= MEDICAL AND HEALTH RESEARCH ETHICS COMMITTEE (MHREC) (ay FACULTY OF MEDICINE GADJAH MADA UNIVERSITY LEA = DR. SARDJITO GENERAL HOSPITAL. ETHICS COMMITTEE APPROVAL Ref: KE/FK/OSOO/EC/2017 Title of the Research Protocol: Evaluasi Ekonomi Bevacizumab untuk Terapi Kanker Colorektal Metastase (mCRC) pada Regimen Kemoterapi Documents Approved : 1, Study Protocol versi 01 2017 2. Information for Subjects versi 02 2017 3. Informed consent form versi 02 2017 Principle Investigator : Dr. Ema Kristin, M.Si., Apt Participating Investigator(s): 1. Dr. Tri Murti Andayani, Sp.FRS., Apt 2. Dr. dr. Woro Rukmi Pratiwi, M.Kes., Sp.PD 3. Dwi Endarti, M.Sc., Apt., Ph.D 4. Dr. dr. Rizaldy T. Pinzon, M.Kes., Sp.S 5. Didik Setiawan, S.Farm., M.Sc., Ph.D 6. dr. Dwi Aris Agung Nugrahaningsih, M.Sc., Ph.D 7. de. Christiana Trijayanti Date of Approval : 02 MAY 2017 (Valid for one year beginning from the date of approval) Institution(s)/place(s) of 1. RSUP Dr. Sardjito, Yogyakarta research 2. RS Dharmais, Jakarta 3. RSUD Sanglah, Denpasar ‘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. ledical and Health Research Ethics Committee (MHREC) has the right to monitor the research at any time, ‘The investigator(s) is/are obliged to submit: 1 Progress report as a continuing review : Annually port of any serious adverse events (SAE) inal report upon the completion of the study Vb / ¢ Prof. dr. Madarina Julia, Sp.A(K)., MPH., Ph.D Vice Chairperson .D., Sp.MK Attachments: © Continuing review submission form (AF 4.3,01-014.2013-03) © Serious adverse events (SAE) report form (AF 6.1.01- 019.2013-03) Recognized by Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) 27-Apr-17