MINISTRY OF EDUCATION AND CULTURE FACULTY OF MEDICINE GADJAH MADA UNIVERSITY ETHICS COMMITTEE APPROVAL Ref: KE/FK/ 900 /EC Title of the Research Protocol: Efek 5-Fluorourasil dan Triamsinolon terhadap Sintesis Kolagen Fibroblas pada Keloid Documents Approved 1 Study Protocol versi 28 November 2012 Principle Investigator 8 Cee pier Name of supervisor : dr. Ishandono Dachlan, M.Sc., Sp.B., Sp.BP-RE(K) Name of medically : dr. Yohanes Widodo, Sp.KK(K) Responsible Physician(s) Date of Approval : 06 DEC 202 (Valid for one year beginning from the date of approval) Institution(s)/place(s) of Laboratorium Teknologi Kedokteran limu Kesehatan Kulit research dan Kelamin The Medical and Health Research Ethics Committee (MHREC) states that the above protocol meets the ethical principle outlined in the Declaration of Helsinki 2008 and therefore can be carried out. ‘The Medical research activi ind Health Research Ethics Committee (MHREC) has the right to monitor the ies at any time. The investigator(s) is/are obliged to submit: Progress report as a continuing review : Annually o Report of any serious adverse events (SAE) Final report upon the completion of the study Profdr. Mohammad Hakimi, Sp.0G (K),Ph.D Dr. dr. Eti Nurwening Sholikhah, M.Kes Chairman Secretary Attachments: 3 Continuing review submission form (AF 4.3.01-014.2012-02) 2 Serious adverse events (SAE) report form (AF 6.1.01- 019.2012-02)