheja QBE Policy No.I-P0000034-MED (13-09-2010 to 12-09-2011) (e) Principal Investigator's current CV. (f) Clinical Study Agreement (g) Principal Investigator's Undertaking (h) DCGI Approval dated 13-12-2010 (i) Certificate from Head, Department of Skin & V. D, BJMC & SGH, Pune (j) Permission from Dean, BJMC & SGH, Pune C OM 4?/ ()~/'). i? \~C ~ I- ~-- ~"\ ) tU( \~'J.:-~J.~)'.J\"1_ -t .... <,~\13,,' .. \.: rJ.i ~~2>:;/ ..... 2